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

Dysmenorrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196313
• Other study ID #: DR-PSE-306
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: September 21, 2015
• Start date: May 2005
• Est. completion date: October 2008

Study information

• Verified date: September 2015
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: 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 by mouth
• Placebo tablet
1 tablet daily by mouth

Locations

Country	Name	City	State
United States	Duramed Investigational Site	Cincinatti	Ohio
United States	Duramed Investigational Site	Cleveland	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	Louisville	Kentucky
United States	Duramed Investigational Site	Medford	Oregon
United States	Duramed Investigational Site	Philadelphia	Pennsylvania
United States	Duramed Investigational Site	Pittsburgh	Pennsylvania
United States	Duramed Investigational Site	Providence	Rhode Island
United States	Duramed Investigational Site	Salt Lake City	Utah
United States	Duramed Investigational Site	St. Louis	Missouri
United States	Duramed Investigational Site	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Average Severity for Abdominal/Pelvic Pain	Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")	Baseline to end of 13-week treatment period	No
Secondary	Maximum Severity of Abdominal/Pelvic Pain	Maximum pain severity score was calculated by identifying each subject's maximum recorded pain severity from baseline to end of Week 13.; The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")	Baseline to end of Week 13	No
Secondary	Incidence of Menstrual Bleeding and /or Spotting		Baseline to end of Week 13	No
Secondary	Number of Days Missed From School/Work or Other Activities		13-week treatment period	No
Secondary	Analgesic Use	number of days analgesic (pain) medication was used over the 13 week treatment period	13-week treatment period	No