Cabergoline for the Treatment of Chronic Pain Due to Endometriosis

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.

Conditions

Endometriosis

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Study Overview

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Study Details

Study overview

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.

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

Cabergoline for the Treatment of Chronic Pain Due to Endometriosis

Condition
Endometriosis
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Standford University, Palo Alto, California, United States, 94305

Aurora

Childrens Hospital Colorado, Aurora, Colorado, United States, 80045

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02115

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Boston

Children's Hospital Boston, Boston, Massachusetts, United States, 02115

Philadelphia

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States, 19107

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

15 Years to 40 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Children's Hospital,

Study Record Dates

2026-06