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

This study has been completed.
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention Phase
Ovarian Suppression
Drug: Low dose formulation
Drug: High dose formulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Oral Contraception and Ovarian Suppression in Women With Different Weights

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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):

    1. no activity
    2. potential activity
    3. nonactive follicle-like structure
    4. active follicle-like structure
    5. luteinized unruptured follicle
    6. 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 Outcome Measures:
  • 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 ]

Enrollment: 226
Study Start Date: July 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal Weight group
Participants with a BMI of 19-24.9 kg/m^2
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.

Active Comparator: Obese group
Participants with a BMI of 30-39.9 kg/m^2
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.


  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827632

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Carolyn Westhoff, MD, MSc Columbia University
  More Information

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carolyn L. Westhoff, Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT00827632     History of Changes
Other Study ID Numbers: AAAB4823, R01HD045786
Study First Received: January 21, 2009
Results First Received: October 11, 2010
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Ovarian Suppression
Oral Contraceptives
Obese and Normal BMI

Additional relevant MeSH terms:
Vision, Low
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014