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Oral Contraceptive Efficacy and Body Weight

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Oregon Clinical and Translational Research Institute
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00662454
First received: April 16, 2008
Last updated: August 3, 2011
Last verified: August 2011
History of Changes

April 16, 2008
August 3, 2011
January 2006
May 2006   (final data collection date for primary outcome measure)
Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts [ Time Frame: Approximately one year ] [ Designated as safety issue: No ]
Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00662454 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Oral Contraceptive Efficacy and Body Weight
Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure?

The purpose of the blood spot validation portion of the study is to test if measuring female hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two populations of oral contraceptive users: heavier and lighter women.

The blood spot validation portion of the study tests the hypothesis that progesterone assays from self-collected daily blood spots are equivalent to serum samples, and that the values obtained can identify women that ovulate. After validating collection methods, enrollment will begin for the feasibility portion of the study looking at thin and heavy women on birth control pills. All women in this portion of the study will take a very-low dose birth control pill that is normally available through a doctor's office. During each month of the study, women will have their blood pressure and weight recorded, and have their blood drawn twice per week or use a finger stick kit daily at home to check for the natural hormones and brain chemicals that tells if an egg develops. During the last week of each menstrual cycle (period week), women will also have their blood drawn to measure the levels of hormone found in the birth control pill. Women will also need to report in a written diary that they have taken their birth control pill for the day.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Contraception
  • Body Weight
Drug: ethinyl estradiol / levonorgestrel
Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.
Other Name: Alesse
  • Active Comparator: I
    10 normal weight women (BMI < 25 kg/m2)
    Intervention: Drug: ethinyl estradiol / levonorgestrel
  • Active Comparator: II
    10 obese women (BMI >30 kg/m2)
    Intervention: Drug: ethinyl estradiol / levonorgestrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 18 to 35
  • single baseline hematocrit ≥ 36%
  • single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to treatment with OCs.

Exclusion Criteria:

  • any absolute contraindications to ethinyl estradiol and levonorgestrel
  • smoking
  • actively seeking or involved in a weight loss program (must be weight stable)
  • pregnancy, breastfeeding, or seeking pregnancy
  • diagnosis of Polycystic Ovarian Syndrome
  • recent (8 week) use of OC (patch or ring included), intrauterine, or implantable hormonal contraception
  • DepoProvera use within six months
  • current use of drugs that interfere with metabolism of sex steroids.
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662454
OHSU FAMPLAN 0411, NIH R03 HD053611 01
Yes
Alison Edelman, MD, MPH, Oregon Health & Science University
Oregon Health and Science University
  • National Institutes of Health (NIH)
  • Oregon Clinical and Translational Research Institute
Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University
Oregon Health and Science University
August 2011

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