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Completed

NCT Number: NCT00824187

YAZ Premenstrual Dysphoric Disorder (PMDD) in China

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).

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Key information

Conditions

Premenstrual Dysphoric Disorder ( PMDD) Depressive Disorder Menstruation Disturbances Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Dysphoric Disorder Premenstrual Syndrome

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EE20/DRSP(YAZ, BAY86-5300)

Drug

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

Placebo

Drug

Inert tablet

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. Assessment of CGI scores

    Time frame: 3 cycles

  5. Adverse events

    Time frame: Whole study period

  6. Laboratory tests

    Time frame: Whole study period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 16, 2009
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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