Oral Contraceptive Efficacy and Body Weight

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

Sponsors

Lead Sponsor: Oregon Health and Science University

Collaborator: National Institutes of Health (NIH)
Oregon Clinical and Translational Research Institute

Source Oregon Health and Science University
Brief 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.

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.

Overall Status Completed
Start Date January 2006
Completion Date May 2006
Primary Completion Date May 2006
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts Approximately one year
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: ethinyl estradiol / levonorgestrel

Description: 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.

Arm Group Label: I

Other Name: Alesse

Intervention Type: Drug

Intervention Name: ethinyl estradiol / levonorgestrel

Description: 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.

Arm Group Label: II

Other Name: Alesse

Eligibility

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.

Gender: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Alison Edelman, MD, MPH Principal Investigator Oregon Health and Science University
Location
Facility: Oregon Health & Science University
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Oregon Health and Science University

Investigator Full Name: Alison Edelman

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: I

Type: Active Comparator

Description: 10 normal weight women (BMI < 25 kg/m2)

Label: II

Type: Active Comparator

Description: 10 obese women (BMI >30 kg/m2)

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov