Trial Outcomes & Findings for A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II) (NCT NCT02491437)

NCT ID: NCT02491437

Last Updated: 2019-10-01

Results Overview

Pregnancy rate defined as the presence of fetal heart beats at 12 weeks' gestation determined by transvaginal ultrasound.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1034 participants
• Primary outcome timeframe: 12 weeks´ gestation
• Results posted on: 2019-10-01

Participant Flow

Participant milestones

Measure	Dydrogesterone Tablets 3x10 mg Dydrogesterone tablets 3x10 mg Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid	Crinone 8% Intravaginal Progesterone Gel 90 mg Crinone 8% intravaginal progesterone gel 90 mg intravaginal progesterone gel 90 mg OD
Overall Study STARTED	520	514
Overall Study Safety Sample	518	512
Overall Study Full Analysis Sample	494	489
Overall Study COMPLETED	168	157
Overall Study NOT COMPLETED	352	357

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)

Baseline characteristics by cohort

Measure	Dydrogesterone Tablets 3x10 mg n=494 Participants Dydrogesterone tablets 3x10 mg Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid	Crinone 8% Intravaginal Progesterone Gel 90 mg n=489 Participants Crinone 8% intravaginal progesterone gel 90 mg intravaginal progesterone gel 90 mg OD	Total n=983 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	494 Participants n=5 Participants	489 Participants n=7 Participants	983 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	31.8 years STANDARD_DEVIATION 4.4 • n=5 Participants	31.6 years STANDARD_DEVIATION 4.6 • n=7 Participants	31.7 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	494 Participants n=5 Participants	489 Participants n=7 Participants	983 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	250 Participants n=5 Participants	237 Participants n=7 Participants	487 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	237 Participants n=5 Participants	247 Participants n=7 Participants	484 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	5 Participants n=7 Participants	11 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 Singapore	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Belgium	80 participants n=5 Participants	85 participants n=7 Participants	165 participants n=5 Participants
Region of Enrollment Hong Kong	9 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment China	114 participants n=5 Participants	108 participants n=7 Participants	122 participants n=5 Participants
Region of Enrollment Ukraine	45 participants n=5 Participants	46 participants n=7 Participants	91 participants n=5 Participants
Region of Enrollment Thailand	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants
Region of Enrollment Australia	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Germany	78 participants n=5 Participants	79 participants n=7 Participants	157 participants n=5 Participants
Region of Enrollment India	103 participants n=5 Participants	100 participants n=7 Participants	203 participants n=5 Participants
Region of Enrollment Russia	39 participants n=5 Participants	41 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks´ gestation

Population: Full Analysis Sample (FAS)

Pregnancy rate defined as the presence of fetal heart beats at 12 weeks' gestation determined by transvaginal ultrasound.

Outcome measures

Measure	Dydrogesterone Tablets 3x10 mg n=494 Participants Dydrogesterone tablets 3x10 mg Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid	Crinone 8% Intravaginal Progesterone Gel 90 mg n=489 Participants Crinone 8% intravaginal progesterone gel 90 mg intravaginal progesterone gel 90 mg OD
Percentage of Participants With Presence of Fetal Heart Beats at 12 Week's Gestation Determined by Transvaginal Ultrasound	38.7 percentage of participants Interval 34.4 to 43.1	35.0 percentage of participants Interval 30.7 to 39.4

SECONDARY outcome

Timeframe: Day 14 after embryo transfer

Population: Full Analysis Sample (FAS)

Positive biochemical pregnancy test on Day 14 after embryo transfer

Outcome measures

Measure	Dydrogesterone Tablets 3x10 mg n=494 Participants Dydrogesterone tablets 3x10 mg Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid	Crinone 8% Intravaginal Progesterone Gel 90 mg n=489 Participants Crinone 8% intravaginal progesterone gel 90 mg intravaginal progesterone gel 90 mg OD
Positive Pregnancy Test Rate (Percentage of Participants With a Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer)	47.4 percentage of participants Interval 42.9 to 51.9	43.8 percentage of participants Interval 39.3 to 48.3

SECONDARY outcome

Timeframe: After delivery (about 9 months after IVF)

Population: Full Analysis Sample (FAS)

Live birth rate (percentage of participants with a live birth)

Outcome measures

Measure	Dydrogesterone Tablets 3x10 mg n=494 Participants Dydrogesterone tablets 3x10 mg Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid	Crinone 8% Intravaginal Progesterone Gel 90 mg n=489 Participants Crinone 8% intravaginal progesterone gel 90 mg intravaginal progesterone gel 90 mg OD
Rate of Successful Completion of Pregnancy (Percentage of Participants With a Live Birth)	34.4 percentage of participants Interval 30.2 to 38.8	32.5 percentage of participants Interval 28.4 to 36.9

