Trials / Withdrawn
WithdrawnNCT04174911
A Study to Evaluate the Safety and Efficacy of BOL-DP-o-08 in Patients With Endometriosis Syndrome.
A Randomized Phase 2a, Double-blind, Placebo-Controlled Study Examining the Safety and Efficacy of BOL-DP-o-08 in Patients With Endometriosis Syndrome.
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Breath of Life International Pharma Ltd · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 2a, Single-center, randomized, double-blind, placebo-controlled study, in 80 subjects diagnosed with Endometriosis, stage 2-4
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BOL-DP-o-08 | BOL-DP-o-08 sublingual drops |
| DRUG | Placebo | sublingual drops |
Timeline
- Start date
- 2019-01-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2019-11-22
- Last updated
- 2022-12-09
Source: ClinicalTrials.gov record NCT04174911. Inclusion in this directory is not an endorsement.