Trial Outcomes & Findings for A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa (NCT NCT00257556)

Last Updated: 2010-02-26

Results Overview

Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

Approx week 13; 9 weeks or more after the 1st positive pregnancy test

Results posted on

2010-02-26

Participant Flow

Ninety (90) participants were screened and 80 participants randomized.

Participant milestones

Participant milestones
Measure	Menotrophin Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Study STARTED	38	42
Overall Study All Patients Treated Population	37	39
Overall Study COMPLETED	24	32
Overall Study NOT COMPLETED	14	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Menotrophin Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Study Adverse Event	1	4
Overall Study Physician Decision	6	0
Overall Study Did not meet hCG criterion	3	0
Overall Study other reason	4	6

Baseline Characteristics

A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Menotrophin n=37 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=39 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	39 Participants n=7 Participants	76 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	30.7 years STANDARD_DEVIATION 3.45 • n=5 Participants	30.9 years STANDARD_DEVIATION 2.67 • n=7 Participants	30.8 years STANDARD_DEVIATION 3.06 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	39 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Tobacco Use Smoker	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants
Tobacco Use Ex-smoker	8 participants n=5 Participants	5 participants n=7 Participants	13 participants n=5 Participants
Tobacco Use Never Smoked	25 participants n=5 Participants	26 participants n=7 Participants	51 participants n=5 Participants
Body Mass Index	24.02 Kilograms/Meters squared STANDARD_DEVIATION 3.689 • n=5 Participants	23.81 Kilograms/Meters squared STANDARD_DEVIATION 3.731 • n=7 Participants	23.91 Kilograms/Meters squared STANDARD_DEVIATION 3.687 • n=5 Participants
Diastolic Blood Pressure	74.1 mm Hg STANDARD_DEVIATION 8.83 • n=5 Participants	73.8 mm Hg STANDARD_DEVIATION 9.96 • n=7 Participants	74.0 mm Hg STANDARD_DEVIATION 9.37 • n=5 Participants
Pulse	75.7 beats per minute STANDARD_DEVIATION 9.63 • n=5 Participants	74.5 beats per minute STANDARD_DEVIATION 9.16 • n=7 Participants	75.1 beats per minute STANDARD_DEVIATION 9.35 • n=5 Participants
Systolic Blood Pressure	115.3 mm Hg STANDARD_DEVIATION 12.50 • n=5 Participants	116.1 mm Hg STANDARD_DEVIATION 14.55 • n=7 Participants	115.7 mm Hg STANDARD_DEVIATION 13.51 • n=5 Participants

PRIMARY outcome

Timeframe: Approx week 13; 9 weeks or more after the 1st positive pregnancy test

Population: All patients treated population

Outcome measures

Outcome measures
Measure	Menotrophin n=37 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=39 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Number of Participants With an Ongoing Pregnancy	14 participants	13 participants

PRIMARY outcome

Timeframe: Approx week 13; 9 weeks or more after the first positive pregnancy test

Population: All patients treated population. Two menotrophin patients did not have pregnancy outcome data recorded in this timeframe but were later recorded as having live births so are included here as "YES" for ongoing pregnancy.

Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.

Outcome measures

Outcome measures
Measure	Menotrophin n=37 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=39 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Percentage of Participants With an Ongoing Pregnancy	37.8 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)

Population: All treated patients population

The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met.

Outcome measures

Outcome measures
Measure	Menotrophin n=37 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=39 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters Did not meet criterion	10 participants	3 participants
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters 3 follicles ≥ 17 mm in diameter	11 participants	11 participants
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters 4 follicles ≥ 17 mm in diameter	7 participants	10 participants
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters 5 follicles ≥ 17 mm in diameter	2 participants	10 participants
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters 6 follicles ≥ 17 mm in diameter	4 participants	1 participants
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters 7 follicles ≥ 17 mm in diameter	0 participants	0 participants
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters 8 follicles ≥ 17 mm in diameter	1 participants	3 participants
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters 9 follicles ≥ 17 mm in diameter	0 participants	0 participants
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters 10 follicles ≥ 17 mm in diameter	1 participants	0 participants
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters 11-14 follicles ≥ 17 mm in diameter	0 participants	0 participants
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters 15 follicles ≥ 17 mm in diameter	0 participants	1 participants
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters 16 follicles ≥ 17 mm in diameter	1 participants	0 participants

SECONDARY outcome

Timeframe: Approximately study day 15

Population: All treated patients population.

Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with \>= 17mm in diameter.

Outcome measures

Outcome measures
Measure	Menotrophin n=23 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=29 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Participants With Varying Numbers of Oocytes Retrieved 2 oocytes retrieved	3 participants	1 participants
Participants With Varying Numbers of Oocytes Retrieved 3 oocytes retrieved	3 participants	1 participants
Participants With Varying Numbers of Oocytes Retrieved 4 oocytes retrieved	2 participants	2 participants
Participants With Varying Numbers of Oocytes Retrieved 5 oocytes retrieved	2 participants	5 participants
Participants With Varying Numbers of Oocytes Retrieved 6 oocytes retrieved	4 participants	4 participants
Participants With Varying Numbers of Oocytes Retrieved 7 oocytes retrieved	2 participants	2 participants
Participants With Varying Numbers of Oocytes Retrieved 8 oocytes retrieved	2 participants	4 participants
Participants With Varying Numbers of Oocytes Retrieved 9 oocytes retrieved	2 participants	2 participants
Participants With Varying Numbers of Oocytes Retrieved 10 oocytes retrieved	1 participants	3 participants
Participants With Varying Numbers of Oocytes Retrieved 11 oocytes retrieved	0 participants	0 participants
Participants With Varying Numbers of Oocytes Retrieved 12 oocytes retrieved	0 participants	4 participants
Participants With Varying Numbers of Oocytes Retrieved 13 oocytes retrieved	0 participants	1 participants
Participants With Varying Numbers of Oocytes Retrieved 14 oocytes retrieved	1 participants	0 participants
Participants With Varying Numbers of Oocytes Retrieved 15 oocytes retrieved	0 participants	3 participants
Participants With Varying Numbers of Oocytes Retrieved 16 oocytes retrieved	1 participants	2 participants
Participants With Varying Numbers of Oocytes Retrieved 17-18 oocytes retrieved	0 participants	0 participants
Participants With Varying Numbers of Oocytes Retrieved 19 oocytes retrieved	1 participants	2 participants
Participants With Varying Numbers of Oocytes Retrieved 20 oocytes retrieved	0 participants	0 participants
Participants With Varying Numbers of Oocytes Retrieved 21 oocytes retrieved	1 participants	0 participants
Participants With Varying Numbers of Oocytes Retrieved 22 oocytes retrieved	0 participants	0 participants
Participants With Varying Numbers of Oocytes Retrieved 23 oocytes retrieved	0 participants	1 participants
Participants With Varying Numbers of Oocytes Retrieved 0 oocytes retrieved	1 participants	0 participants
Participants With Varying Numbers of Oocytes Retrieved 1 oocyte retrieved	1 participants	1 participants

SECONDARY outcome

Timeframe: Approximately study day 15

Population: All patients treated population

Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.

Outcome measures

Outcome measures
Measure	Menotrophin n=25 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=35 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Participants With Varying Numbers of Pronuclear Stage Oocytes 1 pronuclear stage oocyte	1 participants	0 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 2 pronuclear stage oocytes	8 participants	6 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 3 pronuclear stage oocytes	1 participants	3 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 4 pronuclear stage oocytes	2 participants	7 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 5 pronuclear stage oocytes	4 participants	7 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 6 pronuclear stage oocytes	1 participants	0 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 7 pronuclear stage oocytes	2 participants	2 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 8 pronuclear stage oocytes	2 participants	2 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 9 pronuclear stage oocytes	1 participants	1 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 10 pronuclear stage oocytes	1 participants	1 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 11 pronuclear stage oocytes	2 participants	0 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 12 pronuclear stage oocytes	0 participants	4 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 13 pronuclear stage oocytes	0 participants	1 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 14-16 pronuclear stage oocytes	0 participants	0 participants
Participants With Varying Numbers of Pronuclear Stage Oocytes 17 pronuclear stage oocytes	0 participants	1 participants

SECONDARY outcome

Timeframe: Approximately study day 17

Population: All patients treated population

Number of participants with various categories of numbers of embryos transferred.

Outcome measures

Outcome measures
Measure	Menotrophin n=24 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=33 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Participants With Varying Numbers of Embryos Transferred 0 embryos transferred	0 participants	1 participants
Participants With Varying Numbers of Embryos Transferred 1 embryo transferred	3 participants	1 participants
Participants With Varying Numbers of Embryos Transferred 2 embryos transferred	21 participants	28 participants
Participants With Varying Numbers of Embryos Transferred 3 embryos transferred	0 participants	3 participants

SECONDARY outcome

Timeframe: Approximately study day 17

Population: All patients treated population

Number of participants with different categories of number of embryos frozen.

Outcome measures

Outcome measures
Measure	Menotrophin n=24 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=33 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Participants With Varying Numbers of Embryos Frozen 4 embryos frozen	4 participants	2 participants
Participants With Varying Numbers of Embryos Frozen 5 embryos frozen	0 participants	2 participants
Participants With Varying Numbers of Embryos Frozen 6-8 embryos frozen	0 participants	0 participants
Participants With Varying Numbers of Embryos Frozen 9 embryos frozen	0 participants	1 participants
Participants With Varying Numbers of Embryos Frozen 10 embryos frozen	0 participants	1 participants
Participants With Varying Numbers of Embryos Frozen 0 embryos frozen	16 participants	22 participants
Participants With Varying Numbers of Embryos Frozen 1 embryo frozen	1 participants	0 participants
Participants With Varying Numbers of Embryos Frozen 2 embryos frozen	2 participants	1 participants
Participants With Varying Numbers of Embryos Frozen 3 embryos frozen	1 participants	4 participants

SECONDARY outcome

Timeframe: study days 1 - 13

Population: All patients treated population

Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination.

Outcome measures

Outcome measures
Measure	Menotrophin n=37 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=39 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Mean Number of Days Stimulated With Gonadotrophins	9.2 days Standard Deviation 1.71	8.9 days Standard Deviation 1.07

SECONDARY outcome

Timeframe: Approximately 10 months

Population: All patients treated population

Long term follow-up to determine the outcome of the pregnancy.

Outcome measures

Outcome measures
Measure	Menotrophin n=17 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=17 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Pregnancy Outcomes Full term: 2 live births	3 participants	2 participants
Pregnancy Outcomes Miscarriage	4 participants	4 participants
Pregnancy Outcomes Pre-term: 1 live birth	1 participants	1 participants
Pregnancy Outcomes Pre-term: 2 live births	2 participants	3 participants
Pregnancy Outcomes Pre-term stillbirth	0 participants	1 participants
Pregnancy Outcomes Full term: 1 live birth	7 participants	6 participants

SECONDARY outcome

Timeframe: Day 7 or 9 or 11 or 13

Population: All patients treated population

Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.

Outcome measures

Outcome measures
Measure	Menotrophin n=27 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=38 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Mean Endometrial Thickness	11.7 millimeters Standard Deviation 2.73	11.0 millimeters Standard Deviation 2.31

SECONDARY outcome

Timeframe: Day 7 or 9 or 11 or 13

Population: All patient treated population

Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.

Outcome measures

Outcome measures
Measure	Menotrophin n=27 Participants Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=38 Participants A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Mean Estradiol Level	6706.6 picomoles / liter Standard Deviation 4109.26	6268.3 picomoles / liter Standard Deviation 4132.11

Adverse Events

Menotrophin

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Follitropin Alfa

Serious events: 9 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Menotrophin n=37 participants at risk Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=39 participants at risk A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Gastrointestinal disorders Abdominal Pain	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	5.1% 2/39 The 'all patients treated' population is the same as the safety population in this study.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	2.6% 1/39 The 'all patients treated' population is the same as the safety population in this study.
Gastrointestinal disorders Constipation	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	2.6% 1/39 The 'all patients treated' population is the same as the safety population in this study.
Gastrointestinal disorders Vomiting	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	2.6% 1/39 The 'all patients treated' population is the same as the safety population in this study.
General disorders Pyrexia	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	2.6% 1/39 The 'all patients treated' population is the same as the safety population in this study.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	2.7% 1/37 The 'all patients treated' population is the same as the safety population in this study.	7.7% 3/39 The 'all patients treated' population is the same as the safety population in this study.
Pregnancy, puerperium and perinatal conditions Abortion Imminent	2.7% 1/37 The 'all patients treated' population is the same as the safety population in this study.	0.00% 0/39 The 'all patients treated' population is the same as the safety population in this study.
Renal and urinary disorders Dysuria	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	2.6% 1/39 The 'all patients treated' population is the same as the safety population in this study.
Reproductive system and breast disorders Ovarian Hyperstimulation Syndrome	5.4% 2/37 The 'all patients treated' population is the same as the safety population in this study.	7.7% 3/39 The 'all patients treated' population is the same as the safety population in this study.
Reproductive system and breast disorders Uterine Haemorrhage	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	2.6% 1/39 The 'all patients treated' population is the same as the safety population in this study.
Reproductive system and breast disorders Vaginal Haemorrhage	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	2.6% 1/39 The 'all patients treated' population is the same as the safety population in this study.

