YAZ Premenstrual Dysphoric Disorder (PMDD) in China

NCT ID: NCT00824187

Last Updated: 2014-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD).

Detailed Description

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Conditions

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Premenstrual Dysphoric Disorder ( PMDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

EE20/DRSP(YAZ, BAY86-5300)

Intervention Type DRUG

20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inert tablet

Interventions

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EE20/DRSP(YAZ, BAY86-5300)

20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd

Intervention Type DRUG

Placebo

Inert tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)

Exclusion Criteria

* Any formal psychotherapeutic counselling within 1 month before the screening visit (Visit 1) or used medication for Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD) including, but not limited to hormones, bromocriptine, GnRH agonists, vitamin B6 (\>100 mg), calcium supplements (\> 1500 mg/day), anxiolytics and antidepressants during the 3 month period prior to Visit 1
* Use of sleeping medication (including melatonin) for more than 3 days per month.
* Pregnancy or less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment
* Obesity (body mass index or BMI \> 30 kg/m2)
* Hypersensitivity to any ingredient of the study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Guangzhou, Guangdong, China

Site Status

Guangzhou, Guangdong, China

Site Status

Wuhan, Hubei, China

Site Status

Changsha, Hunan, China

Site Status

Nanjing, Jiangsu, China

Site Status

Dalian, Liaoning, China

Site Status

Jinan, Shandong, China

Site Status

Xi’an, Shanxi, China

Site Status

Xi’an, Shanxi, China

Site Status

Chengdu, Sichuan, China

Site Status

Kunming, Yunnan, China

Site Status

Hangzhou, Zhejiang, China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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311962

Identifier Type: OTHER

Identifier Source: secondary_id

91771

Identifier Type: -

Identifier Source: org_study_id

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