Back to resultsYAZ Premenstrual Dysphoric Disorder (PMDD) in China
Primary Purpose
Premenstrual Dysphoric Disorder ( PMDD)
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
EE20/DRSP(YAZ, BAY86-5300)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Dysphoric Disorder ( PMDD) focused on measuring Premenstrual Dysphoric Disorder ( PMDD), Oral contraceptive
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
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
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
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
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
Assessment of CGI scores
Adverse events
Laboratory tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00824187
Brief Title
YAZ Premenstrual Dysphoric Disorder (PMDD) in China
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Dysphoric Disorder ( PMDD)
Keywords
Premenstrual Dysphoric Disorder ( PMDD), Oral contraceptive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
EE20/DRSP(YAZ, BAY86-5300)
Intervention Description
20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inert tablet
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Assessment of CGI scores
Time Frame
3 cycles
Title
Adverse events
Time Frame
Whole study period
Title
Laboratory tests
Time Frame
Whole study period
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
City
Beijing
ZIP/Postal Code
100050
Country
China
City
Beijing
ZIP/Postal Code
100191
Country
China
City
Beijing
ZIP/Postal Code
100853
Country
China
City
Tianjin
ZIP/Postal Code
300193
Country
China
12. IPD Sharing Statement
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YAZ Premenstrual Dysphoric Disorder (PMDD) in China
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