Trial Outcomes & Findings for Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART) (NCT NCT04163458)

Results Overview

Fertilized oocytes with 2PN were regarded as correctly fertilized.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

405 participants

Primary outcome timeframe

On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)

Results posted on

2023-11-07

Participant Flow

The trial was performed in 19 investigational sites in US between Oct 2019 and Jul 2021.

In total, 691 participants were screened. Of these, 97 participants were rescreened after the trial hold was lifted, leading to a total of 788 screening events. Of these, 383 were screening event failures while 405 screening events resulted in randomization. 401 participants were exposed to IMP: 202 participants exposed to MENOPUR liquid and 199 participants were exposed to MENOPUR powder.

Participant milestones

Participant milestones
Measure	MENOPUR Liquid MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Overall Study STARTED	204	201
Overall Study mITT	202	199
Overall Study COMPLETED	180	171
Overall Study NOT COMPLETED	24	30

Reasons for withdrawal

Reasons for withdrawal
Measure	MENOPUR Liquid MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Overall Study Protocol Deviation	7	13
Overall Study Adverse Event	5	8
Overall Study Due to COVID-19 pandemic	4	2
Overall Study Participant withdrew consent	2	3
Overall Study Randomization failure	2	2
Overall Study Other	4	2

Baseline Characteristics

Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration	Total n=401 Participants Total of all reporting groups
Age, Continuous	33.9 Years STANDARD_DEVIATION 3.9 • n=5 Participants	34.0 Years STANDARD_DEVIATION 4.3 • n=7 Participants	34.0 Years STANDARD_DEVIATION 4.1 • n=5 Participants
Age, Customized Age · <35 years	111 Participants n=5 Participants	107 Participants n=7 Participants	218 Participants n=5 Participants
Age, Customized Age · >=35 years	91 Participants n=5 Participants	92 Participants n=7 Participants	183 Participants n=5 Participants
Sex: Female, Male Female	202 Participants n=5 Participants	199 Participants n=7 Participants	401 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	26 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	168 Participants n=5 Participants	173 Participants n=7 Participants	341 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants	19 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) White	158 Participants n=5 Participants	160 Participants n=7 Participants	318 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	202 participants n=5 Participants	199 participants n=7 Participants	401 participants n=5 Participants
Body Mass Index (BMI)	26.1 kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants	25.9 kg/m^2 STANDARD_DEVIATION 4.7 • n=7 Participants	26.0 kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants
Primary Infertility Yes	102 Participants n=5 Participants	102 Participants n=7 Participants	204 Participants n=5 Participants
Primary Infertility No	100 Participants n=5 Participants	97 Participants n=7 Participants	197 Participants n=5 Participants
Duration of infertility	46.1 Months STANDARD_DEVIATION 36.8 • n=5 Participants	44.5 Months STANDARD_DEVIATION 31.4 • n=7 Participants	45.3 Months STANDARD_DEVIATION 34.2 • n=5 Participants
Primary reason for infertility Unexplained infertility	91 Participants n=5 Participants	79 Participants n=7 Participants	170 Participants n=5 Participants
Primary reason for infertility Tubal infertility	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Primary reason for infertility Mild male factor	17 Participants n=5 Participants	27 Participants n=7 Participants	44 Participants n=5 Participants
Primary reason for infertility Moderate male factor	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Primary reason for infertility Severe male factor	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Primary reason for infertility Endometriosis stage I/II	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Primary reason for infertility Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)

Fertilized oocytes with 2PN were regarded as correctly fertilized.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Number of Fertilized (2 Pronuclei [2PN]) Oocytes	8.3 Fertilized oocytes Standard Deviation 5.5	6.7 Fertilized oocytes Standard Deviation 4.2

SECONDARY outcome

Timeframe: 10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation)

A blood serum βhCG test was obtained 10-14 days after blastocyst transfer. If the test was positive according to the local laboratory's reference ranges, this confirmed a positive βhCG.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Positive Beta Human Chorionic Gonadotropin (βhCG) Rate	113 Participants	110 Participants

SECONDARY outcome

Timeframe: 5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation)

Clinical pregnancy was based on detection of at least 1 intrauterine gestational sac with fetal heart beat on transvaginal ultrasound.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Clinical Pregnancy Rate	94 Participants	88 Participants

SECONDARY outcome

Timeframe: 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)

Ongoing pregnancy was based on detection of at least 1 intrauterine viable fetus by transvaginal or abdominal ultrasound

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Ongoing Pregnancy Rate	91 Participants	85 Participants

SECONDARY outcome

Timeframe: 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)

Population: Only participants who had a positive βhCG test were eligible.

