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.

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

Study Overview

• Status: Withdrawn
• Conditions: Endometriosis
• Intervention / Treatment: Drug: BOL-DP-o-08; Drug: Placebo

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Adult subjects, aged 18 years old
• Regular menstrual cycles
• Endometriosis diagnosed by ultrasonography and gynecological examination, or laparotomy, laparoscopy or imaging analysis (combination of magnetic resonance imaging and ultrasonography) of endometriotic ovarian chocolate cysts
• The presence of subjective symptoms during menstruation (at least one from among lower abdominal pain, lumbago, defecation pain, nausea and headache
• The presence of subjective symptoms during non-menstruation (at least one from among lower abdominal pain, lumbago, defecation pain, dyspareunia, and pain on internal examination)
• The presence of objective findings (induration in the pouch of Douglas and/or limited uterine mobility).
• Subject is on stable therapy regimen for at least 8 weeks prior to screening period
• Subjects able and willing to comply with the requirements of the protocol
• Subjects able to understand and sign written informed consent to participate in the study

Exclusion Criteria

• Undiagnosed genital bleeding
• Class 3 or more pap test within 3 months before enrollment
• Use of GnRH agonist, testosterone derivatives, hormonal therapy with progesterone and/or estrogen, estrogen antagonists or aromatase inhibitors within 16 weeks before enrollment
• Having undergone surgery therapy or surgical examination for endometriosis within menstrual cycle before the start of medication
• Use of drugs that could be expected to affect the release of sex hormones (e.g. sulpiride, cimetidine)
• A history or complication or finding of thrombosis/embolism or depression
• Malignant tumor complication or finding suggestive of a malignant tumor
• Complication of serious heart, liver, kidney, blood or endocrine disease
• Participation in another clinical trial within 4 months before enrollment
• Patients deemed unsuitable for study entry by the investigator
• Subject with other severe pain due to other conditions that may confound assessment or self-evaluation of the pain associated with endometriosis
• Subject with serious cardiovascular, hepatic, renal, respiratory, gastrointestinal, urological, neurological, endocrine, autoimmune or hematological disease, malignancy not considered cured (except for BCC) or clinically significant laboratory or electrocardiogram abnormality which indicate a serious medical problem or require significant intervention in the judgment of the investigator
• Current systemic infection
• Subject with a diagnosis of social phobia, generalized anxiety disorder, bipolar disorder, psychosis, major depressive disorder or schizoaffective disorder; or any other disorder with psychotic symptoms - based on the clinical opinion of the investigator.
• Subject with personality disorder or mental retardation
• Subjects with known allergy to one or more of the study drug components
• Female subject who is pregnant, lactating, or who want to get pregnant during the study period
• Female of child-bearing potential who can't agree to utilize medically acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study
• Subject with a history of alcohol or any psychoactive substance abuse or dependence (including alcohol, but excluding nicotine and caffeine) within the past 1 year
• Subject receiving opiates or cannabis therapy
• Patients with first degree siblings with significant mental or psychiatric disorder or a psychiatric disease (especially patients less than 30 years old)
• Subject who are using one of the following medications: Opiates, Primidone, Phenobarbitol, Carbamazepine, Rifampicin, Rifabutin, Troglitazone and Hypericum perforatum

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; sublingual drops
Experimental: BOL-DP-o-08	Drug: BOL-DP-o-08; BOL-DP-o-08 sublingual drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in a pain Numeric Rating Scale	The Visual Analogue Scale (VAS) is a Numeric Rating Scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers)	Baseline to week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Global Impression	Clinical Global Impression is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients)	Baseline to week 16
Changes in the size of endometrial ovarian cysts and endometrial nodules	measured by gynecological Ultrasound examination	Baseline to week 16

Collaborators and Investigators

• Sponsor: Breath of Life International Pharma Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: BOL-P-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No