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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

January 21, 2009
December 11, 2012
July 2006
December 2008   (final data collection date for primary outcome measure)
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.

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 ]
Complete list of historical versions of study NCT00827632 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ]
Not Provided
Not Provided
 
Obesity, Oral Contraception, and Ovarian Suppression
Oral Contraception and Ovarian Suppression in Women With Different Weights

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Ovarian Suppression
  • 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: 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
226
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00827632
AAAB4823, R01HD045786
No
Carolyn L. Westhoff, Columbia University
Columbia University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Carolyn Westhoff, MD, MSc Columbia University
Columbia University
December 2012

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