YAZ Premenstrual Dysphoric Disorder (PMDD) in China

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Premenstrual Dysphoric Disorder ( PMDD)

Intervention / Treatment
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* Drug: EE20/DRSP(YAZ, BAY86-5300)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: EE20/DRSP(YAZ, BAY86-5300)<br>* 20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Inert tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premenstrual Dysphoric Disorder ( PMDD), Oral contraceptive