Number of participants with early pregnancy loss defined as a positive βhCG tests but no ongoing pregnancy.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=113 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=110 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Early Pregnancy Loss	22 Participants	25 Participants

SECONDARY outcome

Timeframe: At stimulation Day 6

The total number of follicles and the number of follicles per size category were reported.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Follicular Development on Stimulation Day 6 Total number of follicles	17.0 Follicles Standard Deviation 9.4	16.5 Follicles Standard Deviation 8.3
Follicular Development on Stimulation Day 6 Follicles >= 12 mm	1.8 Follicles Standard Deviation 2.3	1.5 Follicles Standard Deviation 2.0
Follicular Development on Stimulation Day 6 Follicles >= 15 mm	0.2 Follicles Standard Deviation 0.6	0.2 Follicles Standard Deviation 0.6
Follicular Development on Stimulation Day 6 Follicles >= 17 mm	0.0 Follicles Standard Deviation 0.2	0.0 Follicles Standard Deviation 0.1

SECONDARY outcome

Timeframe: At last day of stimulation (up to 20 stimulation days)

The total number of follicles and the number of follicles per size category were reported.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Follicular Development on Last Day of Stimulation Follicles >= 15 mm	8.5 Follicles Standard Deviation 3.1	8.1 Follicles Standard Deviation 3.2
Follicular Development on Last Day of Stimulation Follicles >= 17 mm	5.4 Follicles Standard Deviation 2.3	5.2 Follicles Standard Deviation 2.2
Follicular Development on Last Day of Stimulation Total number of follicles	19.9 Follicles Standard Deviation 9.8	19.2 Follicles Standard Deviation 10.1
Follicular Development on Last Day of Stimulation Follicles >= 12 mm	13.1 Follicles Standard Deviation 5.2	12.0 Follicles Standard Deviation 5.1

SECONDARY outcome

Timeframe: At Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

The concentration of serum FSH was measured. The median and IQR of FSH levels on stimulation day 6, End of stimulation and Oocyte Retrieval visit are presented.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=201 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=198 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Serum Follicle-stimulating Hormone (FSH) Concentration Stimulation Day 6	16.7 IU/L Interval 14.1 to 20.2	14.9 IU/L Interval 12.8 to 17.2
Serum Follicle-stimulating Hormone (FSH) Concentration End of stimulation	17.6 IU/L Interval 13.9 to 22.5	16.5 IU/L Interval 13.8 to 20.5
Serum Follicle-stimulating Hormone (FSH) Concentration Oocyte retrieval	8.8 IU/L Interval 7.1 to 12.3	8.4 IU/L Interval 6.7 to 10.5

SECONDARY outcome

Timeframe: At the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

The concentration of serum AMH was measured. The median and IQR of AMH levels on End of stimulation and End of Trial are presented.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=201 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=192 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Serum Anti-Müllerian Hormone (AMH) Concentration End of trial	16.5 pmol/L Interval 10.1 to 24.0	15.5 pmol/L Interval 11.1 to 22.1
Serum Anti-Müllerian Hormone (AMH) Concentration End of stimulation	7.6 pmol/L Interval 5.4 to 12.3	8.7 pmol/L Interval 5.6 to 12.9

SECONDARY outcome

Timeframe: At Day 6 and last day of stimulation (up to 20 stimulation days)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

The concentration of hCG was measured. The median and IQR of hCG levels on stimulation day 6 and End of stimulation are presented.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=201 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=198 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Human Chorionic Gonadotropin (hCG) Concentration Stimulation Day 6	2.5 IU/L Interval 2.0 to 3.1	2.4 IU/L Interval 1.9 to 2.9
Human Chorionic Gonadotropin (hCG) Concentration End of stimulation	2.7 IU/L Interval 1.9 to 3.5	2.7 IU/L Interval 2.1 to 3.4

