Pain Associated With Endometriosis

Lumara Health

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: Danazol Once Weekly; Drug: Placebo Once Weekly; Drug: Placebo Twice Weekly; Drug: Danazol Twice Weekly

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758953

DZ2-201-601-725036

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Danazol Once Weekly

2

Experimental group

Treatment:

Drug: Danazol Twice Weekly

3

Placebo Comparator group

Treatment:

Drug: Placebo Once Weekly

4

Placebo Comparator group

Treatment:

Drug: Placebo Twice Weekly