YAZ Premenstrual Dysphric Disorder (PMDD) in China
Information source: Bayer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premenstrual Dysphoric Disorder ( PMDD)
Intervention: YAZ (SH T00186, BAY86-5300) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy variable is the difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days of the 3rd treatment cycle to average scores from the last 5 days of the 2 run in cycles
Secondary outcome: Descriptive statistics for total DRSP scale scores for each of the 2 run cycles, each of the 3 treatment cycles, and the average of the 3 treatment cyclesDifference in DRSP scale scores for the 3 functional impairment items, comparing the average of daily scores from the 3rd treatment cycle to the average of daily scores from the 2 run in cycles 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 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
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Beijing 100083, China; Recruiting
Tianjin 300193, China; Recruiting
Tianjin 300150, China; Not yet recruiting
Guangzhou, Guangdong 510630, China; Recruiting
Guangzhou,, Guangdong 510405, China; Recruiting
Wuhan, Hubei 430060, China; Recruiting
Changsha, Hunan 410013, China; Recruiting
Nanjing, Jiangsu 210029, China; Recruiting
Xi'an, Shanxi 710061, China; Recruiting
Xi'an, Shanxi 710032, China; Recruiting
Kunming, Yunnan 650032, China; Recruiting
Hangzhou, Zhejiang 310003, China; Recruiting
Additional Information
Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product Click here to find results for studies related to marketed products
Starting date: January 2009
Ending date: January 2011
Last updated: October 6, 2009
|
