A Study of Aleglitazar in Combination With Oral Contracep... | NCT01615354

Studies
A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

NCT01615354

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

Aleglitazar
Microgynon®
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Jun 6, 2012

First Submission Date that Met QC Criteria

Jun 6, 2012

First Posted Date

Jun 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Microgynon® Drug: Placebo
Treatment	Experimental		Drug: Aleglitazar Drug: Microgynon®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aleglitazar	Drug	Multiple oral doses	Treatment
Microgynon®

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Manchester		M13 9WL	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
C542437	aleglitazar
C072593	ethinyl estradiol, levonorgestrel drug combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided