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...
Brief Summary
Official 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”
The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Intervention(s) in this Clinical Trial
- Drug: Levonorgestrel/Ethinyl Estradiol
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 49 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor, MD Study Director Wyeth is now a wholly owned subsidiary of Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00161681
Study ID Number: 0858A2-322
ClinicalTrials.gov Identifier: NCT00161681
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00161681
