Cabergoline for the Treatment of Chronic Pain Due to Endometriosis

NCT03928288 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: P00031528
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (3)

• Change in pain assessed by the Brief Pain Inventory Interference Scale (BPI) over 6 months

  BPI: A 7-item self-report measure. The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assesses the extent to which pain interferes with sleep. Either the item asking about the "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference. The BPI is anchored between a scale of zero (no pain/interference) to ten (maximum pain/interference). The magnitude of treatment-associated change in BPI Interference Scale scores in open-label and randomized clinical trials ranges from 1 to 3 points, depending on the specific pain conditions and treatments studied.

  every 6 weeks for 6 months

• Change in pain severity measured by Visual Analog Scale (VAS) over 6 months

  VAS: A measurement of pain intensity, assessed by a 0 to 10 numerical rating scale, to rate maximum and average pain intensity over the preceding 7 days. Higher scores indicate more severe pain intensity.

  every 6 weeks for 6 months

• Change in pain measured by Biberoglu and Behrman patient ratings scale (B&B pain scale) over 6 months

  Biberoglu and Behrman patient ratings scale (B\&B pain scale): Survey that assesses dyspareunia, dysmenorrhea, and noncyclic pelvic pain. Each is graded on a scale from 0 to 3 (or 4), with higher numbers indicating more severe symptoms.

  every 6 weeks for 6 months

Secondary Outcomes (4)

• Change in measurements of serum biomarkers of angiogenesis and inflammation over 6 months

  every 3 months for 6 months

• Change in cardiovascular dysfunction measured by pulse wave velocity over 6 months

  baseline and 6 months

• Change in measures of central hypersensitization measured by quantitative sensory testing at 6 months

  every 3 months for 6 months

• Incidence of vaginal bleeding over 6 months

  completed daily for 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Cabergoline 0.5 mg PO twice weekly for 6 months

Drug: Cabergoline 0.5 MG

Placebo

PLACEBO COMPARATOR

Placebo capsule PO twice weekly for 6 months

Drug: Placebo - Cap

Interventions

Cabergoline 0.5 MG DRUG

Medication

Also known as: Dostinex

Intervention

Placebo - Cap DRUG

Placebo capsule

Placebo

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator
• Thomas Jefferson University: collaborator
• Stanford University: collaborator
• Children's Hospital Colorado: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (6)

Standford University

Palo Alto, California, 94305, United States

Location

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 26, 2019
• Study Start: December 2, 2019
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (6)