YAZ Premenstrual Dysphoric Disorder (PMDD) in China

Bayer

Status and phase: Completed; Phase 3

Conditions: Premenstrual Dysphoric Disorder ( PMDD)

Treatments: Drug: EE20/DRSP(YAZ, BAY86-5300); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00824187

311962 (Other Identifier)

91771

Details and patient eligibility

About

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).

Enrollment: 187 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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187 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: EE20/DRSP(YAZ, BAY86-5300)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo