Pain Associated With Endometriosis

March 2, 2012 updated by: Lumara Health, Inc.
This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 3G8
      • North Vancouver, British Columbia, Canada, V7M 2H5
      • Penicton, British Columbia, Canada, V2A 5G8
    • Ontario
      • Halifax, Ontario, Canada, B3K 5R5
      • Ottawa, Ontario, Canada, K1V 0Y3
      • Toronto, Ontario, Canada, M5H 3P5
      • Whitby, Ontario, Canada, L1N 4V6
      • Windsor, Ontario, Canada, N8N 4X9
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1N8
  • Russian Federation
      • Moscow, Russian Federation
      • St. Petersburg, Russian Federation
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
      • Phoenix, Arizona, United States, 85032
      • Phoenix, Arizona, United States, 85015
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Carmichael, California, United States, 95608
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92121
      • San Diego, California, United States, 92130
    • Colorado
      • Denver, Colorado, United States, 80206
    • Connecticut
      • Britain, Connecticut, United States, 06050
      • West Hartford, Connecticut, United States, 06117
    • Florida
      • Aventura, Florida, United States, 33180
      • Boynton Beach, Florida, United States, 33437
      • Clearwater, Florida, United States, 33759
      • Hudson, Florida, United States, 34667
      • Tampa, Florida, United States, 33607
    • Georgia
      • Alpharetta, Georgia, United States, 30005
      • Atlanta, Georgia, United States, 30342
      • Decatur, Georgia, United States, 30034
    • Idaho
      • Boise, Idaho, United States, 83712
      • Boise, Idaho, United States, 83702
    • Illinois
      • Champaign, Illinois, United States, 61820
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
    • Missouri
      • Chesterfield, Missouri, United States, 63017
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58104
    • Ohio
      • Cleveland, Ohio, United States, 44122
      • Columbus, Ohio, United States, 43231
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
      • West Chester, Pennsylvania, United States, 19380
    • Tennessee
      • Jackson, Tennessee, United States, 38305
      • Memphis, Tennessee, United States, 38119
      • Memphis, Tennessee, United States, 38120
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Irving, Texas, United States, 75061
    • Utah
      • Salt Lake City, Utah, United States, 84107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Menstruating female 18-50 years of age,
  • Regular cycle length of 21 to 35 days with menstrual bleeding that typically lasts no more than 7 days,
  • Has pain associated with endometriosis,
  • Has a documented history consistent with endometriosis,

Exclusion Criteria:

  • Is pregnant or lactating,
  • Has a history of or has active thrombosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Danazol Once Weekly
semi-solid
Experimental: 2
Drug: Danazol Twice Weekly
semi-solid
Placebo Comparator: 4
Drug: Placebo Twice Weekly
semi-solid
Placebo Comparator: 3
Drug: Placebo Once Weekly
semi-solid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain associated with endometriosis
Time Frame: 3 months of treatment
3 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumara Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2012

Last Update Submitted That Met QC Criteria

March 2, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DZ2-201-601-725036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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