Pain Associated With Endometriosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lumara Health, Inc.
ClinicalTrials.gov Identifier:
NCT00758953
First received: September 23, 2008
Last updated: March 2, 2012
Last verified: March 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758953

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

No publications provided

Responsible Party: Lumara Health, Inc.
ClinicalTrials.gov Identifier: NCT00758953     History of Changes
Other Study ID Numbers: DZ2-201-601-725036
Study First Received: September 23, 2008
Last Updated: March 2, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation

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

ClinicalTrials.gov processed this record on September 14, 2014