Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS

The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.

Completed

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Key information

Conditions

Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Huntsville, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy women aged 18 to 49 years
Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1
History of menstrual cycle related symptoms as determined by the investigator.

Exclusion criteria

Contraindication to combination oral contraceptives
Depression requiring hospitalization or associated with suicidal ideation within the last 3 years
Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.

Treatment and study plan

Levonorgestrel/Ethinyl estradiol

Drug

Primary outcomes

To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo

Secondary outcomes

To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symptoms

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Sep 12, 2005
Registry last updated: Feb 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed