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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01297179
First received: February 15, 2011
Last updated: July 1, 2013
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Pharmacokinetics of Mirabegron
Drug: Mirabegron
Drug: Minidril
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Assessment of pharmacokinetics of Ethinyl estradiol (EE) and Levonorgestrel (LNG) by analysis of blood samples. [ Time Frame: Day 21 + Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of pharmacokinetics of mirabegron by analysis of blood samples. [ Time Frame: Day 21 + Day 49 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Mirabegron
    Oral
    Other Name: YM178
    Drug: Minidril
    Oral
    Other Names:
    • ethinyl estradiol
    • levonorgestrel
    Drug: Placebo
    Oral
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297179

Locations
France
Paris, France, 75015
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT01297179     History of Changes
Other Study ID Numbers: 178-CL-068, 2008-000216-32
Study First Received: February 15, 2011
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Astellas Pharma Inc:
Pharmacokinetics
Oral contraceptives
Drug interactions
Pharmacokinetics of mirabegron

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on July 20, 2014