Oral Contraceptive Efficacy and Body Weight

Completed · Phase 4 · Has a placebo group

Conditions studied: Contraception, Body Weight

In brief

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.

Key facts

Study ID

NCT00662454

Run by

Oregon Health and Science University

People needed

120

Starts

2006-01-01

Expected to finish

2006-05-01

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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