A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the other period volunteers will receive placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Contraceptive Agents; Contraceptives, Oral; Ethinyl Estradiol-Norgestrel Combination; Ethinyl estradiol, levonorgestrel drug combination

Criteria

Inclusion Criteria:

• Healthy female volunteer, 18 to 45 years of age

• Body mass index (BMI) between 18.0 and 29.9 kg/m2

• Body weight at least 55.0 kg

• Non-pregnant, not lactating and not planning pregnancy from screening to 3 months after the last dose of study treatment

• Non-smoker for at least 3 months

Exclusion Criteria:

• Currently active gynecological disorder

• History of amenorrhea within the previous 3 years

• Known or suspected history of estrogen-dependent neoplasia or sex hormone-dependent malignant tumors

• Use of steroid hormone-containing intrauterine device (IUD) or progesterone-release IUD contraceptive within 3 months to screening.

• History of clinically significant disease that could jeopardize the volunteer safety in the study