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A Study to Evaluate the Safety and Efficacy of BOL-DP-o-08 in Patients With Endometriosis Syndrome.

Endometriosis Clinical Trial

Official title:
A Randomized Phase 2a, Double-blind, Placebo-Controlled Study Examining the Safety and Efficacy of BOL-DP-o-08 in Patients With Endometriosis Syndrome.

Clinical Trial Summary

A Phase 2a, Single-center, randomized, double-blind, placebo-controlled study, in 80 subjects diagnosed with Endometriosis, stage 2-4

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04174911
Study type Interventional
Source Breath of Life International Pharma Ltd
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date January 2019
Completion date December 2020
View Details
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