Clinical trial NCT00196313: A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Official title: A Multicenter Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval to Placebo for the Treatment of Cyclic Pelvic Pain in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysmenorrhea
Keywords: cyclic pelvic pain
dysmenorrhea
oral contraceptives
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 95
Sex: FEMALE
Maximum age (years): 17
Standard ages: CHILD
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 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.


Eligibility criteria: Inclusion Criteria:

* Sexually naïve and agree to abstain from sex during the study
* Moderate to severe menstrual-related pelvic pain
* Regular spontaneous menstrual cycles

Exclusion Criteria:

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

Primary outcomes:
measure: Mean Change in Average Severity for Abdominal/Pelvic Pain
timeFrame: Baseline to end of 13-week treatment period
Secondary outcomes:
measure: Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain
timeFrame: Baseline to end of Week 13
measure: Incidence of Menstrual Bleeding and /or Spotting
timeFrame: Baseline to end of Week 13
measure: Number of Days Missed From School/Work or Other Activities
timeFrame: 13-week treatment period
measure: Analgesic Use
timeFrame: 13-week treatment period
Other outcomes:
Locations:
city: Denver
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Decatur
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Louisville
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: St. Louis
country: United States
facility: Duramed Investigational Site
state: Missouri
city: Cincinatti
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Cleveland
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: Pittsburgh
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Willow Grove
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Duramed Investigational Site
state: Rhode Island
city: Salt Lake City
country: United States
facility: Duramed Investigational Site
state: Utah
Study officials:
References: