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A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01615354
First received: June 6, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  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: Placebo
Drug: Microgynon®
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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®

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of ethinyl estradiol: area under the concentration time curve [ Time Frame: pre-dose and up to 24 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamics: luteinizing/follicular stimulation hormone concentration [ Time Frame: Days 1, 7, 13, 14, 15, 21 ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01615354     History of Changes
Other Study ID Numbers: BP25559
Study First Received: June 6, 2012
Last Updated: May 7, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 19, 2013