Clinical Trial: YAZ Premenstrual Dysphoric Disorder (PMDD) in China

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Monophasic Oral Contraceptive YAZ (20 µg Ethinylestradiol, 3 mg Drospirenone) in the Treatment of Chinese Patients With

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).

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: The difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days before menses of the 3rd cycle in the treatment phase to average scores from the last 5 days before menses of the 2 run in cycles [ Time Frame: 3 cycles (1 cycle= 28 days) ]

Original Primary Outcome: The primary efficacy variable is the difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days of the 3rd treatment cycle to average scores from the last 5 days of the 2 run in cycles [ Time Frame: 3 cycles (1 cycle= 28 days) ]

Current Secondary Outcome:

  • The difference in DRSP scale scores for the 3 functional impairment items, comparing the average over the last 5 days of daily scores from the 3rd cycle in the treatment phase to the average of daily scores from the 2 run in cycles [ Time Frame: 3 cycles ]
  • Descriptive statistics for total DRSP scale scores (sum of the first 21 items) of the last 5 days for each of the 2 run in cycles, each of the 3 cycles in the treatment phase, and the average of the 3 cycles in the treatment phase [ Time Frame: 3 cylces ]
  • Descriptive statistics for change in total DRSP scale scores (sum of the first 21 items) of the last 5 days from baseline to each cycle in the treatment phase and to the average of the 3 cycles in the treatment phase [ Time Frame: 3 cycles ]
  • Assessment of CGI scores [ Time Frame: 3 cycles ]
  • Adverse events [ Time Frame: Whole study period ]
  • Laboratory tests [ Time Frame: Whole study period ]


Original Secondary Outcome:

  • Descriptive statistics for total DRSP scale scores for each of the 2 run cycles, each of the 3 treatment cycles, and the average of the 3 treatment cycles [ Time Frame: 3 cycles ]
  • Difference in DRSP scale scores for the 3 functional impairment items, comparing the average of daily scores from the 3rd treatment cycle to the average of daily scores from the 2 run in cycles [ Time Frame: 3 cylces ]
  • Assessment of CGI scores [ Time Frame: 3 cycles ]
  • Adverse events [ Time Frame: Whole study period ]
  • Laboratory tests [ Time Frame: Whole study period ]


Information By: Bayer

Dates:
Date Received: January 15, 2009
Date Started: January 2009
Date Completion:
Last Updated: April 1, 2014
Last Verified: April 2014