Oral Contraceptive Efficacy and Body Weight

Phase 4

Completed

• Conditions: Contraception; Body Weight
• Interventions: Drug: ethinyl estradiol / levonorgestrel

• Registration Number: NCT00662454
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-21
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	ethinyl estradiol / levonorgestrel	10 normal weight women (BMI \< 25 kg/m2)
II	ethinyl estradiol / levonorgestrel	10 obese women (BMI \>30 kg/m2)

Primary Outcome Measures

Name	Time	Method
Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts	Approximately one year

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States