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Obesity, Oral Contraception, and Ovarian Suppression (20/30)
This study has been completed.
First Received: January 21, 2009   Last Updated: January 22, 2009   History of Changes
Sponsors and Collaborators: Columbia University
National Institutes of Health (NIH)
Information provided by: Columbia University
ClinicalTrials.gov Identifier: NCT00827632
  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 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.


Condition Intervention Phase
Ovarian Suppression
Drug: Drug dosage: Portia and Lessina
Phase IV

MedlinePlus related topics: Birth Control Obesity
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: Oral Contraception and Ovarian Suppression in Women With Different Weights

Further study details as provided by Columbia University:

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 ]

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 ]

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
BMI group: Experimental
Participants are sorted into normal BMI (19-24.9) or obese BMI (30-39.9) groups.
Drug: Drug dosage: Portia and Lessina
Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, USP .15 mg/.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP .1 mg/.02 mg) for 3 months use.

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827632

Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Carolyn Westhoff, MD, MSc Columbia University
  More Information

No publications provided

Responsible Party: Columbia University ( Carolyn Westhoff, M.D. )
Study ID Numbers: AAAB4823, RO1 HD04578601A2
Study First Received: January 21, 2009
Last Updated: January 22, 2009
ClinicalTrials.gov Identifier: NCT00827632     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Body Weight
Obesity
Contraceptive Agents
Levonorgestrel
Estradiol 3-benzoate
Contraceptives, Oral
Estradiol valerate
Ethinyl Estradiol
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol

ClinicalTrials.gov processed this record on May 06, 2009