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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161681
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Premenstrual Syndrome Drug: Levonorgestrel/Ethinyl Estradiol Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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
Study Start Date : July 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006





Primary Outcome Measures :
  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 Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161681


Locations
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United States, Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Peoria, Arizona, United States, 85381
Phoenix, Arizona, United States, 85031
Phoenix, Arizona, United States, 85032
Tucson, Arizona, United States, 85715
United States, California
San Diego, California, United States, 92103
United States, Colorado
Denver, Colorado, United States, 80202
Longmont, Colorado, United States, 80501
United States, Florida
Aventura, Florida, United States, 33180
Boynton Beach, Florida, United States, 33437
Clearwater, Florida, United States, 33761
Deland, Florida, United States, 32720
Fort Myers, Florida, United States, 33916
Miami, Florida, United States, 33143
Miami, Florida, United States, 33186
Pembroke Pines, Florida, United States, 33024
Tampa, Florida, United States, 33607
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta, Georgia, United States, 30328
Atlanta, Georgia, United States, 30342
Savannah, Georgia, United States, 31406
United States, Idaho
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60631
United States, Kentucky
Lexington, Kentucky, United States, 40509
United States, Missouri
Kansas City, Missouri, United States, 64114
United States, Nevada
Las Vegas, Nevada, United States, 89109
Las Vegas, Nevada, United States, 89118
United States, New Jersey
Moorestown, New Jersey, United States, 08057
United States, New York
Rochester, New York, United States, 14609
United States, North Carolina
Fayetteville, North Carolina, United States, 28304
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland, Ohio, United States, 44122
Mogadore, Ohio, United States, 44260
United States, Oregon
Eugene, Oregon, United States, 97401
Medford, Oregon, United States, 97504
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15206
Wexford, Pennsylvania, United States, 15090
United States, South Carolina
Hilton Head Island, South Carolina, United States, 29926
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States, 77024
San Antonio, Texas, United States, 78229
United States, Utah
Sandy, Utah, United States, 84070
United States, Virginia
Richmond, Virginia, United States, 23226
United States, Washington
Lakewood, Washington, United States, 98499
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer

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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00161681    
Other Study ID Numbers: 0858A2-322
B3121024 ( Other Identifier: Pfizer )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: May 2007
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Levonorgestrel
ethinyl estradiol
premenstrual syndrome
menstrual cycle related symptoms
Additional relevant MeSH terms:
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Premenstrual Syndrome
Pathologic Processes
Menstruation Disturbances
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral