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

NCT04174911 | Withdrawn Phase 1

• 1 other identifier: BOL-P-09
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Clinical Global Impression

  Baseline to week 16

• Changes in the size of endometrial ovarian cysts and endometrial nodules

  Baseline to week 16

Study Arms (2)

BOL-DP-o-08

EXPERIMENTAL

BOL-DP-o-08

Drug: BOL-DP-o-08

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

BOL-DP-o-08 DRUG

BOL-DP-o-08 sublingual drops

BOL-DP-o-08

Placebo DRUG

sublingual drops

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Breath of Life International Pharma Ltd: lead

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 22, 2019
• Study Start: January 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share