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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00195559
Other study ID # 0858A4-318
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated December 18, 2007
Start date September 2005
Est. completion date December 2007

Study information

Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 526
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Levonorgestrel/Ethinyl Estradiol


Locations

Country Name City State
Romania S Bucuresti

Sponsors (1)

Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Denmark,  Finland,  Germany,  Mexico,  Netherlands,  Poland,  Romania,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
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