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Pain Associated With Endometriosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758953
First Posted: September 25, 2008
Last Update Posted: March 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lumara Health, Inc.
  Purpose
This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.

Condition Intervention Phase
Endometriosis Drug: Danazol Once Weekly Drug: Danazol Twice Weekly Drug: Placebo Once Weekly Drug: Placebo Twice Weekly Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Lumara Health, Inc.:

Primary Outcome Measures:
  • Pain associated with endometriosis [ Time Frame: 3 months of treatment ]

Enrollment: 66
Study Start Date: February 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Danazol Once Weekly
semi-solid
Experimental: 2 Drug: Danazol Twice Weekly
semi-solid
Placebo Comparator: 3 Drug: Placebo Once Weekly
semi-solid
Placebo Comparator: 4 Drug: Placebo Twice Weekly
semi-solid

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758953


  Show 49 Study Locations
Sponsors and Collaborators
Lumara Health, Inc.
Investigators
Study Director: Jim Joffrion Lumara Health, Inc.
  More Information

Responsible Party: Lumara Health, Inc.
ClinicalTrials.gov Identifier: NCT00758953     History of Changes
Other Study ID Numbers: DZ2-201-601-725036
First Submitted: September 23, 2008
First Posted: September 25, 2008
Last Update Posted: March 6, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Danazol
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs