Trial Condition(s):

Premenstrual Dysphoric Disorder ( PMDD)

YAZ Premenstrual Dysphoric Disorder (PMDD) in China

Bayer Identifier:

91771

ClinicalTrials.gov Identifier:

NCT00824187

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

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

Trial Summary

Enrollment Goal
187
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Guangzhou, China, 510630

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510405

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100853

Status
Completed
 
Locations

Investigative Site

Jinan, China, 250012

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100050

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100191

Status
Completed
 
Locations

Investigative Site

Changsha, China, 410011

Status
Completed
 
Locations

Investigative Site

Wuhan, China, 430060

Status
Completed
 
Locations

Investigative Site

Xi'an, China, 710061

Status
Completed
 
Locations

Investigative Site

Kunming, China, 650032

Status
Completed
 
Locations

Investigative Site

Nanjing, China, 210029

Status
Completed
 
Locations

Investigative Site

Hangzhou, China, 310003

Status
Completed
 
Locations

Investigative Site

Xi'an, China, 710032

Status
Completed
 
Locations

Investigative Site

Tianjin, China, 300193

Status
Completed
 
Locations

Investigative Site

Dalian, China, 116011

Status
Completed
 
Locations

Investigative Site

Chengdu, China, 610041

Status
Completed
 

Trial Design