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Oral Contraceptive Efficacy and Body Weight

Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception; Body Weight

Intervention: ethinyl estradiol / levonorgestrel (Drug); ethinyl estradiol / levonorgestrel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Oregon Health and Science University

Official(s) and/or principal investigator(s):
Alison Edelman, MD, MPH, Principal Investigator, Affiliation: Oregon Health and Science University

Summary

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.

Clinical Details

Official title: Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure?

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Oregon Health & Science University, Portland, Oregon 97239, United States
Additional Information

Starting date: January 2006
Last updated: August 3, 2011

Page last updated: August 23, 2015

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