## Protocol Section
### Identification Module
**NCT ID:** NCT01297179

**Brief Title:** A Study to Evaluate the Possible Effects of Taking Mirabegron While Taking a Contraceptive Pill

**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)

#### Organization Study ID Info
**ID:** 178-CL-068
#### Organization
**Class:** INDUSTRY
**Full Name:** Astellas Pharma Inc
#### Secondary ID Infos
**ID:** 2008-000216-32
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2009-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-07-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-07-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-03

**Type:** ACTUAL

#### Start Date
**Date:** 2008-10

**Status Verified Date:** 2011-02

#### Study First Post Date
**Date:** 2011-02-16
**Type:** ESTIMATED
**Study First Submit Date:** 2011-02-15
**Study First Submit QC Date:** 2011-02-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Astellas Pharma Inc

#### Responsible Party

**Old Name Title:** Disclosure Office Europe

**Old Organization:** Astellas Pharma Europe BV

### Oversight Module

**Oversight Has DMC:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Healthy Volunteers

- Pharmacokinetics of Mirabegron

**Keywords:**

- Pharmacokinetics

- Oral contraceptives

- Drug interactions

- Pharmacokinetics of mirabegron

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Oral

**Name:** Mirabegron

**Other Names:**

- YM178

**Type:** DRUG

#### Intervention 2

**Description:** Oral

**Name:** Minidril

**Other Names:**

- ethinyl estradiol

- levonorgestrel

**Type:** DRUG

#### Intervention 3

**Description:** Oral

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Assessment of pharmacokinetics of Ethinyl estradiol (EE) and Levonorgestrel (LNG) by analysis of blood samples.

**Time Frame:** Day 21 + Day 29

#### Secondary Outcomes

**Measure:** Assessment of pharmacokinetics of mirabegron by analysis of blood samples.

**Time Frame:** Day 21 + Day 49

### Eligibility Module

**Eligibility 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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Paris

**Country:** France

**Zip:** 75015

#### Overall Officials

**Official 1:**

**Affiliation:** Astellas Pharma Europe B.V.

**Name:** Use Central Contact

**Role:** STUDY_DIRECTOR

### References Module

#### See Also Links

**Label:** Link to Results on JAPIC

**URL:** http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=640

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000004967

- Term: Estrogens

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000080066

- Term: Contraceptive Agents, Hormonal

- ID: D000003270

- Term: Contraceptive Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000003271

- Term: Contraceptive Agents, Female

- ID: D000003280

- Term: Contraceptives, Oral, Synthetic

- ID: D000003276

- Term: Contraceptives, Oral

- ID: D000003278

- Term: Contraceptives, Oral, Hormonal

- ID: D000058667

- Term: Adrenergic beta-3 Receptor Agonists

- ID: D000000318

- Term: Adrenergic beta-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000064804

- Term: Urological Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Urol

- Name: Urological Agents

### Intervention Browse Module - Browse Leaves

- ID: M8145

- Name: Ethinyl Estradiol

- Relevance: HIGH

- As Found: Iodine

- ID: M266279

- Name: Estradiol 17 beta-cypionate

- Relevance: LOW

- As Found: Unknown

- ID: M266280

- Name: Estradiol 3-benzoate

- Relevance: LOW

- As Found: Unknown

- ID: M8108

- Name: Estradiol

- Relevance: HIGH

- As Found: Cell lymphoma

- ID: M234941

- Name: Polyestradiol phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M19256

- Name: Levonorgestrel

- Relevance: HIGH

- As Found: SBRT

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M244406

- Name: Mirabegron

- Relevance: HIGH

- As Found: Acne

- ID: M6500

- Name: Contraceptives, Oral

- Relevance: LOW

- As Found: Unknown

- ID: M6501

- Name: Contraceptives, Oral, Combined

- Relevance: LOW

- As Found: Unknown

- ID: M8116

- Name: Estrogens

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M2116

- Name: Contraceptive Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M6495

- Name: Contraceptive Agents, Female

- Relevance: LOW

- As Found: Unknown

- ID: M6502

- Name: Contraceptives, Oral, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M29193

- Name: Adrenergic beta-3 Receptor Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3670

- Name: Adrenergic beta-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016912

- Term: Levonorgestrel

- ID: D000004997

- Term: Ethinyl Estradiol

- ID: C000520025

- Term: Mirabegron

- ID: D000004958

- Term: Estradiol

### Misc Info Module

- Version Holder: 2024-05-24
