Expired Study
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New York, New York 10032


Purpose:

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.


Study 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.


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


NCT ID:

NCT00827632


Primary Contact:

Principal Investigator
Carolyn Westhoff, MD, MSc
Columbia University


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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