YAZ Premenstrual Dysphoric Disorder (PMDD) in China

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)

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).

Study Overview

• Status: Completed
• Conditions: Premenstrual Dysphoric Disorder ( PMDD)
• Intervention / Treatment: Drug: EE20/DRSP(YAZ, BAY86-5300); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100050
  • Beijing, China, 100191
  • Beijing, China, 100853
  • Tianjin, China, 300193
  • Guangdong
    • Guangzhou, Guangdong, China, 510405
    • Guangzhou, Guangdong, China, 510630
  • Hubei
    • Wuhan, Hubei, China, 430060
  • Hunan
    • Changsha, Hunan, China, 410011
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
  • Liaoning
    • Dalian, Liaoning, China, 116011
  • Shandong
    • Jinan, Shandong, China, 250012
  • Shanxi
    • Xi'an, Shanxi, China, 710061
    • Xi'an, Shanxi, China, 710032
  • Sichuan
    • Chengdu, Sichuan, China, 610041
  • Yunnan
    • Kunming, Yunnan, China, 650032
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: EE20/DRSP(YAZ, BAY86-5300); 20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
Placebo Comparator: Arm 2	Drug: Placebo; Inert tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	3 cycles (1 cycle= 28 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
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	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	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	3 cycles
Assessment of CGI scores	3 cycles
Adverse events	Whole study period
Laboratory tests	Whole study period

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: January 15, 2009
• First Submitted That Met QC Criteria: January 15, 2009
• First Posted (Estimate): January 16, 2009

Study Record Updates

• Last Update Posted (Estimate): April 2, 2014
• Last Update Submitted That Met QC Criteria: April 1, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Oral contraceptive; Premenstrual Dysphoric Disorder ( PMDD)
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Menstruation Disturbances; Premenstrual Syndrome; Disease; Premenstrual Dysphoric Disorder
• Other Study ID Numbers: 91771; 311962 (Other Identifier: Company Internal)