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

Columbia University

Status and phase: Completed; Phase 4

Conditions: Ovarian Suppression

Treatments: Drug: Low dose formulation; Drug: High dose formulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00827632

R01HD045786 (U.S. NIH Grant/Contract)

AAAB4823

Details and patient eligibility

About

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.

Full 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) effectiveness in population subgroups. Recent reports suggest greater OC failure among heavier women, particularly those using the lowest doses. The prevalence of obesity in the US population has recently increased to about 23% in women aged 20-29, peak years for OC use. OC physiology and effectiveness have not been evaluated in obese women.

Enrollment: 226 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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226 participants in 2 patient groups

Normal Weight group

Active Comparator group

Description:

Participants with a BMI of 19-24.9 kg/m\^2

Treatment:

Drug: High dose formulation

Drug: Low dose formulation

Obese group

Active Comparator group

Description:

Participants with a BMI of 30-39.9 kg/m\^2

Treatment:

Drug: High dose formulation

Drug: Low dose formulation