A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

November 1, 2016 updated by: Hoffmann-La Roche

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®

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Microgynon®
Multiple oral doses
Drug: Placebo
Multiple oral doses
EXPERIMENTAL: Treatment
Drug: Microgynon®
Multiple oral doses
Drug: Aleglitazar
Multiple oral doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of Levonorgestrel: area under the concentration time curve
Time Frame: pre-dose and up to 24 hours post-dose
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
pre-dose and up to 24 hours post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamics: luteinizing/follicular stimulation hormone concentration
Time Frame: Days 1, 7, 13, 14, 15, 21
Days 1, 7, 13, 14, 15, 21
Safety: incidence of adverse events
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (ESTIMATE)

June 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP25559

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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