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

Phase 2

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets; Drug: Placebo tablet

• Registration Number: NCT00196313
• Lead Sponsor: Duramed Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2011-10-12
• Results First Submitted QC: 2012-04-25
• Results First Posted: 2012-05-25
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet	levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets	-
2	Placebo tablet	-

Primary Outcome Measures

Name	Time	Method
Mean Change in Average Severity for Abdominal/Pelvic Pain	Baseline to end of 13-week treatment period	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")

Secondary Outcome Measures

Name	Time	Method
Incidence of Menstrual Bleeding and /or Spotting	Baseline to end of Week 13
Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain	Baseline to end of Week 13	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")
Number of Days Missed From School/Work or Other Activities	13-week treatment period
Analgesic Use	13-week treatment period	number of days analgesic (pain) medication was used over the 13 week treatment period

Trial Locations

Locations (1)

Duramed Investigational Site; 🇺🇸 Salt Lake City, Utah, United States