Obesity, Oral Contraception, and Ovarian Suppression - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 21, 2009

Last Updated Date

January 22, 2009

Start Date ^†

July 2006

Current Primary Outcome Measures ^†

The overall aim of the proposed study is to assess whether obese women may be at higher risk of hormonal contraceptive failure than normal weight women due to less contraceptive mediated suppression of ovarian function. [ Time Frame: Follow-up 1-8 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00827632 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

A secondary aim is to assess possible changes in lipid or carbohydrate metabolism in obese versus normal weight OC users. [ Time Frame: Screening and follow-up 1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Obesity, Oral Contraception, and Ovarian Suppression

Official Title ^†

Oral Contraception and Ovarian Suppression in Women With Different Weights

Brief 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 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 2029, 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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study

Condition ^†

Ovarian Suppression

Intervention ^†

Drug: Drug dosage: Portia and Lessina

Study Arms / Comparison Groups

Experimental: Participants are sorted into normal BMI (19-24.9) or obese BMI (30-39.9) groups.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

226

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Aged 18-35
BMI 19-24.9 or 30-39.9
Willing to take birth control pills for 3-4 months
Recent spontaneous pregnancy or cyclic menses

Exclusion Criteria:

Contraindications to hormonal contraceptives
Oophorectomy/PCOS
Taken OC's 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

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00827632

Responsible Party

Carolyn Westhoff, M.D., Columbia University

Secondary IDs ^††

RO1 HD04578601A2

Study Sponsor ^†

Columbia University

Collaborators ^††

National Institutes of Health (NIH)

Investigators ^†

Principal Investigator:

Carolyn Westhoff, MD, MSc

Columbia University

Information Provided By

Columbia University

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.