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Pain Associated With Endometriosis

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.
ClinicalTrials.gov Identifier: NCT00758953
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : March 6, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Danazol Once Weekly Drug: Danazol Twice Weekly Drug: Placebo Once Weekly Drug: Placebo Twice Weekly Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2007
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Danazol Once Weekly
Experimental: 2 Drug: Danazol Twice Weekly
Placebo Comparator: 3 Drug: Placebo Once Weekly
Placebo Comparator: 4 Drug: Placebo Twice Weekly

Outcome Measures

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

Eligibility Criteria

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

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.
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 Posted: September 25, 2008    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012

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