NCT00824187

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

January 15, 2009

Last Update Submit

April 1, 2014

Conditions

Premenstrual Dysphoric Disorder ( PMDD)

Keywords

Premenstrual Dysphoric Disorder ( PMDD)Oral contraceptive

Outcome Measures

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

    3 cycles (1 cycle= 28 days)

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Arm 1

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

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

EE20/DRSP(YAZ, BAY86-5300)DRUG

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

Arm 1
PlaceboDRUG

Inert tablet

Arm 2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Guangzhou, Guangdong, 510405, China

Location

Unknown Facility

Guangzhou, Guangdong, 510630, China

Location

Unknown Facility

Wuhan, Hubei, 430060, China

Location

Unknown Facility

Changsha, Hunan, 410011, China

Location

Unknown Facility

Nanjing, Jiangsu, 210029, China

Location

Unknown Facility

Dalian, Liaoning, 116011, China

Location

Unknown Facility

Jinan, Shandong, 250012, China

Location

Unknown Facility

Xi’an, Shanxi, 710032, China

Location

Unknown Facility

Xi’an, Shanxi, 710061, China

Location

Unknown Facility

Chengdu, Sichuan, 610041, China

Location

Unknown Facility

Kunming, Yunnan, 650032, China

Location

Unknown Facility

Hangzhou, Zhejiang, 310003, China

Location

Unknown Facility

Beijing, 100050, China

Location

Unknown Facility

Beijing, 100191, China

Location

Unknown Facility

Beijing, 100853, China

Location

Unknown Facility

Tianjin, 300193, China

Location

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Premenstrual SyndromeMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 2, 2014

Record last verified: 2014-04

Locations

CN(16)