SECONDARY outcome

Timeframe: At Day 6 and last day of stimulation (up to 20 stimulation days)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

The concentration of LH was measured. The median and IQR of LH levels on stimulation day 6 and End of stimulation are presented.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=201 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=198 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Luteinizing Hormone (LH) Concentration End of stimulation	3.3 IU/L Interval 2.2 to 4.3	3.1 IU/L Interval 2.2 to 4.4
Luteinizing Hormone (LH) Concentration Stimulation Day 6	1.8 IU/L Interval 1.2 to 2.4	1.8 IU/L Interval 1.2 to 2.4

SECONDARY outcome

Timeframe: At Day 6 and last day of stimulation (up to 20 stimulation days)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

The concentration of P4 was measured. The median and IQR of P4 levels on stimulation day 6 and End of stimulation are presented.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=201 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=198 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Progesterone (P4) Concentration Stimulation Day 6	0.3 ng/mL Interval 0.2 to 0.4	0.3 ng/mL Interval 0.2 to 0.4
Progesterone (P4) Concentration End of stimulation	0.8 ng/mL Interval 0.6 to 1.1	0.6 ng/mL Interval 0.4 to 1.0

SECONDARY outcome

Timeframe: At stimulation Day 6 and last day of stimulation (up to 20 stimulation days)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

The concentration of E2 was measured. The median and IQR of E2 levels on stimulation day 6 and End of stimulation are presented.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=201 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=198 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Estradiol (E2) Concentration Stimulation Day 6	518.1 pg/mL Interval 236.7 to 834.0	336.4 pg/mL Interval 167.5 to 607.2
Estradiol (E2) Concentration End of stimulation	2720.0 pg/mL Interval 1994.0 to 3266.0	2292.0 pg/mL Interval 1694.0 to 2887.5

SECONDARY outcome

Timeframe: On day of oocyte retrieval (up to 22 days after start of stimulation)

The number of oocytes retrieved was recorded at the oocyte retrieval visit.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Number of Oocytes Retrieved	14.3 Oocytes Standard Deviation 8.1	11.4 Oocytes Standard Deviation 6.3

SECONDARY outcome

Timeframe: On day of oocyte retrieval (up to 22 days after start of stimulation)

Population: Only participants with Oocytes retrieved were eligible.

Maturity stage was assessed prior to undergoing ICSI. Maturity stage was categorized as germinal vesicle, metaphase I, metaphase II, degenerated or other.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=199 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=189 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Number of Metaphase II (MII) Oocytes	10.6 MII Oocytes Standard Deviation 6.1	8.9 MII Oocytes Standard Deviation 4.8

SECONDARY outcome

Timeframe: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)

Population: Only participants with Oocytes retrieved were eligible.

Fertilization rate(%) is the number of 2PN oocytes divided by the number of oocytes retrieved.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=199 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=189 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Fertilization Rate	57.8 Percentage Standard Deviation 19.9	60.0 Percentage Standard Deviation 20.9

SECONDARY outcome

Timeframe: On Day 5 after oocyte retrieval (up to 27 days after start of stimulation)

The number of blastocysts (total and good-quality) was reported. Blastocyst quality was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells)

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Number of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte Retrieval Number of Blastocysts on Day 5	4.8 Blastocysts Standard Deviation 3.8	3.9 Blastocysts Standard Deviation 3.0
Number of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte Retrieval Number of Good-quality blastocysts on Day 5	3.0 Blastocysts Standard Deviation 3.0	2.6 Blastocysts Standard Deviation 2.6

SECONDARY outcome

Timeframe: Up to 20 stimulation days

The gonadotropin starting dose was 225 IU for the first 5 days, followed by individual adjustments according to the participant's follicular response. Dose adjustment should be 75 IU per adjustment. Gonadotropin was to be initiated within 3 days of confirmed downregulation.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Total Gonadotropin Dose	2265.6 IU Standard Deviation 710.2	2466.7 IU Standard Deviation 863.5

SECONDARY outcome

Timeframe: Up to 20 stimulation days

Calculated by start dates and end dates.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Number of Stimulation Days	9.6 Days Standard Deviation 1.7	9.9 Days Standard Deviation 1.8

