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OpenTrials
Completed

NCT Number: NCT00161681

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.

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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

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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

  1. 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

  1. 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

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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.

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