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

Primary Purpose

Dysmenorrhea

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
levonorgestrel/EE 0.15/0.03 mg tablets and placebo
Sponsored by
Duramed Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring cyclic pelvic pain, dysmenorrhea

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the clinical assessment of dysmenorrhea

Secondary Outcome Measures

Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms)
Incidence of menstrual bleeding and/or spotting
Analgesic use

Full Information

First Posted
September 12, 2005
Last Updated
May 9, 2014
Sponsor
Duramed Research
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1. Study Identification

Unique Protocol Identification Number
NCT00196365
Brief Title
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duramed Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
cyclic pelvic pain, dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
Other Intervention Name(s)
Seasonique
Intervention Description
1 tablet daily
Intervention Type
Drug
Intervention Name(s)
levonorgestrel/EE 0.15/0.03 mg tablets and placebo
Other Intervention Name(s)
Portia
Intervention Description
1 tablet daily
Primary Outcome Measure Information:
Title
Change from baseline in the clinical assessment of dysmenorrhea
Time Frame
Baseline to Week 4,8,12,24, and 26 or early discontinuation
Secondary Outcome Measure Information:
Title
Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms)
Time Frame
Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation
Title
Incidence of menstrual bleeding and/or spotting
Time Frame
Duration of study
Title
Analgesic use
Time Frame
Duration of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duramed Protocol Chair
Organizational Affiliation
Duramed Research, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Duramed Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Duramed Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Duramed Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Duramed Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States
Facility Name
Duramed Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Duramed Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Duramed Investigational Site
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Duramed Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28222
Country
United States
Facility Name
Duramed Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Duramed Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Duramed Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Duramed Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Duramed Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Duramed Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Duramed Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Duramed Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Duramed Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Duramed Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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