YAZ Premenstrual Dysphoric Disorder (PMDD) in China

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00824187
First received: January 15, 2009
Last updated: April 1, 2014
Last verified: April 2014
  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).


Condition Intervention Phase
Premenstrual Dysphoric Disorder ( PMDD)
Drug: EE20/DRSP(YAZ, BAY86-5300)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Premenstrual Dysphoric Disorder (PMDD)

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as 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 [ Time Frame: 3 cylces ] [ Designated as 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 [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
  • Assessment of CGI scores [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]

Enrollment: 187
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824187

Locations
China, Guangdong
Guangzhou, Guangdong, China, 510405
Guangzhou, Guangdong, China, 510630
China, Hubei
Wuhan, Hubei, China, 430060
China, Hunan
Changsha, Hunan, China, 410011
China, Jiangsu
Nanjing, Jiangsu, China, 210029
China, Liaoning
Dalian, Liaoning, China, 116011
China, Shandong
Jinan, Shandong, China, 250012
China, Shanxi
Xi'an, Shanxi, China, 710061
Xi'an, Shanxi, China, 710032
China, Sichuan
Chengdu, Sichuan, China, 610041
China, Yunnan
Kunming, Yunnan, China, 650032
China, Zhejiang
Hangzhou, Zhejiang, China, 310003
China
Beijing, China, 100191
Beijing, China, 100050
Beijing, China, 100853
Tianjin, China, 300193
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00824187     History of Changes
Other Study ID Numbers: 91771, 311962
Study First Received: January 15, 2009
Last Updated: April 1, 2014
Health Authority: China: State Food and Drug Administration (SFDA)

Keywords provided by Bayer:
Premenstrual Dysphoric Disorder ( PMDD)
Oral contraceptive

Additional relevant MeSH terms:
Disease
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Contraceptive Agents
Contraceptives, Oral
Contraceptive Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014