NCT03928288CompletedPhase 2
Cabergoline for the Treatment of Chronic Pain Due to Endometriosis
Novel, Non-Hormonal Therapy for the Treatment of Chronic Pain Due to Endometriosis in Adolescent and Adult Women
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 129 (actual)
- First submitted
- 4 Apr 2019
- Start date
- 2 Dec 2019
- Primary completion date
- 14 Jan 2026
- Lead sponsor
- Boston Children's Hospital
- Diseases
- Endometriosis
- NCT number
- NCT03928288
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 129
- From 2 Dec 2019 to the primary completion date, 14 Jan 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Breast cancer, current or previous
- Thromboembolic disease, current or previous
- Use of other drugs that affect dopamine (e.g., phenothiazines, metoclopramide, butyrophenones)
Other illness
- 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
Lab values
- Impaired liver function (ALT \> 2x normal) or liver disease
Other
- Pre-menarche or post-menopause
- Pregnant, breastfeeding, or planning to become pregnant in the next 6 months
Who the study is looking for
- 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
Age in the registry: 15 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Childrens Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Children's Hospital, Boston Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Standford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.