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YAZ Premenstrual Dysphoric Disorder (PMDD) in China

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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

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

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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