Working… Menu
Trial record 3 of 7 for:    danazol | Endometriosis

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

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

Layout table for study information
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
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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 identifier (NCT number): NCT00758953

Show Show 49 study locations
Sponsors and Collaborators
Lumara Health, Inc.
Layout table for investigator information
Study Director: Jim Joffrion Lumara Health, Inc.
Layout table for additonal information
Responsible Party: Lumara Health, Inc. Identifier: NCT00758953    
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:
Layout table for MeSH terms
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs