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Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome (PCOS)

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ClinicalTrials.gov Identifier: NCT01607320
Recruitment Status : Terminated (Over budget, slow recruitment, and personnel change)
First Posted : May 30, 2012
Results First Posted : June 1, 2015
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce Lessey, Prisma Health-Upstate

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Polycystic Ovarian Syndrome
Interventions Drug: Raloxifene
Drug: Clomiphene
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Raloxifene Clomiphene
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 0 [1] 0 [1]
Completed 0 [2] 0 [1]
Not Completed 0 0
[1]
The study was randomized between the two treatments and was never unblinded,therefore unknown.
[2]
The study was randomized between the 2 treatments and was never unblinded,so unknown.
Arm/Group Title All Study Participants
Hide Arm/Group Description 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
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
3
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  33.3%
White
2
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Pregnancy
Hide Description 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.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was randomized between the two treatments and was never unblinded, therefore randomization is unknown and data collection is incomplete.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Ovulation
Hide Description If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.
Time Frame Cycle day 22-24
Hide Outcome Measure Data
Hide Analysis Population Description
Data collected could not be analyzed as it was never unblended and randomization is unknown.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide Arm/Group Description The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Study Participants
Affected / at Risk (%)
Total   2/3 (66.67%) 
General disorders   
headache [1]  1/3 (33.33%) 
Infections and infestations   
head cold [2]  1/3 (33.33%) 
[1]
pt 3 experienced headace noted at visit 3
[2]
pt 2 experienced head cold at visit 6
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bruce Lessey
Organization: Greenville Health System
Phone: 864-455-1600
EMail: blessey@ghs.org
Layout table for additonal information
Responsible Party: Bruce Lessey, Prisma Health-Upstate
ClinicalTrials.gov Identifier: NCT01607320    
Other Study ID Numbers: 9469
First Submitted: February 15, 2012
First Posted: May 30, 2012
Results First Submitted: April 14, 2015
Results First Posted: June 1, 2015
Last Update Posted: September 20, 2018