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Obesity, Oral Contraception, and Ovarian Suppression (20/30)

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University
ClinicalTrials.gov Identifier:
NCT00827632
First received: January 21, 2009
Last updated: December 11, 2012
Last verified: December 2012
Results First Received: October 11, 2010  
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: Prevention
Condition: Ovarian Suppression
Interventions: Drug: Low dose formulation
Drug: High dose formulation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participant-related activities were conducted between July 2006-December 2008 in New York City

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible women were aged 18-35 years with a recent history of regular, spontaneous menstrual cycles, and agreed to use an Oral Contraceptive Pill (OCP) for 3 to 4 months and undergo eight biweekly study visits during the third or fourth OCP cycle.

Reporting Groups
  Description
Normal Weight Participants with a Body Mass Index (BMI) of 19-24.9.
Obese Participants with a Body Mass Index (BMI) of 30-39.9.

Participant Flow:   Overall Study
    Normal Weight   Obese
STARTED   128   98 
COMPLETED   106   75 
NOT COMPLETED   22   23 
Lost to Follow-up                8                12 
Early withdrawal                14                11 



  Baseline Characteristics
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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
Normal Weight Participants with a Body Mass Index (BMI) of 19-24.9.
Obese Participants with a Body Mass Index (BMI) of 30-39.9.
Total Total of all reporting groups

Baseline Measures
   Normal Weight   Obese   Total 
Overall Participants Analyzed 
[Units: Participants]
 106   75   181 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   106   75   181 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   106   75   181 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   19   19   38 
Non-Hispanic African American   30   23   53 
Non-Hispanic White   33   11   44 
Non-Hispanic Asian   14   1   15 
Non-compliant OCP users (dropped from analysis)   10   21   31 
Oral Contraceptive Pill Compliance 
[Units: Participants]
     
Consistent Users   96   54   150 
Inconsistent Users   4   9   13 
Nonusers   6   12   18 


  Outcome Measures

1.  Primary:   Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.   [ Time Frame: Up to 8 biweekly visits from start of OCP therapy ]

2.  Secondary:   Possible Changes in Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users.   [ Time Frame: Screening and follow-up 1 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.   [ Time Frame: 24 hours during week 3 of follow-up cycle ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Carolyn Westhoff
Organization: Columbia University
phone: 212-305-4805
e-mail: clw3@columbia.edu


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

Responsible Party: Carolyn L. Westhoff, Columbia University
ClinicalTrials.gov Identifier: NCT00827632     History of Changes
Other Study ID Numbers: AAAB4823
R01HD045786 ( US NIH Grant/Contract Award Number )
Study First Received: January 21, 2009
Results First Received: October 11, 2010
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board