YAZ Premenstrual Dysphoric Disorder (PMDD) in China

Bayer187 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

187

Conditions

Premenstrual Dysphoric Disorder ( PMDD)

Interventions

EE20/DRSP(YAZ, BAY86-5300)DRUG

20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd

PlaceboDRUG

Inert tablet

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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 (16)

Unnamed facility

Guangzhou, Guangdong, China

Unnamed facility

Guangzhou, Guangdong, China

Unnamed facility

Wuhan, Hubei, China

Outcomes

Primary Outcomes

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

Time frame: 3 cycles (1 cycle= 28 days)

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 3 cycles

Assessment of CGI scores

Time frame: 3 cycles

Adverse events

Time frame: Whole study period

Laboratory tests

Time frame: Whole study period

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.