We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pregnancy in Polycystic Ovary Syndrome II (PPCOSII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00719186
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : June 9, 2014
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Pregnancy
Polycystic Ovary Syndrome
Interventions: Drug: Clomiphene citrate
Drug: Letrozole

  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

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 
Overall Participants Analyzed 
[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]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      376 100.0%      374 100.0%      750 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      376 100.0%      374 100.0%      750 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   376   374   750 


  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 ]


  Serious Adverse Events


  Other Adverse Events


  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

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Heping Zhang, Yale University
ClinicalTrials.gov Identifier: NCT00719186     History of Changes
Other Study ID Numbers: RMN-PPCOSII
First Submitted: July 17, 2008
First Posted: July 21, 2008
Results First Submitted: March 25, 2014
Results First Posted: June 9, 2014
Last Update Posted: October 30, 2017