check_circleStudy Completed

Premenstrual Dysphoric Disorder ( PMDD)

Bayer Identifier:

91771

ClinicalTrials.gov Identifier:

NCT00824187

EudraCT Number:

Not Available

EU CT Number:

Not Available
YAZ Premenstrual Dysphoric Disorder (PMDD) in China

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).

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)
  • - 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
January 2009 - January 2011
Phase
Phase 3
Could I Receive a placebo
Yes
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Guangzhou, 510630, China
Completed
Guangzhou, 510405, China
Completed
Beijing, 100853, China
Completed
Jinan, 250012, China
Completed
Beijing, 100050, China
Completed
Beijing, 100191, China
Completed
Changsha, 410011, China
Completed
Wuhan, 430060, China
Completed
Xi'an, 710061, China
Completed
Kunming, 650032, China
Completed
Nanjing, 210029, China
Completed
Hangzhou, 310003, China
Completed
Nanjing, 210029, China
Completed
Xi'an, 710032, China
Completed
Tianjin, 300193, China
Completed
Dalian, 116011, China
Completed
Chengdu, 610041, China

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
    date_rangeTime Frame:
    3 cycles (1 cycle= 28 days)
    enhanced_encryption
    Safety Issue:
    no

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
    date_rangeTime Frame:
    3 cycles
    enhanced_encryption
    Safety Issue:
    no
  • 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
    date_rangeTime Frame:
    3 cylces
    enhanced_encryption
    Safety Issue:
    no
  • 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
    date_rangeTime Frame:
    3 cycles
    enhanced_encryption
    Safety Issue:
    no
  • Assessment of CGI scores
    date_rangeTime Frame:
    3 cycles
    enhanced_encryption
    Safety Issue:
    No
  • Adverse events
    date_rangeTime Frame:
    Whole study period
    enhanced_encryption
    Safety Issue:
    yes
  • Laboratory tests
    date_rangeTime Frame:
    Whole study period
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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 premenstrual dysphoric disorder (PMDD)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.