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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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for endometriosis primarily include hormonal therapies and non-hormonal options. Hormonal treatments such as GnRH analogs, oral contraceptives, and progestins work by suppressing ovarian hormone production, thereby reducing the growth and maintenance of endometrial tissue. Non-hormonal treatments like NSAIDs help manage pain but do not address the underlying disease. Angiogenesis inhibitors, such as the drug Cabergoline being studied in clinical trials, target the formation of new blood vessels that endometriotic lesions need to grow. This approach is particularly promising as it offers a non-hormonal, non-surgical option that could be safer for reproductive-age women, potentially reducing pain and disease progression without the side effects associated with hormonal therapies.
State of the art, new treatment strategies, and emerging drugs for non-hormonal treatment of endometriosis: a systematic review of randomized control trials.Selective modulation of the prostaglandin F2α pathway markedly impacts on endometriosis progression in a xenograft mouse model.

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER
2,408 Previous Clinical Trials
17,343,267 Total Patients Enrolled
2 Trials studying Endometriosis
86 Patients Enrolled for Endometriosis
Boston Children's HospitalLead Sponsor
768 Previous Clinical Trials
5,580,379 Total Patients Enrolled
6 Trials studying Endometriosis
2,999 Patients Enrolled for Endometriosis
Brigham and Women's HospitalOTHER
1,622 Previous Clinical Trials
11,468,604 Total Patients Enrolled
4 Trials studying Endometriosis
2,091 Patients Enrolled for Endometriosis

Media Library

Endometriosis Research Study Groups: Intervention, Placebo
~42 spots leftby Jun 2026
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