Pain Associated With Endometriosis

Endometriosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758953
• Other study ID #: DZ2-201-601-725036
• Status: Completed
• Phase: Phase 2
• First received: September 23, 2008
• Last updated: March 2, 2012
• Start date: February 2007
• Est. completion date: January 2009

Study information

• Verified date: March 2012
• Source: Lumara Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Danazol Once Weekly
semi-solid
• Danazol Twice Weekly
semi-solid
• Placebo Once Weekly
semi-solid
• Placebo Twice Weekly
semi-solid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lumara Health, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain associated with endometriosis		3 months of treatment	No