Other adverse events

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restiction 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Menotrophin n=37 participants at risk Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)	Follitropin Alfa n=39 participants at risk A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Gastrointestinal disorders Abdominal Distension	2.7% 1/37 The 'all patients treated' population is the same as the safety population in this study.	10.3% 4/39 The 'all patients treated' population is the same as the safety population in this study.
Gastrointestinal disorders Abdominal Pain	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	5.1% 2/39 The 'all patients treated' population is the same as the safety population in this study.
Gastrointestinal disorders Abdominal Pain Lower	2.7% 1/37 The 'all patients treated' population is the same as the safety population in this study.	5.1% 2/39 The 'all patients treated' population is the same as the safety population in this study.
Gastrointestinal disorders Constipation	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	5.1% 2/39 The 'all patients treated' population is the same as the safety population in this study.
Gastrointestinal disorders Nausea	8.1% 3/37 The 'all patients treated' population is the same as the safety population in this study.	0.00% 0/39 The 'all patients treated' population is the same as the safety population in this study.
Gastrointestinal disorders Vomiting	2.7% 1/37 The 'all patients treated' population is the same as the safety population in this study.	7.7% 3/39 The 'all patients treated' population is the same as the safety population in this study.
General disorders Injection Site Bruising	8.1% 3/37 The 'all patients treated' population is the same as the safety population in this study.	5.1% 2/39 The 'all patients treated' population is the same as the safety population in this study.
General disorders Injection Site Erythema	16.2% 6/37 The 'all patients treated' population is the same as the safety population in this study.	10.3% 4/39 The 'all patients treated' population is the same as the safety population in this study.
General disorders Injection Site Haemorrhage	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	7.7% 3/39 The 'all patients treated' population is the same as the safety population in this study.
General disorders Injection Site Pruritus	18.9% 7/37 The 'all patients treated' population is the same as the safety population in this study.	5.1% 2/39 The 'all patients treated' population is the same as the safety population in this study.
General disorders Injection Site Rash	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	5.1% 2/39 The 'all patients treated' population is the same as the safety population in this study.
General disorders Injection Site Swelling	10.8% 4/37 The 'all patients treated' population is the same as the safety population in this study.	10.3% 4/39 The 'all patients treated' population is the same as the safety population in this study.
Infections and infestations Nasopharyngitis	5.4% 2/37 The 'all patients treated' population is the same as the safety population in this study.	0.00% 0/39 The 'all patients treated' population is the same as the safety population in this study.
Nervous system disorders Dizziness	2.7% 1/37 The 'all patients treated' population is the same as the safety population in this study.	5.1% 2/39 The 'all patients treated' population is the same as the safety population in this study.
Nervous system disorders Headache	2.7% 1/37 The 'all patients treated' population is the same as the safety population in this study.	15.4% 6/39 The 'all patients treated' population is the same as the safety population in this study.
Reproductive system and breast disorders Breast Tenderness	2.7% 1/37 The 'all patients treated' population is the same as the safety population in this study.	7.7% 3/39 The 'all patients treated' population is the same as the safety population in this study.
Reproductive system and breast disorders Ovarian Hyperstimulation Syndrome	5.4% 2/37 The 'all patients treated' population is the same as the safety population in this study.	10.3% 4/39 The 'all patients treated' population is the same as the safety population in this study.
Reproductive system and breast disorders Vaginal Haemorrhage	5.4% 2/37 The 'all patients treated' population is the same as the safety population in this study.	0.00% 0/39 The 'all patients treated' population is the same as the safety population in this study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/37 The 'all patients treated' population is the same as the safety population in this study.	5.1% 2/39 The 'all patients treated' population is the same as the safety population in this study.
Skin and subcutaneous tissue disorders Skin Reaction	5.4% 2/37 The 'all patients treated' population is the same as the safety population in this study.	7.7% 3/39 The 'all patients treated' population is the same as the safety population in this study.