Overview
Obesity, Oral Contraception, and Ovarian Suppression
Status:
Completed
Completed
Trial end date:
2008-12-01
2008-12-01
Target enrollment:
0
0
Participant gender:
Female
Female
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 used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Columbia UniversityCollaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Treatments:
Ethinyl Estradiol
Criteria
Inclusion Criteria:- 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 Criteria:
- 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