Cabergoline for the Treatment of Chronic Pain Due to Endometriosis

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Endometriosis is dependent on angiogenesis (the sprouting of new blood vessels) for its growth and maintenance, but the side effects of currently approved angiogenesis inhibitors make these agents inappropriate for use in reproductive-age patients. This obstacle will be overcome by performing a randomized, double blind clinical trial aimed at repurposing an existing drug, cabergoline, as a safe, alternative angiogenesis inhibitor for adolescents and young women with endometriosis. This trial proposes a novel, non-hormonal, non-surgical therapeutic approach aimed at alleviating the pain and suffering associated with this common chronic disease that currently has limited treatment options.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborator: Brigham and Women's Hospital
• Treatments: Cabergoline

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)