Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pregnancy in Polycystic Ovary Syndrome II (PPCOSII)

This study has been completed.
Sponsor:
Collaborators:
Penn State University
University of Colorado, Denver
University of Michigan
University of Pennsylvania
The University of Texas Health Science Center at San Antonio
University of Vermont
Wayne State University
Information provided by (Responsible Party):
Heping Zhang, Yale University
ClinicalTrials.gov Identifier:
NCT00719186
First received: July 17, 2008
Last updated: May 12, 2014
Last verified: May 2014
Results First Received: March 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Pregnancy
Polycystic Ovary Syndrome
Interventions: Drug: Clomiphene citrate
Drug: Letrozole

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Arm A: Clomiphene Citrate     Arm B: Letrozole  
STARTED     376     374  
COMPLETED     376     374  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Arm A: Clomiphene Citrate     Arm B: Letrozole     Total  
Number of Participants  
[units: participants]
  376     374     750  
Age  
[units: years]
Mean ± Standard Deviation
  28.2  ± 4.0     28.9  ± 4.5     28.9  ± 4.3  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     376     374     750  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     376     374     750  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     376     374     750  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Live Birth   [ Time Frame: as few as 5 months, up to 16 months ]

2.  Secondary:   Number of Pregnancy   [ Time Frame: as few as 5 months, up to 16 months ]

3.  Secondary:   Number of Ovulations   [ Time Frame: as few as 5 months, up to 16 months ]

4.  Secondary:   Number of Serious Adverse Events   [ Time Frame: as few as 5 months, up to 16 months ]

5.  Secondary:   Neonatal Complication Rate   [ Time Frame: September 2008 - December 2011 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Heping Zhang
Organization: Yale University
phone: 203-785-5185
e-mail: rmn-dcc@panlists.yale.edu


No publications provided by Yale University

Publications automatically indexed to this study:

Responsible Party: Heping Zhang, Yale University
ClinicalTrials.gov Identifier: NCT00719186     History of Changes
Other Study ID Numbers: RMN-PPCOSII
Study First Received: July 17, 2008
Results First Received: March 25, 2014
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government