Trial Outcomes & Findings for Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation (NCT NCT01044862)
NCT ID: NCT01044862
Last Updated: 2015-02-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
900 participants
Primary outcome timeframe
Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks
Results posted on
2015-02-02
Participant Flow
Participant milestones
| Measure |
Aromatase Inhibitors (AI)
A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
|
Clomiphene Citrate (CC)
CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
|
Follicle Stimulating Hormone (FSH)
A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
|
|---|---|---|---|
|
Overall Study
STARTED
|
299
|
300
|
301
|
|
Overall Study
COMPLETED
|
246
|
251
|
249
|
|
Overall Study
NOT COMPLETED
|
53
|
49
|
52
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
Baseline characteristics by cohort
| Measure |
Aromatase Inhibitors (AI)
n=299 Participants
A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
|
Clomiphene Citrate (CC)
n=300 Participants
CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
|
Follicle Stimulating Hormone (FSH)
n=301 Participants
A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
|
Total
n=900 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
32.0 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 4.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
299 Participants
n=5 Participants
|
300 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
900 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
299 participants
n=5 Participants
|
300 participants
n=7 Participants
|
301 participants
n=5 Participants
|
900 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeksOutcome measures
| Measure |
Aromatase Inhibitors (AI)
n=85 Participants
A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
|
Clomiphene Citrate (CC)
n=106 Participants
CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
|
Follicle Stimulating Hormone (FSH)
n=140 Participants
A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
|
|---|---|---|---|
|
Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH.
|
9 number of multiples
|
8 number of multiples
|
34 number of multiples
|
SECONDARY outcome
Timeframe: Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeksOutcome measures
| Measure |
Aromatase Inhibitors (AI)
n=299 Participants
A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
|
Clomiphene Citrate (CC)
n=300 Participants
CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
|
Follicle Stimulating Hormone (FSH)
n=301 Participants
A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
|
|---|---|---|---|
|
Rate of Pregnancy Obtained
|
85 participants
|
106 participants
|
140 participants
|
SECONDARY outcome
Timeframe: Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeksOutcome measures
| Measure |
Aromatase Inhibitors (AI)
n=299 Participants
A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
|
Clomiphene Citrate (CC)
n=300 Participants
CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
|
Follicle Stimulating Hormone (FSH)
n=301 Participants
A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
|
|---|---|---|---|
|
Time to Pregnancy
|
67.2 days
Standard Deviation 55.6
|
67.4 days
Standard Deviation 49.8
|
62.3 days
Standard Deviation 43.8
|
SECONDARY outcome
Timeframe: Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeksOutcome measures
| Measure |
Aromatase Inhibitors (AI)
n=299 Participants
A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
|
Clomiphene Citrate (CC)
n=300 Participants
CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
|
Follicle Stimulating Hormone (FSH)
n=301 Participants
A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
|
|---|---|---|---|
|
Live Birth Rate
|
56 participants
|
70 participants
|
97 participants
|
Adverse Events
Aromatase Inhibitors (AI)
Serious events: 11 serious events
Other events: 218 other events
Deaths: 0 deaths
Clomiphene Citrate (CC)
Serious events: 12 serious events
Other events: 214 other events
Deaths: 0 deaths
Follicle Stimulating Hormone (FSH)
Serious events: 25 serious events
Other events: 217 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aromatase Inhibitors (AI)
n=291 participants at risk
A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
|
Clomiphene Citrate (CC)
n=298 participants at risk
CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
|
Follicle Stimulating Hormone (FSH)
n=297 participants at risk
A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
|
|---|---|---|---|
|
Renal and urinary disorders
Presumed Pyelonephritis
|
0.00%
0/291
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.34%
1/297 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Reproductive system and breast disorders
Pyosalpinx Post IUI
|
0.00%
0/291
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.34%
1/297 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Gastrointestinal disorders
Cholecystitis
|
0.00%
0/291
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.34%
1/297 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Reproductive system and breast disorders
Ovarian Hyperstimulation Syndrome
|
0.00%
0/291
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.34%
1/297 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Reproductive system and breast disorders
Pain due to ovarian enlargement
|
0.00%
0/291
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.34%
1/297 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy of Unknown Location
|
0.00%
0/291
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.67%
2/298 • Number of events 2
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.34%
1/297 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Infections and infestations
Acute viral illness
|
0.00%
0/291
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.34%
1/297 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Injury, poisoning and procedural complications
Hemorrhagic Hematoma
|
0.34%
1/291 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/297
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
General disorders
Hospitalization for pain
|
0.00%
0/291
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.34%
1/297 • Number of events 2
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Gastrointestinal disorders
Hyperemesis
|
0.00%
0/291
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.67%
2/297 • Number of events 2
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Cardiac disorders
Hypertension
|
0.34%
1/291 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.34%
1/298 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/297
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Pregnancy, puerperium and perinatal conditions
Severe pre-eclampsia; HELLP syndrome, preterm labor
|
0.00%
0/291
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.34%
1/298 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/297
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Pregnancy, puerperium and perinatal conditions
Emergency C-section due to eclampsia
|
0.00%
0/291
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.34%
1/297 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization due to shorness of breath; pulmonary edema
|
0.34%
1/291 • Number of events 2
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/297
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Congenital, familial and genetic disorders
Congenital anomaly
|
0.69%
2/291 • Number of events 2
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
1.0%
3/298 • Number of events 3
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
1.0%
3/297 • Number of events 3
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
General disorders
Neonatal Death
|
0.34%
1/291 • Number of events 1
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/298
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
0.00%
0/297
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
1.7%
5/291 • Number of events 5
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
1.7%
5/298 • Number of events 5
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
3.7%
11/297 • Number of events 11
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
Other adverse events
| Measure |
Aromatase Inhibitors (AI)
n=291 participants at risk
A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
|
Clomiphene Citrate (CC)
n=298 participants at risk
CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
|
Follicle Stimulating Hormone (FSH)
n=297 participants at risk
A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Bloating
|
18.6%
54/291 • Number of events 54
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
16.8%
50/298 • Number of events 50
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
27.3%
81/297 • Number of events 81
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Reproductive system and breast disorders
Breast Pain
|
8.9%
26/291 • Number of events 26
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
6.4%
19/298 • Number of events 19
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
21.9%
65/297 • Number of events 65
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Gastrointestinal disorders
Constipation
|
2.7%
8/291 • Number of events 8
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
9.4%
28/298 • Number of events 28
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
2.0%
6/297 • Number of events 6
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Nervous system disorders
Headache
|
41.9%
122/291 • Number of events 122
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
34.9%
104/298 • Number of events 104
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
30.0%
89/297 • Number of events 89
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Endocrine disorders
Hot Flashes
|
16.8%
49/291 • Number of events 49
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
30.9%
92/298 • Number of events 92
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
8.4%
25/297 • Number of events 25
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
General disorders
Injection Site Reaction
|
3.1%
9/291 • Number of events 9
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
2.0%
6/298 • Number of events 6
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
10.8%
32/297 • Number of events 32
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
|
Musculoskeletal and connective tissue disorders
Joint/Limb pain
|
5.8%
17/291 • Number of events 17
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
2.7%
8/298 • Number of events 8
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
1.7%
5/297 • Number of events 5
The Numbers of Participants at Risk are different from the numbers provided in the Participant Flow module as not all subjects who were analyzed were administered study drug and therefore not all subjects were at risk for Adverse Events. Intent-to-treat analysis kept them in the study, but they had no AE risk.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place