Endometriosis
Conditions
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.
Interventions
DRUGDanazol Once Weekly
semi-solid
DRUGDanazol Twice Weekly
semi-solid
semi-solid
DRUGPlacebo Twice Weekly
semi-solid
Sponsors
Lumara Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain associated with endometriosis | 3 months of treatment |
Countries
Canada, Russia, United States
Outcome results
None listed