Obesity, Oral Contraception, and Ovarian Suppression

Phase 4

Completed

• Conditions: Ovarian Suppression
• Interventions: Drug: Low dose formulation; Drug: High dose formulation

• Registration Number: NCT00827632
• Lead Sponsor: Columbia University

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 used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.

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) 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.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-22
• Study First Posted: 2009-01-23
• Results First Submitted: 2010-10-11
• Results First Submitted QC: 2011-05-16
• Results First Posted: 2011-06-14
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Weight group	High dose formulation	Participants with a BMI of 19-24.9 kg/m\^2
Obese group	Low dose formulation	Participants with a BMI of 30-39.9 kg/m\^2
Normal Weight group	Low dose formulation	Participants with a BMI of 19-24.9 kg/m\^2
Obese group	High dose formulation	Participants with a BMI of 30-39.9 kg/m\^2

Primary Outcome Measures

Name	Time	Method
Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.	Up to 8 biweekly visits from start of OCP therapy	Perpendicular diameter, ethinyl estradiol, and progesterone values were used to create Hoogland Scores. Hoogland Scores were used to assess ovarian suppression during OC use. The Hoogland Score comprises 6 grades (Because of small numbers, grades 5 and 6 were combined): 1. no activity; 2. potential activity; 3. nonactive follicle-like structure; 4. active follicle-like structure; 5. luteinized unruptured follicle; 6. ovulation; Each participant received a score from 1-6 to indicate the level of ovarian suppression; total number of participants were tallied for each Hoogland score.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.	24 hours during week 3 of follow-up cycle
Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).	Screening (baseline) and follow-up 1 (exit)

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States