Clinical trial NCT00161681: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premenstrual Syndrome
Keywords: Levonorgestrel
ethinyl estradiol
premenstrual syndrome
menstrual cycle related symptoms
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 200
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 LNG/EE is effective in the treatment of menstrual cycle related symptoms.


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.

Primary outcomes:
measure: 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 outcomes:
measure: 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
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Longmont
country: United States
state: Colorado
city: Aventura
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
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: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Kansas City
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Moorestown
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Fayetteville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Mogadore
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Hilton Head Island
country: United States
state: South Carolina
city: Mt. Pleasant
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sandy
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Lakewood
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References: