A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

Hoffmann-La Roche18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteer

Interventions

AleglitazarDRUG

Multiple oral doses

Microgynon®DRUG

Multiple oral doses

PlaceboDRUG

Multiple oral doses

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Manchester, United Kingdom

Outcomes

Primary Outcomes

Pharmacokinetics of Levonorgestrel: area under the concentration time curve

Time frame: pre-dose and up to 24 hours post-dose

Pharmacokinetics of ethinyl estradiol: area under the concentration time curve

Time frame: pre-dose and up to 24 hours post-dose

Secondary Outcomes

Pharmacodynamics: luteinizing/follicular stimulation hormone concentration

Time frame: Days 1, 7, 13, 14, 15, 21

Safety: incidence of adverse events

Time frame: 16 weeks

Data from ClinicalTrials.gov

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