A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01615354
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: Aleglitazar; Drug: Microgynon®; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• 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®
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics of Levonorgestrel: area under the concentration time curve [pre-dose and up to 24 hours post-dose]

2. Pharmacokinetics of ethinyl estradiol: area under the concentration time curve [pre-dose and up to 24 hours post-dose]

Secondary Outcome Measures

1. Pharmacodynamics: luteinizing/follicular stimulation hormone concentration [Days 1, 7, 13, 14, 15, 21]

2. Safety: incidence of adverse events [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1		Manchester		United Kingdom	M13 9WL

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01615354
• Other Study ID Numbers: BP25559
• First Posted: Jun 8, 2012
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination

Study Results

No Results Posted as of Nov 2, 2016