Clinical trial NCT00662454: Oral Contraceptive Efficacy and Body Weight
Official title: Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Body Weight
Keywords: contraceptive
efficacy
body weight
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Oregon Clinical and Translational Research Institute
First posted: 2008-04-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts
timeFrame: Approximately one year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison Edelman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: