A Study to Evaluate the Possible Effects of Taking Mirabegron While Taking a Contraceptive Pill

July 1, 2013 updated by: Astellas Pharma Inc

A Double-blind Two-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics (PK) of an Ethinyl Estradiol and Levonorgestrel Containing Combined Oral Contraceptive (COC)

The objective of this study is to determine the effect of multiple doses of mirabegron on the pharmacokinetics of an oral contraceptive.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Paris, France, 75015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Subjects above 35 years inclusive are re-evaluated for the risks of using of a COC
Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
On oral contraceptive with 30ʯg ethinyl estradiol (EE) plus either 125ʯg or 150ʯg levonorgestrel (LNG) for at least three months prior to date of randomization and well tolerated
During the study the subject is willing to use 1 of the 3 following contraceptive methods: diaphragm with spermicide, intrauterine device or partner is using condoms in combination with a spermicidal cream

Exclusion Criteria:

Subjects will be excluded from participation if any of the following apply:

Known or suspected hypersensitivity to YM178 or any components of the formulation used
Pregnant or breast feeding within 6 months before screening assessment
Any of the liver function tests (i.e. ALT, AST and Alkaline phosphatase) above the upper limit of normal
Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active Hay-fever)
Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
A marked baseline prolongation of QT/QTc interval after repeated measurements of >450 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day)
Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit
Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit
History of drinking more than 14 units of alcohol per week (1 unit = 270 cc of beer or 40 cc of spirits or 1 glass of wine) within 3 months prior to admission to the Clinical Unit
Positive test for drugs of abuse or positive alcohol test on the day of admission into the clinical unit
History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Clinical Unit
Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study
Donation of blood or blood products within 3 months prior to admission to the Clinical Unit
Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2
Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason
Unwillingness to use additional barrier contraceptive methods for the course of the study and for one month after the end of study visit
Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of pharmacokinetics of Ethinyl estradiol (EE) and Levonorgestrel (LNG) by analysis of blood samples. Time Frame: Day 21 + Day 29	Day 21 + Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of pharmacokinetics of mirabegron by analysis of blood samples. Time Frame: Day 21 + Day 49	Day 21 + Day 49

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Link to Results on JAPIC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria