Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

Premenstrual Syndrome Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195559
• Other study ID #: 0858A4-318
• 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
• 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

• Menstruation Disturbances
• Premenstrual Syndrome

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