Status:
COMPLETED
Obesity, Oral Contraception, and Ovarian Suppression
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Ovarian Suppression
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
Brief Summary
This study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely...
Detailed Description
There is a large gap between lowest expected failure rates of about 1.5% and typical use failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral contraceptive (OC...
Eligibility Criteria
Inclusion
- Aged 18-35
- Body Mass Index (BMI) 19-24.9 or 30-39.9 kg/m\^2
- Willing to take birth control pills for 3-4 months
- Recent spontaneous pregnancy or cyclic menses
Exclusion
- Contraindications to hormonal contraceptives
- Oophorectomy/Polycystic ovary syndrome (PCOS)
- Taken oral contraceptives to regulate menses recently
- Weight reduction surgery
- Used Depo-Provera within the last 12 months
- Pregnant or currently breastfeeding
- Desiring pregnancy within the next 4 months
- Unable to make study visit commitment
- Previous participation in this study
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00827632
Start Date
July 1 2006
End Date
December 1 2008
Last Update
April 30 2019
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032