Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
NCT00161681
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Huntsville, Alabama
- Peoria, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- San Diego, California
- Denver, Colorado
- Longmont, Colorado
- Aventura, Florida
- Boynton Beach, Florida
- Clearwater, Florida
- Deland, Florida
- Fort Myers, Florida
- Miami, Florida
- Miami, Florida
- Pembroke Pines, Florida
- Tampa, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Atlanta, Georgia
- Savannah, Georgia
- Idaho Falls, Idaho
- Chicago, Illinois
- Chicago, Illinois
- Lexington, Kentucky
- Kansas City, Missouri
- Las Vegas, Nevada
- Las Vegas, Nevada
- Moorestown, New Jersey
- Rochester, New York
- Fayetteville, North Carolina
- Winston-Salem, North Carolina
- Cleveland, Ohio
- Mogadore, Ohio
- Eugene, Oregon
- Medford, Oregon
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Wexford, Pennsylvania
- Hilton Head Island, South Carolina
- Mt. Pleasant, South Carolina
- Nashville, Tennessee
- Houston, Texas
- San Antonio, Texas
- Sandy, Utah
- Richmond, Virginia
- Lakewood, Washington
- Seattle, Washington
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS | |||
Official Title ICMJE | 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 | |||
Brief Summary | The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention | |||
Condition ICMJE | Premenstrual Syndrome | |||
Intervention ICMJE | Drug: Levonorgestrel/Ethinyl Estradiol | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 200 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2006 | |||
Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 49 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00161681 | |||
Other Study ID Numbers ICMJE | 0858A2-322 B3121024 ( Other Identifier: Pfizer ) | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | May 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |