Pain Associated With Endometriosis

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: Danazol Once Weekly; Drug: Danazol Twice Weekly; Drug: Placebo Once Weekly; Drug: Placebo Twice Weekly

• Registration Number: NCT00758953
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Disposition First Submitted: 2010-01-11
• Disposition First Submitted QC: 2010-01-11
• Disposition First Posted: 2010-01-13
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-02
• Last Update Posted: 2012-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Danazol Once Weekly	-
2	Danazol Twice Weekly	-
3	Placebo Once Weekly	-
4	Placebo Twice Weekly	-

Primary Outcome Measures

Name	Time	Method
Pain associated with endometriosis	3 months of treatment