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Dopamine Agonist

Cabergoline for Endometriosis

Phase 2
Recruiting
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 15 years to 40 years
Current pelvic pain (score ≥ 3 on Visual Analog Scale, where 0 represents absence of pain and 10 indicates unbearable pain) present for ≥ 14 days/month over the 2 months prior to study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks for 6 months
Awards & highlights

Study Summary

This trial is testing whether a existing drug, cabergoline, can be repurposed as a safe, alternative angiogenesis inhibitor for adolescents and young women with endometriosis.

Who is the study for?
This trial is for females aged 15-40 with surgically confirmed endometriosis and chronic pelvic pain. Participants must have been on hormonal therapy for at least 2 months and be willing to follow the study's schedule. It excludes those who are pre-menarche, post-menopause, pregnant, or planning pregnancy soon; have certain heart, lung, liver conditions; breast cancer history; blood clots; or use specific dopamine-affecting drugs.Check my eligibility
What is being tested?
The trial tests Cabergoline as a potential non-hormonal treatment for endometriosis-related pain by inhibiting new blood vessel growth that supports the condition. It's a randomized double-blind study comparing Cabergoline against a placebo to evaluate its effectiveness in reducing pelvic pain.See study design
What are the potential side effects?
Cabergoline may cause side effects like nausea, headache, dizziness, fatigue, dry mouth or constipation due to its action on dopamine pathways. Heart valve issues could also arise but are more relevant to individuals with contraindications which are excluded from this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 15 and 40 years old.
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I have had pelvic pain rated 3 or higher for most days in the last 2 months.
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I am a woman with endometriosis confirmed by surgery.
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I have been using hormonal therapy like birth control pills or devices for over 2 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks for 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks for 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Change in pain measured by Biberoglu and Behrman patient ratings scale (B&B pain scale) over 6 months
Change in pain severity measured by Visual Analog Scale (VAS) over 6 months
Secondary outcome measures
Change in cardiovascular dysfunction measured by pulse wave velocity over 6 months
Change in measurements of serum biomarkers of angiogenesis and inflammation over 6 months
Change in measures of central hypersensitization measured by quantitative sensory testing at 6 months
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Cabergoline 0.5 mg PO twice weekly for 6 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsule PO twice weekly for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabergoline
FDA approved

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,590 Total Patients Enrolled
6 Trials studying Endometriosis
2,999 Patients Enrolled for Endometriosis
Brigham and Women's HospitalOTHER
1,612 Previous Clinical Trials
11,470,435 Total Patients Enrolled
4 Trials studying Endometriosis
2,091 Patients Enrolled for Endometriosis
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,090 Total Patients Enrolled

Media Library

Endometriosis Research Study Groups: Intervention, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the therapeutic purpose of Cabergoline 0.5 MG?

"Cabergoline 0.5 MG is a well-known medicine used to suppress lactation, as well as for treating pituitary adenoma and idiopathic hyperprolactinemic disorder remedies."

Answered by AI

Is Cabergoline 0.5 MG associated with any adverse effects?

"Considering the Phase 2 trial status of Cabergoline 0.5 MG, our team at Power assessed its safety as a score of 2 since there is only limited clinical data to prove efficacy but some demonstrating security."

Answered by AI

How many individuals are actively participating in this clinical experiment?

"Indeed, clinicaltrials.gov confirms that this medical research is actively enrolling participants since it was first listed on December 2nd 2019. 80 patients will be recruited from two different centres and the information has been recently updated as of September 15th 2022."

Answered by AI

Are there any vacancies for individuals interested in taking part in this experimentation?

"Affirmative, information hosted on clinicaltrials.gov illustrates that this medical trial is actively seeking out new candidates; it was first posted on December 2nd 2019, and has been updating since September 15th 2022. Currently the study requires 80 participants from two separate sites to enrol in the experiment."

Answered by AI

Is this research recruiting elderly participants?

"This study necessitates that potential participants be between 15 and 40 years of age."

Answered by AI

May I enroll in the investigation?

"This research seeks to recruit 80 individuals with endometrioma within the age range of 15-40 years. Moreover, participants must have been using hormonal therapy for at least two months prior, be able to prove a diagnosis of endometriosis through surgery, report pelvic pain on Visual Analog Scale that is equal or higher than 3 out of 10 for at least 14 days in the 2 months before enrollment and agree to follow study guidelines."

Answered by AI

Is this the inaugural attempt of a clinical trial like this?

"At present, six Cabergoline 0.5 MG trials are ongoing in 41 cities and 30 countries around the world. The initial clinical trial for this drug was funded by RECORDATI GROUP in 2013; it had a sample size of 413 participants and accomplished Phase 4 approval. In total, 43 studies have been conducted since then."

Answered by AI

What key objectives does this trial aspire to accomplish?

"The primary metric of the study, which will be assessed every 6 weeks for 6 months, is a change in pain severity as evaluated by Visual Analog Scale (VAS). Additionally, secondary outcomes include incidence of vaginal bleeding over a half-year period and changes in serum concentrations of high sensitivity C-reactive protein, interleukins 1B and 8, tumor necrosis factor alpha ,and vascular endothelial growth factor. Finally, central hypersensitization can be measured via quantitative sensory testing at the abdomen."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Children's Hospital Boston
Thomas Jefferson University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Since I was diagnosed, I haven't had any luck with medications or any sort of treatment for that matter.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Children's Hospital Boston: < 48 hours
Average response time
  • < 2 Days
~8 spots leftby Aug 2024