Menstruation Disturbances, Premenstrual Syndrome
Conditions
Keywords
Premenstrual Syndrome (PMS), Hormone Therapy
Brief summary
The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Generally healthy, women aged 18 to 49 years. * History of severe PMS symptoms over the last year, as determined by the investigator. * Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.
Exclusion criteria
* Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years. * Contraindication to combination oral contraceptives. * Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study. Other exclusion applies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each estimated treatment cycle | — |
Countries
Argentina, Brazil, Chile, Denmark, Finland, Germany, Mexico, Netherlands, Poland, Romania, Sweden, United Kingdom
Outcome results
None listed