SECONDARY outcome

Timeframe: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)

OHSS was defined as the total of early OHSS with onset ≤9 days after triggering of final follicular maturation, and late OHSS with onset \>9 days after triggering of final follicular maturation.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Proportion of Participants With Ovarian Hyperstimulation Syndrome (OHSS) Early OHSS	3.5 Percentage of participants	3.5 Percentage of participants
Proportion of Participants With Ovarian Hyperstimulation Syndrome (OHSS) Late OHSS	4.0 Percentage of participants	1.5 Percentage of participants

SECONDARY outcome

Timeframe: From the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months)

Any AE occurring after start of IMP and before the end-of-trial visit, or a pre-treatment AE or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Frequency of Adverse Events (AEs)	50.0 Percentage of participants	52.3 Percentage of participants

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

The intensity of an AE was classified using the following 3-point scale: Mild = Awareness of signs or symptoms, but no disruption of usual activity. Moderate = Event sufficient to affect usual activity (disturbing). Severe = Inability to work or perform usual activities (unacceptable).

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Intensity of AEs Mild AEs	42.1 Percentage of participants	40.7 Percentage of participants
Intensity of AEs Moderate AEs	23.8 Percentage of participants	20.6 Percentage of participants
Intensity of AEs Severe AEs	0.5 Percentage of participants	2.0 Percentage of participants

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=196 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=185 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Alanine Aminotransferase	0.4 IU/L Standard Deviation 14.2	-1.0 IU/L Standard Deviation 12.4

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=196 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=185 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Aspartate Aminotransferase	-0.9 IU/L Standard Deviation 8.8	-2.1 IU/L Standard Deviation 21.1

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=196 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=185 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Blood Urea Nitrogen	-0.7 mmol/L Standard Deviation 1.2	-0.7 mmol/L Standard Deviation 1.3

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=196 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=185 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Calcium	-0.03 mmol/L Standard Deviation 0.10	-0.03 mmol/L Standard Deviation 0.08

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=196 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=185 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Chloride	0.4 mmol/L Standard Deviation 2.3	0.3 mmol/L Standard Deviation 2.2

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=196 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=185 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Creatinine	-5.498 umol/L Standard Deviation 10.896	-5.032 umol/L Standard Deviation 8.849

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=196 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=185 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Gamma Glutamyl Transferase	-0.6 IU/L Standard Deviation 5.6	-1.6 IU/L Standard Deviation 8.9

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=196 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=185 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Glucose	0.0 mmol/L Standard Deviation 0.8	-0.1 mmol/L Standard Deviation 0.9

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=196 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=185 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Potassium	-0.04 mmol/L Standard Deviation 0.38	-0.05 mmol/L Standard Deviation 0.40

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=196 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=185 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Sodium	-1.0 mmol/L Standard Deviation 3.0	-0.8 mmol/L Standard Deviation 3.1

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=23 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=19 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr African American	7.7 mL/min/1.73m2 Standard Deviation 14.9	2.4 mL/min/1.73m2 Standard Deviation 13.7

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=173 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=166 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr Non-afr. American	6.3 mL/min/1.73m2 Standard Deviation 13.1	5.9 mL/min/1.73m2 Standard Deviation 11.6

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Erythrocytes	-0.169 10^12 cells/L Standard Deviation 0.293	-0.199 10^12 cells/L Standard Deviation 0.256

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Leukocytes	1.17 10^9 cells/L Standard Deviation 2.25	1.11 10^9 cells/L Standard Deviation 2.09

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hemoglobin	-4.40 g/L Standard Deviation 9.87	-5.76 g/L Standard Deviation 8.02

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hematocrit	-0.02 RATIO Standard Deviation 0.03	-0.02 RATIO Standard Deviation 0.03

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=182 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Platelets	22.6 10^9 cells/L Standard Deviation 38.6	23.7 10^9 cells/L Standard Deviation 43.2

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils	1.7 cells/uL Standard Deviation 54.0	-0.1 cells/uL Standard Deviation 60.6

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils/Leukocytes	-0.1 Basophils/leukocytes in Percentage Standard Deviation 0.8	-0.2 Basophils/leukocytes in Percentage Standard Deviation 1.0

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils	-10.6 cells/uL Standard Deviation 100.5	4.2 cells/uL Standard Deviation 68.6

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils/Leukocytes	-0.4 Eosinophils/leukocytes in percentage Standard Deviation 1.6	-0.1 Eosinophils/leukocytes in percentage Standard Deviation 1.2

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes	-53.2 cells/uL Standard Deviation 414.9	-4.0 cells/uL Standard Deviation 442.5

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes/Leukocytes	-4.5 Lymphocytes/leukocytes in percentage Standard Deviation 9.6	-3.4 Lymphocytes/leukocytes in percentage Standard Deviation 9.5

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes	21.5 cells/uL Standard Deviation 161.8	36.7 cells/uL Standard Deviation 148.9

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes/Leukocytes	-0.8 Monocytes/leukocytes in percentage Standard Deviation 1.7	-0.5 Monocytes/leukocytes in percentage Standard Deviation 1.6

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils	1206.4 cells/uL Standard Deviation 2096.6	1069.0 cells/uL Standard Deviation 1966.0

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=197 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=183 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils/Leukocytes	5.7 Neutrophils/leukocytes in percentage Standard Deviation 11.2	4.2 Neutrophils/leukocytes in percentage Standard Deviation 10.6

SECONDARY outcome

Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. Participants who were evaluable had normal baseline values and markedly abnormal end-of-stimulation or end-of-trial visit values.

The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial visit values. It is only parameters with markedly abnormal values at end of stimulation or end of trial visit which are represented. Parameters with normal baseline values and normal end of stimulation and end of trial values are not represented.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=198 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=189 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters Leukocytes (10^9 cells/L) (End of trial)	1 Participants	1 Participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters Calcium (mmol/L) (End of stimulation)	1 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters Glucose (mmol/L) (End of stimulation)	1 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters Erythrocytes (10^12 cells/L) (End of stimulation)	2 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters Leukocytes (10^9 cells/L) (End of stimulation)	2 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters Hemoglobin (g/L) (End of stimulation)	2 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters Hematocrit (RATIO) (End of stimulation)	2 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters Platelets (10^9 cells/L) (End of stimulation)	1 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters Basophils/leukocytes ratio (%) (End of stimulation)	1 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters Lymphocytes/leukocytes ratio (%) (End of stimulation)	2 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters Alanine Aminotransferase (IU/L) (End of trial)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 20 stimulation days

Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection. Total Number of events include all categories None, Mild, Moderate and Severe. Percentage of events with injection site reactions as a sum of the categories Mild, Moderate and Severe is presented.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=29185 Total number of events MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=29425 Total number of events MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period	6.3 Percentage of events	14.5 Percentage of events

SECONDARY outcome

Timeframe: Up to 20 stimulation days

Assessed by the participant during the stimulation period as mild, moderate or severe. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=29185 Total number of events MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=29425 Total number of events MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period Mild injection site reaction	6.1 Percentage of events	12.9 Percentage of events
Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period Moderate injection site reaction	0.2 Percentage of events	1.4 Percentage of events
Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period Severe injection site reaction	0.0069 Percentage of events	0.2 Percentage of events

SECONDARY outcome

Timeframe: Up to 28 days after end of the stimulation period (simulation period up to 20 days)

Measured by presence of anti-MENOPUR antibodies. 95% Clopper-Pearson confidence interval has been reported in this endpoint.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Proportion of Participants With Treatment-induced Anti-MENOPUR Antibodies. Overall as Well as With Neutralizing Capacity Treatment-induced anti-MENOPUR antibodies (overall)	1.5 Percentage of participants Interval 0.3 to 4.3	1.5 Percentage of participants Interval 0.3 to 4.3
Proportion of Participants With Treatment-induced Anti-MENOPUR Antibodies. Overall as Well as With Neutralizing Capacity Treatment-induced anti-MENOPUR antibodies with neutralizing capacity	0 Percentage of participants Interval 0.0 to 1.81	0 Percentage of participants Interval 0.0 to 1.84

SECONDARY outcome

Timeframe: Up to 20 stimulation days

Number of participants With Potential Technical malfunctions of the Administration Pen were recorded.

