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A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01615354
First Posted: June 8, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Healthy Volunteer Drug: Aleglitazar Drug: Microgynon® Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official 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®

Further study details as provided by Hoffmann-La Roche:

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

Enrollment: 18
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Microgynon®
Multiple oral doses
Drug: Placebo
Multiple oral doses
Experimental: Treatment Drug: Aleglitazar
Multiple oral doses
Drug: Microgynon®
Multiple oral doses

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615354


Locations
United Kingdom
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01615354     History of Changes
Other Study ID Numbers: BP25559
First Submitted: June 6, 2012
First Posted: June 8, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Contraceptive Agents
Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol-Norgestrel Combination
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital