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

Breath of Life Pharma

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Endometriosis

Treatments

Drug: BOL-DP-o-08

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04174911

BOL-P-09

Details and patient eligibility

About

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

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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