Oral Contraceptive Efficacy and Body Weight

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborators: National Institutes of Health (NIH); Oregon Clinical and Translational Research Institute
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel; Polyestradiol phosphate

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.