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

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

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.

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea
• Intervention / Treatment: Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets; Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Duramed Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Duramed Investigational Site
  • California
    • San Diego, California, United States, 92108
      • Duramed Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80202
      • Duramed Investigational Site
  • Florida
    • Tampa, Florida, United States, 33607
      • Duramed Investigational Site
  • Georgia
    • Decatur, Georgia, United States, 30034
      • Duramed Investigational Site
  • New Jersey
    • Moorestown, New Jersey, United States, 08057
      • Duramed Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28222
      • Duramed Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Duramed Investigational Site
    • Columbus, Ohio, United States, 43205
      • Duramed Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Duramed Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Duramed Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Duramed Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Duramed Investigational Site
  • Virginia
    • Newport News, Virginia, United States, 23602
      • Duramed Investigational Site
    • Norfolk, Virginia, United States, 23507
      • Duramed Investigational Site
  • Washington
    • Spokane, Washington, United States, 99207
      • Duramed Investigational Site
    • Tacoma, Washington, United States, 98405
      • Duramed Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets; 1 tablet daily; Other Names: Seasonique
Active Comparator: 2	Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo; 1 tablet daily; Other Names: Portia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the clinical assessment of dysmenorrhea	Baseline to Week 4,8,12,24, and 26 or early discontinuation

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Incidence of menstrual bleeding and/or spotting	Duration of study
Analgesic use	Duration of study

Collaborators and Investigators

• Sponsor: Duramed Research

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): May 12, 2014
• Last Update Submitted That Met QC Criteria: May 9, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: dysmenorrhea; cyclic pelvic pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Dysmenorrhea; Pelvic Pain; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: DR-PSE-305