Obesity, Oral Contraception, and Ovarian Suppression

Overview

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 Title of Study: “Oral Contraception and Ovarian Suppression in Women With Different Weights”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2008

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.

Interventions

  • Drug: Low dose formulation
    • Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use. Dose formula contains 20 ug of ethinyl estradiol (EE) and 100 ug of levonorgestrel (LN) per tablet.
  • Drug: High dose formulation
    • Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use. Dose formula contains 30 ug of ethinyl estradiol (EE) and 150 ug of levonorgestrel (LN) per tablet.

Arms, Groups and Cohorts

  • Active Comparator: Normal Weight group
    • Participants with a BMI of 19-24.9 kg/m^2
  • Active Comparator: Obese group
    • Participants with a BMI of 30-39.9 kg/m^2

Clinical Trial Outcome Measures

Primary Measures

  • Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.
    • Time Frame: 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): no activity potential activity nonactive follicle-like structure active follicle-like structure luteinized unruptured follicle 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Columbia University
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carolyn L. Westhoff, Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center – Columbia University
  • Overall Official(s)
    • Carolyn Westhoff, MD, MSc, Principal Investigator, Columbia University

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