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Obesity, Oral Contraception, and Ovarian Suppression

Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Suppression

Intervention: Low dose formulation (Drug); High dose formulation (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Columbia University

Official(s) and/or principal investigator(s):
Carolyn Westhoff, MD, MSc, Principal Investigator, Affiliation: Columbia University

Summary

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. We propose a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; we will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.

Clinical Details

Official title: Oral Contraception and Ovarian Suppression in Women With Different Weights

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

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

Secondary outcome:

Possible Changes in Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users.

Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

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 and Contacts

Columbia University Medical Center, New York, New York 10032, United States
Additional Information

Starting date: July 2006
Last updated: December 11, 2012

Page last updated: August 23, 2015

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