COMPLETED

Cabergoline for the Treatment of Chronic Pain Due to Endometriosis

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-12-02
Study Completion:2026-01-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03928288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female with surgically-confirmed endometriosis
  2. * Age 15 years to 40 years
  3. * Current use ≥ 2 months duration of hormonal therapy such as combined oral contraceptives, norethindrone acetate, or levonorgestrel intrauterine device
  4. * 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
  5. * Willingness to comply with visit schedule and protocol
  1. * Pre-menarche or post-menopause
  2. * Contraindications to cabergoline (e.g., cardiac valve disorder; pulmonary, pericardial, retroperitoneal fibrotic disorder; hypersensitivity to ergot derivatives; uncontrolled hypertension)
  3. * Significant mental or chronic systemic illness that might confound pain assessment or the ability to complete the study
  4. * Pregnant, breastfeeding, or planning to become pregnant in the next 6 months
  5. * Impaired liver function (ALT \> 2x normal) or liver disease
  6. * Breast cancer, current or previous
  7. * Thromboembolic disease, current or previous
  8. * Use of other drugs that affect dopamine (e.g., phenothiazines, metoclopramide, butyrophenones)

Contacts and Locations

Study Locations (Sites)

Standford University
Palo Alto, California, 94305
United States
Childrens Hospital Colorado
Aurora, Colorado, 80045
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Children's Hospital Boston
Boston, Massachusetts, 02115
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-02
Study Completion Date2026-01-14

Study Record Updates

Study Start Date2019-12-02
Study Completion Date2026-01-14

Terms related to this study

Additional Relevant MeSH Terms

  • Endometriosis