SECONDARY outcome

Timeframe: After delivery (about 9 months after IVF)

Population: Full Analysis Sample (FAS). These are the number of delivered babies from the mothers in the FAS

The gender (number of delivered newborns that are male or female)

Outcome measures

Measure	Dydrogesterone Tablets 3x10 mg n=205 Participants Dydrogesterone tablets 3x10 mg Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid	Crinone 8% Intravaginal Progesterone Gel 90 mg n=188 Participants Crinone 8% intravaginal progesterone gel 90 mg intravaginal progesterone gel 90 mg OD
Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female) Gender male	105 number of newborns	95 number of newborns
Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female) Gender female	100 number of newborns	93 number of newborns

Adverse Events

Dydrogesterone Tablets 3x10 mg (Maternal)

Serious events: 71 serious events

Other events: 50 other events

Deaths: 0 deaths

Crinone 8% Intravaginal Progesterone Gel 90 mg (Maternal)

Serious events: 67 serious events

Other events: 35 other events

Deaths: 0 deaths

Dydrogesterone Tablets (Fetus/Newborn)

Serious events: 28 serious events

Other events: 0 other events

Deaths: 4 deaths

Crinone 8% Intravaginal Progesterone Gel (Fetus/Newborn)

Serious events: 23 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dydrogesterone Tablets 3x10 mg (Maternal) n=518 participants at risk Dydrogesterone tablets 3x10 mg Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid	Crinone 8% Intravaginal Progesterone Gel 90 mg (Maternal) n=512 participants at risk Crinone 8% intravaginal progesterone gel 90 mg Intravaginal progesterone gel 90 mg OD	Dydrogesterone Tablets (Fetus/Newborn) n=221 participants at risk Maternal dosing of Dydrogesterone tablets 3x10 mg 221 subjects at risk=205 live births + 16 abortions/stillbirths	Crinone 8% Intravaginal Progesterone Gel (Fetus/Newborn) n=201 participants at risk Maternal dosing of Crinone 8% intravaginal progesterone gel 90 mg 201 subjects at risk = 188 live births + 13 abortions/stillbirths
Pregnancy, puerperium and perinatal conditions abortions spontaneous (related to the mother)	2.3% 12/518 • Number of events 12 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	2.7% 14/512 • Number of events 14 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions maternal complications of pregnancy (related to the mother)	1.5% 8/518 • Number of events 8 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	2.1% 11/512 • Number of events 11 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions labour onset and length abnormalities (related to the mother)	2.3% 12/518 • Number of events 13 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	1.2% 6/512 • Number of events 7 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions abortion not specified as induced or spontaneous (related to the mother)	2.5% 13/518 • Number of events 13 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.78% 4/512 • Number of events 4 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions gestational age and weight conditions (related to the mother)	1.4% 7/518 • Number of events 7 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	1.2% 6/512 • Number of events 6 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions still birth and foetal death (related to the mother)	0.39% 2/518 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.98% 5/512 • Number of events 5 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions Hypertension associated disorders of pregnancy (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.78% 4/512 • Number of events 4 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions placental abnormalities (excl neoplasms) (related to the mother)	0.58% 3/518 • Number of events 3 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions haeomorrhagic complications of pregnancy (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.39% 2/512 • Number of events 3 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions abortion related conditions and complications (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions pregnancy complicated by maternal disorders (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions amniotic fluid and cavity disorders of pregnancy (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions maternal complications of delivery (related to the mother)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions postpartum complications (related to the mother)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Reproductive system and breast disorders ovarium and fallopian tube disorders (related to the mother)	2.1% 11/518 • Number of events 12 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	2.9% 15/512 • Number of events 15 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Reproductive system and breast disorders vulvovaginal disorders (related to the mother)	0.39% 2/518 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.39% 2/512 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Reproductive system and breast disorders Uterine disorders (related to the mother)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Surgical and medical procedures induced abortions (related to the mother)	0.77% 4/518 • Number of events 4 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.59% 3/512 • Number of events 3 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Surgical and medical procedures obstetric therapeutic procedures (related to the mother)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.39% 2/512 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Gastrointestinal disorders gastrointestinal and abdominal pains (excl oral and throat) (related to the mother)	0.39% 2/518 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Gastrointestinal disorders flatulence, bloating and distension (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Gastrointestinal disorders large intestinal stenosis and obstruction (related to the mother)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Infections and infestations upper respiratory tract infections (related to the mother)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Infections and infestations urinary tract infections (related to the mother)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Infections and infestations viral infections (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Nervous system disorders central nervous system vascular disorders (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Nervous system disorders facial cranial nerve disorders (related to the mother)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Renal and urinary disorders renal obstructive disorders (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Renal and urinary disorders urinary tract signs and symptoms (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Injury, poisoning and procedural complications non-site specific injuries (related to the mother)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.20% 1/512 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) thyroid neoplasms malignant (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Vascular disorders peripheral embolism and thrombosis (related to the mother)	0.19% 1/518 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders cardiac septal defects congenital (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	2.3% 5/221 • Number of events 5 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	3.5% 7/201 • Number of events 7 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders cardiac disorders congenital NEC (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.90% 2/221 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	2.0% 4/201 • Number of events 4 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders persistant foetal circulation disorders (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.45% 1/221 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	2.0% 4/201 • Number of events 4 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders muskuloskeletal and connective tissue disorders of limbs congenital (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.90% 2/221 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders renal disorders congenital (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.90% 2/221 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders central nervous system disorder congenital NEC (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.45% 1/221 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders great vessel disorders congenital (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.50% 1/201 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders intestinal disorders congenital (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.45% 1/221 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders lymphatic system disorders congenital (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.45% 1/221 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders Non-site specific muscle disorders congenital (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.45% 1/221 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Congenital, familial and genetic disorders sex chromosomal abnormalities (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.45% 1/221 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Infections and infestations lower respiratory tract and lung infections (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.45% 1/221 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	3.5% 7/201 • Number of events 7 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Infections and infestations sepsis, bacteraemia, viraemia and fungaemia NEC (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	1.8% 4/221 • Number of events 4 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.50% 1/201 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Infections and infestations infections NEC (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.50% 1/201 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Infections and infestations respiratory syncytial viral infections (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.50% 1/201 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions gestational age and weight conditions (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	2.7% 6/221 • Number of events 6 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	1.5% 3/201 • Number of events 3 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions foetal complications NEC (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.45% 1/221 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	2.0% 4/201 • Number of events 4 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Pregnancy, puerperium and perinatal conditions foetal growth complications (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.50% 1/201 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Respiratory, thoracic and mediastinal disorders neonatal hypoxic conditions (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	2.7% 6/221 • Number of events 6 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	2.5% 5/201 • Number of events 6 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Respiratory, thoracic and mediastinal disorders pulmonary oedemas (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.90% 2/221 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.50% 1/201 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Respiratory, thoracic and mediastinal disorders breathing abnormalities (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.45% 1/221 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Respiratory, thoracic and mediastinal disorders respiratory failures (excl neonatal) (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.50% 1/201 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Cardiac disorders rate and rythm disorders NEC (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	1.8% 4/221 • Number of events 4 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.50% 1/201 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Cardiac disorders ischaemic coronary artery disorders (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.90% 2/221 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Nervous system disorders encephalopathies NEC (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.90% 2/221 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Nervous system disorders structural brain disorders NEC (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	1.00% 2/201 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Nervous system disorders hydrocephalic conditions (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.45% 1/221 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Investigations foetal and neonatal diagnostic procedures (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.90% 2/221 • Number of events 2 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.50% 1/201 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Blood and lymphatic system disorders coagulopathies (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.45% 1/221 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/201 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Gastrointestinal disorders colitis (excl infective) (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.50% 1/201 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)
Gastrointestinal disorders intestinal ulcers and perforation NEC (fetus/newborn)	0.00% 0/518 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/512 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.00% 0/221 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	0.50% 1/201 • Number of events 1 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)

Other adverse events

Measure	Dydrogesterone Tablets 3x10 mg (Maternal) n=518 participants at risk Dydrogesterone tablets 3x10 mg Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid	Crinone 8% Intravaginal Progesterone Gel 90 mg (Maternal) n=512 participants at risk Crinone 8% intravaginal progesterone gel 90 mg Intravaginal progesterone gel 90 mg OD	Dydrogesterone Tablets (Fetus/Newborn) n=221 participants at risk Maternal dosing of Dydrogesterone tablets 3x10 mg 221 subjects at risk=205 live births + 16 abortions/stillbirths	Crinone 8% Intravaginal Progesterone Gel (Fetus/Newborn) n=201 participants at risk Maternal dosing of Crinone 8% intravaginal progesterone gel 90 mg 201 subjects at risk = 188 live births + 13 abortions/stillbirths
Pregnancy, puerperium and perinatal conditions Vaginal haemorrhage	9.7% 50/518 • Number of events 50 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	6.8% 35/512 • Number of events 35 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	— 0/0 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 subjects in Micronized Progesterone)	— 0/0 • After signing of informed consent form until 30 days after birth, up to 11 months 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, 512 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