Official Title: “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.

Study Type: Interventional

Study Design: Diagnostic, Open Label, Single Group Assignment

Study Primary Completion Date: May 2006

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.

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: I
  • 10 normal weight women (BMI < 25 kg/m2)
• Active Comparator: II
  • 10 obese women (BMI >30 kg/m2)

Primary Measures

• Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts
  • Time Frame: Completion of study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Oregon Health and Science University

Overall Clinical Trial Officials and Contacts

Alison Edelman, MD, MPH Principal Investigator Oregon Health and Science University  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00662454

Study ID Number: OHSU FAMPLAN 0411

ClinicalTrials.gov Identifier: NCT00662454

Health Authority: United States: Institutional Review Board

OHSU Women's Health Research Unit