Status:
COMPLETED
YAZ Premenstrual Dysphoric Disorder (PMDD) in China
Lead Sponsor:
Bayer
Conditions:
Premenstrual Dysphoric Disorder ( PMDD)
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief 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
- Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00824187
Start Date
January 1 2009
End Date
January 1 2011
Last Update
April 2 2014
Active Locations (16)
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1
Guangzhou, Guangdong, China, 510405
2
Guangzhou, Guangdong, China, 510630
3
Wuhan, Hubei, China, 430060
4
Changsha, Hunan, China, 410011