Trial Outcomes & Findings for Pregnancy in Polycystic Ovary Syndrome II (NCT NCT00719186)
NCT ID: NCT00719186
Last Updated: 2018-06-14
Results Overview
The primary outcome measure is the occurrence of a live birth during the study period. Safety measures will be the number and type of reported adverse events in subjects and offspring.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
750 participants
Primary outcome timeframe
as few as 5 months, up to 16 months
Results posted on
2018-06-14
Participant Flow
Participant milestones
| Measure |
Arm A: Clomiphene Citrate
Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
Arm B: Letrozole
Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
376
|
374
|
|
Overall Study
COMPLETED
|
376
|
374
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pregnancy in Polycystic Ovary Syndrome II
Baseline characteristics by cohort
| Measure |
Arm A: Clomiphene Citrate
n=376 Participants
Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
Arm B: Letrozole
n=374 Participants
Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
Total
n=750 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 4.0 • n=99 Participants
|
28.9 years
STANDARD_DEVIATION 4.5 • n=107 Participants
|
28.9 years
STANDARD_DEVIATION 4.3 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
376 Participants
n=99 Participants
|
374 Participants
n=107 Participants
|
750 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
376 Participants
n=99 Participants
|
374 Participants
n=107 Participants
|
750 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
376 Participants
n=99 Participants
|
374 Participants
n=107 Participants
|
750 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: as few as 5 months, up to 16 monthsThe primary outcome measure is the occurrence of a live birth during the study period. Safety measures will be the number and type of reported adverse events in subjects and offspring.
Outcome measures
| Measure |
Arm A: Clomiphene Citrate
n=376 Participants
Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
Arm B: Letrozole
n=374 Participants
Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
|---|---|---|
|
Live Birth
|
72 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: as few as 5 months, up to 16 monthsOutcome measures
| Measure |
Arm A: Clomiphene Citrate
n=376 Participants
Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
Arm B: Letrozole
n=374 Participants
Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
|---|---|---|
|
Number of Pregnancy
|
103 Participants
|
154 Participants
|
SECONDARY outcome
Timeframe: as few as 5 months, up to 16 monthsOutcome measures
| Measure |
Arm A: Clomiphene Citrate
n=376 Participants
Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
Arm B: Letrozole
n=374 Participants
Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
|---|---|---|
|
Number of Ovulations
|
331 ovulations
|
388 ovulations
|
SECONDARY outcome
Timeframe: as few as 5 months, up to 16 monthsOutcome measures
| Measure |
Arm A: Clomiphene Citrate
n=376 Participants
Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
Arm B: Letrozole
n=374 Participants
Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
|---|---|---|
|
Number of Serious Adverse Events
|
13 events
|
22 events
|
SECONDARY outcome
Timeframe: September 2008 - December 2011Population: Neonatal complications reported per infant, an infant could have more than one complication.
Outcome measures
| Measure |
Arm A: Clomiphene Citrate
n=66 Participants
Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
Arm B: Letrozole
n=102 Participants
Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
|---|---|---|
|
Neonatal Complication Rate
Neonatal jaundice
|
17 participants
|
27 participants
|
|
Neonatal Complication Rate
Neonatal respiratory distress syndrome
|
2 participants
|
7 participants
|
|
Neonatal Complication Rate
Neonatal hospitalization >3 days
|
4 participants
|
4 participants
|
|
Neonatal Complication Rate
Intrauterine growth restriction
|
1 participants
|
5 participants
|
|
Neonatal Complication Rate
Neonatal infectin
|
2 participants
|
2 participants
|
|
Neonatal Complication Rate
Minor birth defect
|
0 participants
|
1 participants
|
|
Neonatal Complication Rate
Other complication
|
4 participants
|
5 participants
|
|
Neonatal Complication Rate
Congenital anomaly
|
1 participants
|
4 participants
|
|
Neonatal Complication Rate
Neonatal death
|
2 participants
|
1 participants
|
Adverse Events
Arm A: Clomiphene Citrate
Serious events: 13 serious events
Other events: 283 other events
Deaths: 0 deaths
Arm B: Letrozole
Serious events: 21 serious events
Other events: 285 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Clomiphene Citrate
n=355 participants at risk；n=376 participants at risk
Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
Arm B: Letrozole
n=359 participants at risk；n=374 participants at risk
Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
|---|---|---|
|
Reproductive system and breast disorders
Ovarian torsion
|
0.27%
1/376 • 4 years
|
0.00%
0/374 • 4 years
|
|
Reproductive system and breast disorders
Ectopic Pregnancy
|
0.80%
3/376 • 4 years
|
1.1%
4/374 • 4 years
|
|
Reproductive system and breast disorders
Ruptured Corpus Luteum Cyst
|
0.00%
0/376 • 4 years
|
0.27%
1/374 • 4 years
|
|
Skin and subcutaneous tissue disorders
Carcinoma of the Skin-stage 3
|
0.27%
1/376 • 4 years
|
0.00%
0/374 • 4 years
|
|
Hepatobiliary disorders
cholecystectomy
|
0.27%
1/376 • 4 years
|
0.27%
1/374 • 4 years
|
|
Reproductive system and breast disorders
Heterotopic Pregnancy
|
0.27%
1/376 • 4 years
|
0.00%
0/374 • 4 years
|
|
Reproductive system and breast disorders
Pregnancy of Unknown Location
|
0.27%
1/376 • 4 years
|
0.27%
1/374 • 4 years
|
|
Gastrointestinal disorders
Appendectomy
|
0.00%
0/376 • 4 years
|
0.27%
1/374 • 4 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/376 • 4 years
|
0.27%
1/374 • 4 years
|
|
Renal and urinary disorders
Mid ureteral stone
|
0.00%
0/376 • 4 years
|
0.27%
1/374 • 4 years
|
|
Congenital, familial and genetic disorders
Congenital Anomaly
|
0.27%
1/376 • 4 years
|
1.1%
4/374 • 4 years
|
|
Pregnancy, puerperium and perinatal conditions
Fetal Demise
|
0.27%
1/376 • 4 years
|
0.27%
1/374 • 4 years
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal death
|
0.53%
2/376 • 4 years
|
0.27%
1/374 • 4 years
|
|
General disorders
Hospitalization
|
0.80%
3/376 • 4 years
|
1.3%
5/374 • 4 years
|
Other adverse events
| Measure |
Arm A: Clomiphene Citrate
n=355 participants at risk；n=376 participants at risk
Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
Arm B: Letrozole
n=359 participants at risk；n=374 participants at risk
Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
|
|---|---|---|
|
Nervous system disorders
Headache
|
47.9%
170/355 • 4 years
|
46.5%
167/359 • 4 years
|
|
Musculoskeletal and connective tissue disorders
abdominal/pelvic pain
|
38.9%
138/355 • 4 years
|
40.7%
146/359 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
25.6%
91/355 • 4 years
|
30.6%
110/359 • 4 years
|
|
Endocrine disorders
Hot flashes
|
33.0%
117/355 • 4 years
|
20.3%
73/359 • 4 years
|
|
Reproductive system and breast disorders
Breast pain
|
21.4%
76/355 • 4 years
|
21.2%
76/359 • 4 years
|
|
General disorders
Fatigue
|
14.9%
53/355 • 4 years
|
21.7%
78/359 • 4 years
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
18.0%
64/355 • 4 years
|
16.7%
60/359 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.5%
55/355 • 4 years
|
17.8%
64/359 • 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
17.5%
62/355 • 4 years
|
12.5%
45/359 • 4 years
|
|
Gastrointestinal disorders
Abdominal bloating
|
11.8%
42/355 • 4 years
|
13.6%
49/359 • 4 years
|
|
Psychiatric disorders
Agitation
|
10.4%
37/355 • 4 years
|
12.0%
43/359 • 4 years
|
|
Nervous system disorders
Dizziness
|
7.6%
27/355 • 4 years
|
12.3%
44/359 • 4 years
|
|
Infections and infestations
Upper respiratory infection
|
8.7%
31/355 • 4 years
|
10.6%
38/359 • 4 years
|
|
Psychiatric disorders
Irritability
|
9.3%
33/355 • 4 years
|
9.2%
33/359 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Joint/limb pain
|
7.3%
26/355 • 4 years
|
9.2%
33/359 • 4 years
|
|
Infections and infestations
Flu like symptoms
|
5.1%
18/355 • 4 years
|
8.1%
29/359 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
18/355 • 4 years
|
6.7%
24/359 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
20/355 • 4 years
|
5.8%
21/359 • 4 years
|
|
Skin and subcutaneous tissue disorders
Acne/ oily skin
|
6.8%
24/355 • 4 years
|
4.5%
16/359 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
5.6%
20/355 • 4 years
|
4.7%
17/359 • 4 years
|
|
Reproductive system and breast disorders
Abnormal vaginal bleeding
|
2.5%
9/355 • 4 years
|
5.0%
18/359 • 4 years
|
|
Psychiatric disorders
Insomnia
|
3.9%
14/355 • 4 years
|
3.3%
12/359 • 4 years
|
|
Infections and infestations
Vaginal infection
|
4.5%
16/355 • 4 years
|
2.2%
8/359 • 4 years
|
|
Infections and infestations
Allergic rhinitis
|
3.4%
12/355 • 4 years
|
2.8%
10/359 • 4 years
|
|
Infections and infestations
fever
|
2.5%
9/355 • 4 years
|
3.6%
13/359 • 4 years
|
|
Infections and infestations
Urinary tract infection
|
2.8%
10/355 • 4 years
|
3.3%
12/359 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
9/355 • 4 years
|
2.8%
10/359 • 4 years
|
|
Psychiatric disorders
Depression
|
2.8%
10/355 • 4 years
|
1.7%
6/359 • 4 years
|
|
Renal and urinary disorders
Urinary frequency
|
2.3%
8/355 • 4 years
|
1.9%
7/359 • 4 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.1%
4/355 • 4 years
|
2.5%
9/359 • 4 years
|
|
Eye disorders
Blurred vision
|
1.1%
4/355 • 4 years
|
2.2%
8/359 • 4 years
|
|
General disorders
Chills
|
2.3%
8/355 • 4 years
|
1.1%
4/359 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus complaints
|
1.1%
4/355 • 4 years
|
2.2%
8/359 • 4 years
|
|
General disorders
First Trimester other complication during pregnancy
|
2.3%
8/355 • 4 years
|
4.2%
15/359 • 4 years
|
|
Pregnancy, puerperium and perinatal conditions
Second Trimester Hyperemesis
|
1.4%
5/355 • 4 years
|
2.2%
8/359 • 4 years
|
|
Pregnancy, puerperium and perinatal conditions
Second Trimester Gestational Diabetes
|
3.7%
13/355 • 4 years
|
7.5%
27/359 • 4 years
|
|
Pregnancy, puerperium and perinatal conditions
Second Trimester Pre-eclampsia/ eclampsia
|
3.7%
13/355 • 4 years
|
5.0%
18/359 • 4 years
|
|
Pregnancy, puerperium and perinatal conditions
Second Trimester pretem labor
|
3.4%
12/355 • 4 years
|
3.9%
14/359 • 4 years
|
|
Pregnancy, puerperium and perinatal conditions
Second Trimester Premature rupture of membrane
|
2.0%
7/355 • 4 years
|
2.2%
8/359 • 4 years
|
|
Pregnancy, puerperium and perinatal conditions
Second Trimester Incompetant cervix
|
1.7%
6/355 • 4 years
|
2.2%
8/359 • 4 years
|
|
Pregnancy, puerperium and perinatal conditions
Post-partum hemorrhage
|
0.85%
3/355 • 4 years
|
2.2%
8/359 • 4 years
|
|
Infections and infestations
Post-partum Infection
|
0.56%
2/355 • 4 years
|
1.9%
7/359 • 4 years
|
|
Hepatobiliary disorders
Neonatal Jaundice
|
4.8%
17/355 • 4 years
|
7.5%
27/359 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.56%
2/355 • 4 years
|
1.9%
7/359 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place