Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00161681
Collaborator
(none)
200
48
13
4.2
0.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
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
:
Jul 1, 2005
Actual Primary Completion Date
:
Aug 1, 2006
Actual Study Completion Date
:
Aug 1, 2006
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huntsville | Alabama | United States | 35801 | |
| 2 | Peoria | Arizona | United States | 85381 | |
| 3 | Phoenix | Arizona | United States | 85031 | |
| 4 | Phoenix | Arizona | United States | 85032 | |
| 5 | Tucson | Arizona | United States | 85715 | |
| 6 | San Diego | California | United States | 92103 | |
| 7 | Denver | Colorado | United States | 80202 | |
| 8 | Longmont | Colorado | United States | 80501 | |
| 9 | Aventura | Florida | United States | 33180 | |
| 10 | Boynton Beach | Florida | United States | 33437 | |
| 11 | Clearwater | Florida | United States | 33761 | |
| 12 | Deland | Florida | United States | 32720 | |
| 13 | Fort Myers | Florida | United States | 33916 | |
| 14 | Miami | Florida | United States | 33143 | |
| 15 | Miami | Florida | United States | 33186 | |
| 16 | Pembroke Pines | Florida | United States | 33024 | |
| 17 | Tampa | Florida | United States | 33607 | |
| 18 | West Palm Beach | Florida | United States | 33407 | |
| 19 | Atlanta | Georgia | United States | 30328 | |
| 20 | Atlanta | Georgia | United States | 30342 | |
| 21 | Savannah | Georgia | United States | 31406 | |
| 22 | Idaho Falls | Idaho | United States | 83404 | |
| 23 | Chicago | Illinois | United States | 60612 | |
| 24 | Chicago | Illinois | United States | 60631 | |
| 25 | Lexington | Kentucky | United States | 40509 | |
| 26 | Kansas City | Missouri | United States | 64114 | |
| 27 | Las Vegas | Nevada | United States | 89109 | |
| 28 | Las Vegas | Nevada | United States | 89118 | |
| 29 | Moorestown | New Jersey | United States | 08057 | |
| 30 | Rochester | New York | United States | 14609 | |
| 31 | Fayetteville | North Carolina | United States | 28304 | |
| 32 | Winston-Salem | North Carolina | United States | 27103 | |
| 33 | Cleveland | Ohio | United States | 44122 | |
| 34 | Mogadore | Ohio | United States | 44260 | |
| 35 | Eugene | Oregon | United States | 97401 | |
| 36 | Medford | Oregon | United States | 97504 | |
| 37 | Philadelphia | Pennsylvania | United States | 19104 | |
| 38 | Pittsburgh | Pennsylvania | United States | 15206 | |
| 39 | Wexford | Pennsylvania | United States | 15090 | |
| 40 | Hilton Head Island | South Carolina | United States | 29926 | |
| 41 | Mt. Pleasant | South Carolina | United States | 29464 | |
| 42 | Nashville | Tennessee | United States | 37203 | |
| 43 | Houston | Texas | United States | 77024 | |
| 44 | San Antonio | Texas | United States | 78229 | |
| 45 | Sandy | Utah | United States | 84070 | |
| 46 | Richmond | Virginia | United States | 23226 | |
| 47 | Lakewood | Washington | United States | 98499 | |
| 48 | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, MD, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00161681
Other Study ID Numbers:
- 0858A2-322
- B3121024
First Posted:
Sep 12, 2005
Last Update Posted:
Feb 8, 2013
Last Verified:
May 1, 2007
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer
Additional relevant MeSH terms: