YAZ Premenstrual Dysphoric Disorder (PMDD) in China
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premenstrual Dysphoric Disorder ( PMDD)
Intervention: EE20/DRSP(YAZ, BAY86-5300) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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
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 cyclesDescriptive 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
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
Beijing 100050, China
Beijing 100191, China
Beijing 100853, China
Tianjin 300193, China
Guangzhou, Guangdong 510405, China
Guangzhou, Guangdong 510630, China
Wuhan, Hubei 430060, China
Changsha, Hunan 410011, China
Nanjing, Jiangsu 210029, China
Dalian, Liaoning 116011, China
Jinan, Shandong 250012, China
Xi'an, Shanxi 710032, China
Xi'an, Shanxi 710061, China
Chengdu, Sichuan 610041, China
Kunming, Yunnan 650032, China
Hangzhou, Zhejiang 310003, China
Additional Information
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Starting date: January 2009
Last updated: April 1, 2014
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