Clinical trial NCT00824187: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premenstrual Dysphoric Disorder ( PMDD)
Keywords: Premenstrual Dysphoric Disorder ( PMDD)
Oral contraceptive
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 187
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 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
timeFrame: 3 cycles (1 cycle= 28 days)
Secondary outcomes:
measure: 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
timeFrame: 3 cycles
measure: 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
timeFrame: 3 cylces
measure: 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
timeFrame: 3 cycles
measure: Assessment of CGI scores
timeFrame: 3 cycles
measure: Adverse events
timeFrame: Whole study period
measure: Laboratory tests
timeFrame: Whole study period
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Wuhan
country: China
state: Hubei
city: Changsha
country: China
state: Hunan
city: Nanjing
country: China
state: Jiangsu
city: Dalian
country: China
state: Liaoning
city: Jinan
country: China
state: Shandong
city: Xi'an
country: China
state: Shanxi
city: Xi'an
country: China
state: Shanxi
city: Chengdu
country: China
state: Sichuan
city: Kunming
country: China
state: Yunnan
city: Hangzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Tianjin
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: