Skip to main content
OpenTrials
Completed

NCT Number: NCT00827632

Obesity, Oral Contraception, and Ovarian Suppression

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian Suppression Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose formulation

Drug

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.

Other names: Low dose

High dose formulation

Drug

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.

Other names: High dose

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Oral Contraception and Ovarian Suppression in Women With Different Weights

Acronym: 20/30

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 23, 2009
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.