Obesity, Oral Contraception, and Ovarian Suppression

Columbia University226 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

226

Conditions

Ovarian Suppression

Interventions

Low dose formulationDRUG

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.

High dose formulationDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.

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.

Time frame: Up to 8 biweekly visits from start of OCP therapy

Secondary Outcomes

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

Data from ClinicalTrials.gov

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