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Clinical Trials/NCT00758953
NCT00758953
Completed
Phase 2

Pain Associated With Endometriosis

Lumara Health, Inc.0 sites66 target enrollmentFebruary 2007
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ConditionsEndometriosis
InterventionsDanazol Once WeeklyDanazol Twice WeeklyPlacebo Once WeeklyPlacebo Twice Weekly
DrugsDanazol Once WeeklyDanazol Twice WeeklyPlacebo Once WeeklyPlacebo Twice Weekly

Overview

Phase
Phase 2
Intervention
Danazol Once Weekly
Conditions
Endometriosis
Sponsor
Lumara Health, Inc.
Enrollment
66
Primary Endpoint
Pain associated with endometriosis
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2007
End Date
January 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

1

Intervention: Danazol Once Weekly

2

Intervention: Danazol Twice Weekly

3

Intervention: Placebo Once Weekly

4

Intervention: Placebo Twice Weekly

Outcomes

Primary Outcomes

Pain associated with endometriosis

Time Frame: 3 months of treatment

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