A Study to Evaluate the Safety and Efficacy of BOL-DP-o-08 in Patients With Endometriosis Syndrome.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Endometriosis
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Subjects diagnosed with Endometriosis will be eligible for enrollment. During a Screening Period of 2 weeks, inclusion and exclusion criteria will be assessed to determine if they are eligible to move into the Treatment Period. During Treatment, subjects will randomly receive either BOL-DP-o-08 or p...
Subjects diagnosed with Endometriosis will be eligible for enrollment. During a Screening Period of 2 weeks, inclusion and exclusion criteria will be assessed to determine if they are eligible to move into the Treatment Period. During Treatment, subjects will randomly receive either BOL-DP-o-08 or placebo TID for 16 weeks. At the end of the treatment, a follow-up visit for safety assessments will be conducted 4 weeks after the termination visit.
Tracking Information
- NCT #
- NCT04174911
- Collaborators
- Not Provided
- Investigators
- Not Provided
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