Phase 4 N=226 Randomized Quadruple-blind Prevention

Obesity, Oral Contraception, and Ovarian Suppression

Ovarian Suppression

Bottom Line

View on ClinicalTrials.gov: NCT00827632 ↗

Enrolled (actual)

226

Serious AEs

0.0%

Results posted

Jun 2011

Primary outcome: Primary: Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression. — 54; 28; 11; 12 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Low dose formulation (Drug); High dose formulation (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Columbia University
Primary completion: Dec 2008

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.	—	—

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.

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

View full record on ClinicalTrials.gov →

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.