Using cabergoline to treat chronic pain from endometriosis

Novel, Non-Hormonal Therapy for the Treatment of Chronic Pain Due to Endometriosis in Adolescent and Adult Women

This study is testing if cabergoline can help young women and girls with endometriosis feel less pelvic pain when other treatments haven't worked.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 15 Years to 40 Years
• Sex: Female
• Sponsor: Boston Children's Hospital (other)
• Locations: 6 sites (Palo Alto, California and 5 other locations)
• Trial ID: NCT03928288 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of cabergoline, a repurposed drug, as a non-hormonal and non-surgical treatment for chronic pain associated with endometriosis. The study will involve a randomized, double-blind design where participants will receive either cabergoline or a placebo. The focus is on alleviating severe pelvic pain in young women and adolescents who have been diagnosed with endometriosis and have not found relief from existing treatments. By targeting angiogenesis, the trial seeks to provide a new therapeutic option for a condition that currently has limited effective treatments.

Who should consider this trial

Good fit: Ideal candidates are females aged 15 to 40 with surgically-confirmed endometriosis and significant pelvic pain.

Not a fit: Patients who are pre-menarche, post-menopausal, or have contraindications to cabergoline will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a safe and effective alternative for managing chronic pain in patients with endometriosis.

How similar studies have performed: While the approach of repurposing cabergoline is novel for this specific application, similar studies targeting angiogenesis have shown promise in other contexts.

Eligibility criteria

Inclusion Criteria:

* Female with surgically-confirmed endometriosis
* Age 15 years to 40 years
* Current use ≥ 2 months duration of hormonal therapy such as combined oral contraceptives, norethindrone acetate, or levonorgestrel intrauterine device
* 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
* Willingness to comply with visit schedule and protocol

Exclusion Criteria:

* Pre-menarche or post-menopause
* Contraindications to cabergoline (e.g., cardiac valve disorder; pulmonary, pericardial, retroperitoneal fibrotic disorder; hypersensitivity to ergot derivatives; uncontrolled hypertension)
* Significant mental or chronic systemic illness that might confound pain assessment or the ability to complete the study
* Pregnant, breastfeeding, or planning to become pregnant in the next 6 months
* Impaired liver function (ALT \> 2x normal) or liver disease
* Breast cancer, current or previous
* Thromboembolic disease, current or previous
* Use of other drugs that affect dopamine (e.g., phenothiazines, metoclopramide, butyrophenones)

Where this trial is running

Palo Alto, California and 5 other locations

• Standford University — Palo Alto, California, United States (RECRUITING)
• Childrens Hospital Colorado — Aurora, Colorado, United States (RECRUITING)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
• Children's Hospital Boston — Boston, Massachusetts, United States (RECRUITING)
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Study coordinator: Esther Kim

Conditions: Endometriosis