NCT01615354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

June 6, 2012

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Pharmacodynamics: luteinizing/follicular stimulation hormone concentration

    Days 1, 7, 13, 14, 15, 21

  • Safety: incidence of adverse events

    16 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Microgynon®Drug: Placebo

Treatment

EXPERIMENTAL
Drug: AleglitazarDrug: Microgynon®

Interventions

AleglitazarDRUG

Multiple oral doses

Treatment
Microgynon®DRUG

Multiple oral doses

PlaceboTreatment
PlaceboDRUG

Multiple oral doses

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Interventions

aleglitazarethinyl estradiol, levonorgestrel drug combination

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

GB(1)