Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
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
2 other identifiers
interventional
200
1 country
48
Brief Summary
The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2005
Shorter than P25 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFebruary 8, 2013
May 1, 2007
1.1 years
September 7, 2005
February 7, 2013
Conditions
Keywords
Outcome Measures
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Peoria, Arizona, 85381, United States
Unknown Facility
Phoenix, Arizona, 85031, United States
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Tucson, Arizona, 85715, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Denver, Colorado, 80202, United States
Unknown Facility
Longmont, Colorado, 80501, United States
Unknown Facility
Aventura, Florida, 33180, United States
Unknown Facility
Boynton Beach, Florida, 33437, United States
Unknown Facility
Clearwater, Florida, 33761, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Fort Myers, Florida, 33916, United States
Unknown Facility
Miami, Florida, 33143, United States
Unknown Facility
Miami, Florida, 33186, United States
Unknown Facility
Pembroke Pines, Florida, 33024, United States
Unknown Facility
Tampa, Florida, 33607, United States
Unknown Facility
West Palm Beach, Florida, 33407, United States
Unknown Facility
Atlanta, Georgia, 30328, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Savannah, Georgia, 31406, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Chicago, Illinois, 60631, United States
Unknown Facility
Lexington, Kentucky, 40509, United States
Unknown Facility
Kansas City, Missouri, 64114, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Las Vegas, Nevada, 89118, United States
Unknown Facility
Moorestown, New Jersey, 08057, United States
Unknown Facility
Rochester, New York, 14609, United States
Unknown Facility
Fayetteville, North Carolina, 28304, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cleveland, Ohio, 44122, United States
Unknown Facility
Mogadore, Ohio, 44260, United States
Unknown Facility
Eugene, Oregon, 97401, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15206, United States
Unknown Facility
Wexford, Pennsylvania, 15090, United States
Unknown Facility
Hilton Head Island, South Carolina, 29926, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Houston, Texas, 77024, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Sandy City, Utah, 84070, United States
Unknown Facility
Richmond, Virginia, 23226, United States
Unknown Facility
Lakewood, Washington, 98499, United States
Unknown Facility
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
July 1, 2005
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
February 8, 2013
Record last verified: 2007-05