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

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Levonorgestrel/Ethinyl Estradiol
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premenstrual Syndrome focused on measuring Levonorgestrel, ethinyl estradiol, premenstrual syndrome, menstrual cycle related symptoms

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome 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 Outcome 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

Full Information

First Posted
September 7, 2005
Last Updated
February 7, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00161681
Brief Title
Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
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 Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 LNG/EE is effective in the treatment of menstrual cycle related symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Levonorgestrel, ethinyl estradiol, premenstrual syndrome, menstrual cycle related symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Levonorgestrel/Ethinyl Estradiol
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

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: 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.
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
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85031
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
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
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
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
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60631
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89118
Country
United States
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
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
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
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
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
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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