Cabergoline for the Treatment of Chronic Pain Due to Endometriosis
CompletedPhase 2NCT03928288
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Novel, Non-Hormonal Therapy for the Treatment of Chronic Pain Due to Endometriosis in Adolescent and Adult Women
- Conditions
- Interventions
- Drug: Cabergoline 0.5 MG
- Drug: Placebo - Cap
- Sponsor
- Boston Children's Hospital
- Collaborators
- Beth Israel Deaconess Medical Center; Thomas Jefferson University; Stanford University; Children's Hospital Colorado; Brigham and Women's Hospital
- Start date
- 2019-12-02
- Primary completion
- 2026-01-14
- Sex
- Female
- Age range
- from 15 Years to 40 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 6
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03928288