Outcome measures

Outcome measures
Measure	MENOPUR Liquid n=202 Participants MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 Participants MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Number of Participants With Potential Technical Malfunctions of the Administration Pen	1 Participants	1 Participants

Adverse Events

MENOPUR Liquid

Serious events: 4 serious events

Other events: 101 other events

Deaths: 0 deaths

MENOPUR Powder

Serious events: 2 serious events

Other events: 104 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MENOPUR Liquid n=202 participants at risk MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 participants at risk MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	2.0% 4/202 • Number of events 4 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	1.0% 2/199 • Number of events 2 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Nervous system disorders Unresponsive to stimuli	0.00% 0/202 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	0.50% 1/199 • Number of events 1 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).

Other adverse events

Additional Information

Global Clinical Compliance

Ferring Pharmaceuticals

Phone: -

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
Publication restrictions are in place

Restriction type: OTHER

Measure	MENOPUR Liquid n=202 participants at risk MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration	MENOPUR Powder n=199 participants at risk MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration
Gastrointestinal disorders Constipation	3.0% 6/202 • Number of events 6 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	1.5% 3/199 • Number of events 3 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Gastrointestinal disorders Nausea	1.5% 3/202 • Number of events 3 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	2.0% 4/199 • Number of events 4 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Gastrointestinal disorders Abdominal pain	1.5% 3/202 • Number of events 3 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	1.0% 2/199 • Number of events 2 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Gastrointestinal disorders Diarrhoea	1.5% 3/202 • Number of events 3 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	0.50% 1/199 • Number of events 1 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Infections and infestations Corona virus infection	0.00% 0/202 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	3.5% 7/199 • Number of events 7 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Infections and infestations Vulvovaginal mycotic infection	1.5% 3/202 • Number of events 3 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	1.5% 3/199 • Number of events 3 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Injury, poisoning and procedural complications Procedural pain	19.3% 39/202 • Number of events 40 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	19.1% 38/199 • Number of events 38 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Injury, poisoning and procedural complications Post procedural discomfort	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	2.0% 4/199 • Number of events 4 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Injury, poisoning and procedural complications Procedural nausea	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	2.0% 4/199 • Number of events 4 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Nervous system disorders Headache	3.0% 6/202 • Number of events 6 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	6.0% 12/199 • Number of events 13 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Nervous system disorders Migraine	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	1.5% 3/199 • Number of events 3 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Nervous system disorders Dizziness	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	1.0% 2/199 • Number of events 2 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Pregnancy, puerperium and perinatal conditions Morning sickness	8.9% 18/202 • Number of events 22 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	11.1% 22/199 • Number of events 26 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	6.9% 14/202 • Number of events 14 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	5.5% 11/199 • Number of events 11 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Pregnancy, puerperium and perinatal conditions Biochemical pregnancy	3.5% 7/202 • Number of events 7 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	6.5% 13/199 • Number of events 13 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Pregnancy, puerperium and perinatal conditions Haemorrhage in pregnancy	4.0% 8/202 • Number of events 8 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	2.5% 5/199 • Number of events 5 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Pregnancy, puerperium and perinatal conditions Subchorionic haemorrhage	2.0% 4/202 • Number of events 4 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	0.50% 1/199 • Number of events 1 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Pregnancy, puerperium and perinatal conditions Subchorionic haematoma	1.5% 3/202 • Number of events 3 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	1.0% 2/199 • Number of events 2 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Pregnancy, puerperium and perinatal conditions Uterine contractions during pregnancy	0.50% 1/202 • Number of events 2 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	1.5% 3/199 • Number of events 3 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Reproductive system and breast disorders Pelvic discomfort	8.4% 17/202 • Number of events 19 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	5.0% 10/199 • Number of events 13 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	7.4% 15/202 • Number of events 15 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	5.0% 10/199 • Number of events 10 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Reproductive system and breast disorders Pelvic pain	6.9% 14/202 • Number of events 15 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	4.0% 8/199 • Number of events 9 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Reproductive system and breast disorders Breast tenderness	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	1.0% 2/199 • Number of events 2 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).
Reproductive system and breast disorders Vaginal haemorrhage	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).	1.0% 2/199 • Number of events 2 • Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).