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Completed

NCT Number: NCT01615354

A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Manchester, M13 9WL, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aleglitazar

Drug

Multiple oral doses

Microgynon®

Drug

Multiple oral doses

Placebo

Drug

Multiple oral doses

Primary outcomes

  1. Pharmacokinetics of Levonorgestrel: area under the concentration time curve

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

  2. Pharmacokinetics of ethinyl estradiol: area under the concentration time curve

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

Secondary outcomes

  1. Pharmacodynamics: luteinizing/follicular stimulation hormone concentration

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

  2. Safety: incidence of adverse events

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Single-Center, Randomized, Double-Blind, Placebo Controlled, Crossover Study to Assess the Effect of Aleglitazar on the Pharmacokinetics and Pharmacodynamics of Ethinyl Estradiol and Levonorgestrel as Components of the Oral Contraceptive Microgynon®

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 8, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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