Back to resultsStudy Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
Primary Purpose
Menstruation Disturbances, Premenstrual Syndrome
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
levonorgestrel/ethinyl estradiol
Sponsored by
About this trial
This is an interventional prevention trial for Menstruation Disturbances focused on measuring Premenstrual Syndrome (PMS), Hormone Therapy
Eligibility Criteria
Inclusion Criteria: Generally healthy, women aged 18 to 49 years. History of severe PMS symptoms over the last year, as determined by the investigator. Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit. Exclusion Criteria: Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years. Contraindication to combination oral contraceptives. Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study. Other exclusions apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary Outcome Measures
Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
Full Information
NCT ID
NCT00128934
First Posted
August 8, 2005
Last Updated
December 18, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00128934
Brief Title
Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstruation Disturbances, Premenstrual Syndrome
Keywords
Premenstrual Syndrome (PMS), Hormone Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
744 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
levonorgestrel/ethinyl estradiol
Primary Outcome Measure Information:
Title
Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary Outcome Measure Information:
Title
Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Generally healthy, women aged 18 to 49 years.
History of severe PMS symptoms over the last year, as determined by the investigator.
Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.
Exclusion Criteria:
Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years.
Contraindication to combination oral contraceptives.
Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
Other exclusions apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
City
Adventure
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60631
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
City
New York City
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29654
Country
United States
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
City
Hull
State/Province
Quebec
ZIP/Postal Code
J9A 1K7
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1P6
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2W8
Country
Canada
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
City
Shawinigan
State/Province
Quebec
ZIP/Postal Code
G9N 2H6
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4J6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22067793
Citation
Halbreich U, Freeman EW, Rapkin AJ, Cohen LS, Grubb GS, Bergeron R, Smith L, Mirkin S, Constantine GD. Continuous oral levonorgestrel/ethinyl estradiol for treating premenstrual dysphoric disorder. Contraception. 2012 Jan;85(1):19-27. doi: 10.1016/j.contraception.2011.05.008. Epub 2011 Jul 13.
Results Reference
derived
Learn more about this trial
Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
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