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

Primary Purpose

Premenstrual Syndrome, Menstruation Disturbances

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Levonorgestrel/Ethinyl Estradiol

About this trial

This is an interventional prevention trial for Premenstrual Syndrome focused on measuring Premenstrual Syndrome (PMS), Hormone Therapy

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score

Secondary Outcome Measures

Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle

Full Information

NCT ID

NCT00195559

First Posted

September 13, 2005

Last Updated

December 18, 2007

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00195559

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premenstrual Syndrome, Menstruation Disturbances

Keywords

Premenstrual Syndrome (PMS), Hormone Therapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

526 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Levonorgestrel/Ethinyl Estradiol

Primary Outcome Measure Information:

Title

Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score

Secondary Outcome Measure Information:

Title

Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: