YAZ Premenstrual Dysphoric Disorder (PMDD) in China

Last updated: April 1, 2014
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Severe Premenstrual Symptom

Premenstrual Syndrome

Treatment

N/A

Clinical Study ID

NCT00824187
91771
311962
  • Ages 18-45
  • Female

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Any formal psychotherapeutic counselling within 1 month before the screening visit (Visit 1) or used medication for Premenstrual Syndrome (PMS) or Premenstrual DysphoricDisorder (PMDD) including, but not limited to hormones, bromocriptine, GnRH agonists,vitamin B6 (>100 mg), calcium supplements (> 1500 mg/day), anxiolytics andantidepressants 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 beforestart of treatment

  • Obesity (body mass index or BMI > 30 kg/m2)

  • Hypersensitivity to any ingredient of the study drug

Study Design

Total Participants: 187
Study Start date:
January 01, 2009
Estimated Completion Date:
January 31, 2011

Connect with a study center

  • Guangzhou, Guangdong 510405
    China

    Site Not Available

  • Wuhan, Hubei 430060
    China

    Site Not Available

  • Changsha, Hunan 410011
    China

    Site Not Available

  • Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Dalian, Liaoning 116011
    China

    Site Not Available

  • Jinan, Shandong 250012
    China

    Site Not Available

  • Xi'an, Shanxi 710032
    China

    Site Not Available

  • Chengdu, Sichuan 610041
    China

    Site Not Available

  • Kunming, Yunnan 650032
    China

    Site Not Available

  • Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Beijing, 100191
    China

    Site Not Available

  • Tianjin, 300193
    China

    Site Not Available

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