What side effects are associated with this type of intervention?

Common treatments for endometriosis include hormonal therapies like dienogest and norethindrone acetate, which can cause side effects such as weight gain, mood changes, and decreased bone density. GnRH agonists and antagonists may lead to menopausal symptoms like hot flashes, vaginal dryness, and decreased bone density. Levonorgestrel intrauterine devices (LNG IUDs) can cause irregular bleeding and hormonal side effects. Cabergoline, an angiogenesis inhibitor being studied for endometriosis, is generally well-tolerated but can cause nausea, dizziness, and headaches.

What prior FDA approvals exist?

Currently, there are no FDA-approved angiogenesis inhibitors specifically for the treatment of endometriosis. Most treatments for endometriosis focus on hormonal therapies, such as GnRH agonists, oral contraceptives, and progestins, or surgical interventions. The trial studying Cabergoline aims to repurpose this drug as a non-hormonal, non-surgical angiogenesis inhibitor, which would be a novel approach for managing endometriosis-related pain.

What other types of research exist?

Promising novel alternatives to Cabergoline for endometriosis treatment include NK3R antagonists and kappa receptor agonists. These agents have shown potential in reducing LH and testosterone levels, which are relevant to endometriosis management. Additionally, ongoing research into other angiogenesis inhibitors with fewer side effects may provide new options.

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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

Must not have

Use of other drugs that affect dopamine (e.g., phenothiazines, metoclopramide, butyrophenones)

Pre-menarche or post-menopause

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 weeks for 6 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial is testing cabergoline, a medication that stops new blood vessels from forming, to see if it can reduce pain in adolescents and young women with endometriosis. Current treatments often don't work well or have too many side effects. Cabergoline may offer a safer, long-term solution by preventing the growth of new blood vessels needed for endometriosis to grow. Cabergoline has shown promise in early studies for treating chronic pain due to 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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking medications that affect dopamine.

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I have not started menstruating or I am post-menopausal.

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I don't have heart valve issues, fibrosis, allergies to certain migraine medications, or uncontrolled high blood pressure.

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My liver isn't working well (ALT levels are high).

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I have or had breast cancer.

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I have had blood clots in the past or have them now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 weeks for 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

0 / 10Eligibility criteria met

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.