Phase 4
Completed N=226
Obesity, Oral Contraception, and Ovarian Suppression
Ovarian Suppression
Source: ClinicalTrials.gov NCT00827632 ↗
Enrolled (actual)
226
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression. — 54; 28; 11; 12 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression. |
54; 28; 11; 12; 6; 6 | — |
| SECONDARY Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure). |
87.2; 90.2; 89.8; 92.7; 171.4; 177.0 | — |
| SECONDARY Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives. |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00827632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.