EndometriosisPhase 1/2NCT04174911
A Study to Evaluate the Safety and Efficacy of BOL-DP-o-08 in Patients With Endometriosis Syndrome.
A Phase 1/2 study testing BOL-DP-o-08 in people with Endometriosis, run by Breath of Life International Pharma Ltd.
Trial summary
A Phase 2a, Single-center, randomized, double-blind, placebo-controlled study, in 80 subjects diagnosed with Endometriosis, stage 2-4 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- BOL-DP-o-08
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Dec 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
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- 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
About this study
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.
A Phase 2a, Single-center, randomized, double-blind, placebo-controlled study, in 80 subjects diagnosed with Endometriosis, stage 2-4
Read the 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
- Endometriosis
- Being tested
- BOL-DP-o-08, Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOL-DP-o-08Drug
BOL-DP-o-08 sublingual drops
PlaceboDrug
sublingual drops
| Study group | Role | What they receive |
|---|---|---|
| BOL-DP-o-08 | Experimental | BOL-DP-o-08 Receives: Drug: BOL-DP-o-08 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to week 16
Secondary outcomes (2)
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)
Measured: Baseline to week 16
Changes in the size of endometrial ovarian cysts and endometrial nodules
measured by gynecological Ultrasound examination
Measured: Baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study startJan 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: covid 19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breath of Life International Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174911
- Sponsor's protocol ID
- BOL-P-09
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2019
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04174911
- Acronym / sponsor ID
- BOL-P-09
- Conditions
- Endometriosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: covid 19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Breath of Life International Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOL-DP-o-08 | Experimental | Drug: BOL-DP-o-08BOL-DP-o-08 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOL-DP-o-08BOL-DP-o-08 sublingual drops | Drug | BOL-DP-o-08 |
| Placebosublingual drops | Drug | Placebo |
Primary outcome
Change in a pain Numeric Rating Scale
Time frame: Baseline to week 16
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)
2 secondary outcomes
Change in Clinical Global Impression
Time frame: Baseline to week 16
Changes in the size of endometrial ovarian cysts and endometrial nodules
Time frame: Baseline to week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BOL-DP-o-08 in people with Endometriosis, run by Breath of Life International Pharma Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in a pain Numeric Rating Scale (time frame: Baseline to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.