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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01297179
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : July 3, 2013
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Pharmacokinetics of Mirabegron Drug: Mirabegron Drug: Minidril Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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)
Study Start Date : October 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Mirabegron
    Other Name: YM178
  • Drug: Minidril
    Other Names:
    • ethinyl estradiol
    • levonorgestrel
  • Drug: Placebo

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

Secondary Outcome Measures :
  1. Assessment of pharmacokinetics of mirabegron by analysis of blood samples. [ Time Frame: Day 21 + Day 49 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01297179

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Paris, France, 75015
Sponsors and Collaborators
Astellas Pharma Inc
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Study Director: Use Central Contact Astellas Pharma Europe B.V.
Additional Information:
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Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV Identifier: NCT01297179    
Other Study ID Numbers: 178-CL-068
2008-000216-32 ( EudraCT Number )
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: February 2011
Keywords provided by Astellas Pharma Inc:
Oral contraceptives
Drug interactions
Pharmacokinetics of mirabegron
Additional relevant MeSH terms:
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Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents