YAZ Premenstrual Dysphoric Disorder (PMDD) in China

Phase 3

Completed

• Conditions: Premenstrual Dysphoric Disorder ( PMDD)
• Interventions: Drug: EE20/DRSP(YAZ, BAY86-5300); Drug: Placebo

• Registration Number: NCT00824187
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-16
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 187

Inclusion Criteria

• Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	EE20/DRSP(YAZ, BAY86-5300)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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	3 cycles (1 cycle= 28 days)

Secondary Outcome Measures

Name	Time	Method
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	3 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	3 cylces
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	3 cycles
Assessment of CGI scores	3 cycles
Adverse events	Whole study period
Laboratory tests	Whole study period