A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

Dysmenorrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196365
• Other study ID #: DR-PSE-305
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 9, 2014
• Start date: January 2005
• Est. completion date: July 2007

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Pelvic Pain

Intervention

Drug:
• levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
1 tablet daily
• levonorgestrel/EE 0.15/0.03 mg tablets and placebo
1 tablet daily

Locations

Country	Name	City	State
United States	Duramed Investigational Site	Charlotte	North Carolina
United States	Duramed Investigational Site	Columbus	Ohio
United States	Duramed Investigational Site	Columbus	Ohio
United States	Duramed Investigational Site	Decatur	Georgia
United States	Duramed Investigational Site	Denver	Colorado
United States	Duramed Investigational Site	Huntsville	Alabama
United States	Duramed Investigational Site	Medford	Oregon
United States	Duramed Investigational Site	Memphis	Tennessee
United States	Duramed Investigational Site	Moorestown	New Jersey
United States	Duramed Investigational Site	Newport News	Virginia
United States	Duramed Investigational Site	Norfolk	Virginia
United States	Duramed Investigational Site	Philadelphia	Pennsylvania
United States	Duramed Investigational Site	Phoenix	Arizona
United States	Duramed Investigational Site	Salt Lake City	Utah
United States	Duramed Investigational Site	San Diego	California
United States	Duramed Investigational Site	Spokane	Washington
United States	Duramed Investigational Site	Tacoma	Washington
United States	Duramed Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the clinical assessment of dysmenorrhea		Baseline to Week 4,8,12,24, and 26 or early discontinuation	No
Secondary	Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms)		Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation	No
Secondary	Incidence of menstrual bleeding and/or spotting		Duration of study	No
Secondary	Analgesic use		Duration of study	No