Trial Outcomes & Findings for A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization (NCT NCT01850030)

NCT ID: NCT01850030

Last Updated: 2018-01-02

Results Overview

Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1070 participants
• Primary outcome timeframe: 12 weeks´ gestation (at visit 6)
• Results posted on: 2018-01-02

Participant Flow

1070 subjects were enrolled in the study and 1031 subjects were randomized

Participant milestones

Measure	Dydrogesterone 30 mg Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid	Micronized Progesterone 600 mg Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid
Overall Study STARTED	520	511
Overall Study COMPLETED	173	142
Overall Study NOT COMPLETED	347	369

Reasons for withdrawal

Measure	Dydrogesterone 30 mg Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid	Micronized Progesterone 600 mg Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid
Overall Study Adverse Event	64	82
Overall Study Lack of Efficacy	3	1
Overall Study Lost to Follow-up	5	5
Overall Study Withdrawal by Subject	3	4
Overall Study Protocol Violation	24	28
Overall Study pregnancy not confirmed at visit 4	248	249

Baseline Characteristics

A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization

Baseline characteristics by cohort

Measure	Dydrogesterone 30 mg n=497 Participants Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid	Micronized Progesterone 600 mg n=477 Participants Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid	Total n=974 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	497 Participants n=5 Participants	477 Participants n=7 Participants	974 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	32.5 years STANDARD_DEVIATION 4.5 • n=5 Participants	32.5 years STANDARD_DEVIATION 4.4 • n=7 Participants	32.5 years STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male Female	497 Participants n=5 Participants	477 Participants n=7 Participants	974 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Austria	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Russian Federation	106 participants n=5 Participants	103 participants n=7 Participants	209 participants n=5 Participants
Region of Enrollment Belgium	194 participants n=5 Participants	182 participants n=7 Participants	376 participants n=5 Participants
Region of Enrollment Finland	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Israel	69 participants n=5 Participants	66 participants n=7 Participants	135 participants n=5 Participants
Region of Enrollment Germany	62 participants n=5 Participants	60 participants n=7 Participants	122 participants n=5 Participants
Region of Enrollment Spain	55 participants n=5 Participants	54 participants n=7 Participants	109 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks´ gestation (at visit 6)

Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound

Outcome measures

Measure	Dydrogesterone 30 mg n=497 Participants Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid	Micronized Progesterone 600 mg n=477 Participants Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid
Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound	37.6 percentage of participants Interval 33.4 to 42.1	33.1 percentage of participants Interval 28.9 to 37.6

SECONDARY outcome

Timeframe: Day 14 after embryo transfer

Percentage of participants being pregnant as measured by the positive biochemical pregnancy test on Day 14 after embryo transfer

Outcome measures

Measure	Dydrogesterone 30 mg n=497 Participants Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid	Micronized Progesterone 600 mg n=477 Participants Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid
Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer	47.1 percentage of participants Interval 42.6 to 51.6	45.5 percentage of participants Interval 41.0 to 50.1

SECONDARY outcome

Timeframe: After delivery (about 9 months after IVF)

Incidence of live births and healthy newborns

Outcome measures

Measure	Dydrogesterone 30 mg n=497 Participants Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid	Micronized Progesterone 600 mg n=477 Participants Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid
Percentage of Participants With a Successful Completion of Pregnancy Live birth rate	34.6 percentage of participants Interval 30.4 to 39.0	29.8 percentage of participants Interval 25.7 to 34.1
Percentage of Participants With a Successful Completion of Pregnancy Healthy newborn rate	32 percentage of participants Interval 27.9 to 36.3	27.7 percentage of participants Interval 23.7 to 31.9

SECONDARY outcome

Timeframe: After delivery (about 9 months after IVF)

was recorded and collected for Newborn

Outcome measures

Measure	Dydrogesterone 30 mg n=213 Participants Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid	Micronized Progesterone 600 mg n=158 Participants Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid
Gender of the Newborn Gender male	120 number of newborns	88 number of newborns
Gender of the Newborn Gender female	93 number of newborns	70 number of newborns

Adverse Events

Dydrogesterone 30 mg

Serious events: 56 serious events

Other events: 156 other events

Deaths: 0 deaths

Micronized Progesterone 600 mg

Serious events: 68 serious events

Other events: 147 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dydrogesterone 30 mg n=518 participants at risk Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid	Micronized Progesterone 600 mg n=511 participants at risk Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid
Pregnancy, puerperium and perinatal conditions spontaneous abortion	2.1% 11/518 • Number of events 11 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	3.1% 16/511 • Number of events 16 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions abortion not specified as induced or spontaneous	1.4% 7/518 • Number of events 7 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	2.2% 11/511 • Number of events 11 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions maternal complications of pregnancy	1.5% 8/518 • Number of events 8 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	1.4% 7/511 • Number of events 7 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions labor onset and length abnormalities	1.4% 7/518 • Number of events 7 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.98% 5/511 • Number of events 7 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Still birth and foetal death	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	1.2% 6/511 • Number of events 6 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Foetal complications NEC	0.39% 2/518 • Number of events 2 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.59% 3/511 • Number of events 3 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Hypertension associated disorders of pregnancy	0.39% 2/518 • Number of events 3 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.39% 2/511 • Number of events 3 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Amniotic fluid and cavity disorders of pregnancy NEC	0.39% 2/518 • Number of events 3 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Gestational age and weight conditions	0.39% 2/518 • Number of events 2 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Haemorrhagic complications of pregnancy	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.39% 2/511 • Number of events 3 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions High risk pregnancies	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Normal pregnancy, labour and delivery	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Umbilical cord complications	0.39% 2/518 • Number of events 2 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Abortion related conditions and complications	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions foetal growth complications	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions maternal complications of delivery NEC	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Postpartum complications NEC	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Reproductive system and breast disorders Ovarian and fallopian tube disorders NEC	1.5% 8/518 • Number of events 8 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	1.2% 6/511 • Number of events 7 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Reproductive system and breast disorders Cervix disorders	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Reproductive system and breast disorders Ovarian and fallopian tube cysts and neoplasms	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Reproductive system and breast disorders Menstruation and uterine bleeding NEC	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Reproductive system and breast disorders Reproductive tract disorders NEC (excl neoplasms)	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Reproductive system and breast disorders Vulvovaginal disorders NEC	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Surgical and medical procedures Induced abortions	0.58% 3/518 • Number of events 3 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.78% 4/511 • Number of events 4 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Surgical and medical procedures Obstetric therapeutic procedures	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders Autosomal chromosomal abnormalities	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.59% 3/511 • Number of events 3 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders Arterial disorders congenital	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders Cardiac septal defects congenital	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders Cardiac valve disorders congenital	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders Central nervous system disorders congenital NEC	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders Cerebral disorders congenital	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders Sex chromosomal abnormalities	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Gastrointestinal disorders Gastrointestinal and abdominal pains (excl oral and throat)	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.78% 4/511 • Number of events 4 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Vascular disorders Peripheral embolism and thrombosis	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Vascular disorders Vascular hypertensive disorders NEC	0.19% 1/518 • Number of events 2 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Vascular disorders haemorrhages NEC	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Infections and infestations Abdominal and gastrointestinal infections	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Infections and infestations cytomegaloviral infections	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Infections and infestations infections NEC	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Infections and infestations Urinary tract infections	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Injury, poisoning and procedural complications non-site specific injuries NEC	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Injury, poisoning and procedural complications Non-site specific procedural complications	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Injury, poisoning and procedural complications Renal and urinary tract injuries NEC	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Nervous system disorders Autonomic nervous system disorders	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Nervous system disorders Neurological signs and symptoms NEC	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Nervous system disorders Seizures and seizure disorders NEC	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Cardiac disorders Rate and rythm disorders NEC	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Investigations Foetal and neonatal diagnostic procedures	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Investigations protein analyses NEC	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Blood and lymphatic system disorders Anaemias NEC	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Blood and lymphatic system disorders Thrombocytopenias	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Metabolism and nutrition disorders Potassium imbalance	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Renal and urinary disorders Urinary abnormalities	0.19% 1/518 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.00% 0/511 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Respiratory, thoracic and mediastinal disorders Nasal disorders	0.00% 0/518 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	0.20% 1/511 • Number of events 1 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)

Other adverse events

Measure	Dydrogesterone 30 mg n=518 participants at risk Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid	Micronized Progesterone 600 mg n=511 participants at risk Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid
Reproductive system and breast disorders Vaginal haemorrhage	11.8% 61/518 • Number of events 75 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	8.8% 45/511 • Number of events 53 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Injury, poisoning and procedural complications Procedural pain	7.3% 38/518 • Number of events 39 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	8.0% 41/511 • Number of events 42 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Gastrointestinal disorders Nausea	8.5% 44/518 • Number of events 46 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	5.1% 26/511 • Number of events 27 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Gastrointestinal disorders Abdominal pain	4.6% 24/518 • Number of events 25 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	6.1% 31/511 • Number of events 33 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Nervous system disorders Headache	5.2% 27/518 • Number of events 31 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	6.3% 32/511 • Number of events 36 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Pregnancy of unknown location	3.7% 19/518 • Number of events 19 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)	5.7% 29/511 • Number of events 29 For Adverse Events reporting the safety sample was used consisting of all subjects which have received at least one administration of study drug (518 subjects in Dydrogesterone, 511 subjects in Micronized Progesterone)

Additional Information

Erik van Leeuwen MSc, PMP

Abbott

Phone: +31294479241

Email: erik.vanleeuwen@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow sponsor sixty (60) days to review and comment on them. If the Sponsor requests, the Site shall remove any Confidential Information (other than Study results) prior to submitting or presenting the materials.
• Publication restrictions are in place

Restriction type: OTHER