Clinical trial NCT00196365: A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Official title: A Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval Compared to Conventional Oral Contraceptive Therapy for Cyclic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysmenorrhea
Keywords: cyclic pelvic pain
dysmenorrhea
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe menstrual-related pain
* Regular spontaneous menstrual cycles

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Treatment with an oral contraceptive in the last 3 months
* Previous treatment failure with an extended oral contraceptive regimen

Primary outcomes:
measure: Change from baseline in the clinical assessment of dysmenorrhea
timeFrame: Baseline to Week 4,8,12,24, and 26 or early discontinuation
Secondary outcomes:
measure: Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms)
timeFrame: Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation
measure: Incidence of menstrual bleeding and/or spotting
timeFrame: Duration of study
measure: Analgesic use
timeFrame: Duration of study
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Duramed Investigational Site
state: Arizona
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: Denver
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Tampa
country: United States
facility: Duramed Investigational Site
state: Florida
city: Decatur
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Moorestown
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Charlotte
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Medford
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Duramed Investigational Site
state: Utah
city: Newport News
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Duramed Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Duramed Investigational Site
state: Washington
Study officials:
affiliation: Duramed Research, Inc.
name: Duramed Protocol Chair
role: STUDY_CHAIR
References: