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COMPLETEDPhase 3NCT00128934

Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder

The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).

Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer•69 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Age

18 - 49 years

Sex

FEMALE

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 exclusions apply.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 27, 2007Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment744

Start dateAug 2005

Last updatedDec 27, 2007

Condition

Menstruation Disturbances Premenstrual Syndrome

Locations shown

Scottsdale, Arizona

Tucson, Arizona

Jonesboro, Arkansas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2007Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions