Obesity, Oral Contraception, and Ovarian Suppression (20/30)

This study has been completed.

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Carolyn L. Westhoff, Columbia University

ClinicalTrials.gov Identifier:

NCT00827632

First received: January 21, 2009

Last updated: December 11, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 21, 2009

Last Updated Date

December 11, 2012

Start Date ^ICMJE

July 2006

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

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

Current Secondary Outcome Measures ^ICMJE

Possible Changes in Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users. [ Time Frame: Screening and follow-up 1 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Obesity, Oral Contraception, and Ovarian Suppression

Official Title ^ICMJE

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 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Ovarian Suppression

Intervention ^ICMJE

Drug: Low dose formulation
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.
Drug: High dose formulation
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.

Study Arm (s)

Active Comparator: Normal Weight group
Participants with a BMI of 19-24.9 kg/m^2
Interventions:
- Drug: Low dose formulation
- Drug: High dose formulation
Active Comparator: Obese group
Participants with a BMI of 30-39.9 kg/m^2
Interventions:
- Drug: Low dose formulation
- Drug: High dose formulation

Publications *

Westhoff CL, Torgal AH, Mayeda ER, Stanczyk FZ, Lerner JP, Benn EK, Paik M. Ovarian suppression in normal-weight and obese women during oral contraceptive use: a randomized controlled trial. Obstet Gynecol. 2010 Aug;116(2 Pt 1):275-83.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

226

Completion Date

December 2008

Primary Completion Date

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

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00827632

Other Study ID Numbers ^ICMJE

AAAB4823, R01HD045786

Has Data Monitoring Committee

Responsible Party

Carolyn L. Westhoff, Columbia University

Study Sponsor ^ICMJE

Columbia University

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Carolyn Westhoff, MD, MSc

Columbia University

Information Provided By

Columbia University

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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