Premenstrual Dysphoric Disorder ( PMDD)
Conditions
Keywords
Premenstrual Dysphoric Disorder ( PMDD), Oral contraceptive
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).
Interventions
20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
DRUGPlacebo
Inert tablet
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Adverse events | Whole study period |
| Laboratory tests | Whole study period |
| Assessment of CGI scores | 3 cycles |
Countries
China
Outcome results
None listed