YAZ Premenstrual Dysphoric Disorder (PMDD) in China

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Contraceptive Agents; Contraceptives, Oral; Drospirenone; Ethinyl Estradiol

Criteria

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