Trial Outcomes & Findings for Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome (NCT NCT01607320)
NCT ID: NCT01607320
Last Updated: 2018-09-20
Results Overview
Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.
TERMINATED
NA
3 participants
4 months
2018-09-20
Participant Flow
Participant milestones
| Measure |
Raloxifene
3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7
Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal
|
Clomiphene
3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7
Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome
Baseline characteristics by cohort
| Measure |
All Study Participants
n=3 Participants
Participants were randomized to receive one of the two following interventions, but the study was terminated and data will not be unblinded: 1) 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 with Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal; or 2) 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 with Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: The study was randomized between the two treatments and was never unblinded, therefore randomization is unknown and data collection is incomplete.
Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle day 22-24Population: Data collected could not be analyzed as it was never unblended and randomization is unknown.
If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.
Outcome measures
Outcome data not reported
Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Study Participants
n=3 participants at risk
The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
|
|---|---|
|
General disorders
headache
|
33.3%
1/3
|
|
Infections and infestations
head cold
|
33.3%
1/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place