Clinical trial NCT00128934: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menstruation Disturbances
Premenstrual Syndrome
Keywords: Premenstrual Syndrome (PMS)
Hormone Therapy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-10
Enrollment: 744
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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.

Primary outcomes:
measure: Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary outcomes:
measure: Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Carmichael
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Longmont
country: United States
state: Colorado
city: Middletown
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Adventure
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Glen Burnie
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Pittsfield
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Brooklyn
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: New York City
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Fayetteville
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Mogadore
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: Greer
country: United States
state: South Carolina
city: Hilton Head Island
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Conroe
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Sandy
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Lakewood
country: United States
state: Washington
city: Renton
country: United States
state: Washington
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Hull
country: Canada
state: Quebec
city: MontrÃ©al
country: Canada
state: Quebec
city: MontrÃ©al
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Shawinigan
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
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.