Novel, Non-Hormonal Therapy for the Treatment of Chronic Pain Due to Endometriosis in Adolescent and Adult Women
Abstract
Endometriosis afflicts millions of women worldwide, resulting in the loss of academic, athletic, social, and professional success. Women can experience chronic pain, fertility challenges, and higher risk of cardiovascular disease. As no cure exists, patients require disease management across the lifespan. However, current therapies are suboptimal, and pain is often left untreated. Medications with favorable long-term safety, efficacy, and tolerability are desperately needed. As endometriosis is dependent on angiogenesis for its growth and maintenance, we believe that angiogenesis inhibitors are a promising option for treatment. However, these medications have not yet been studied since the currently approved angiogenesis inhibitors induce severe side effects and are teratogenic, making them inappropriate for use in reproductive-age women. We will overcome this obstacle by repurposing an existing drug (cabergoline) that has an acceptable safety profile as an angiogenesis inhibitor to treat chronic pelvic pain associated with endometriosis. Hypothesis/Objectives: We propose to conduct a randomized, double-blind, placebo controlled trial to determine the efficacy of cabergoline as an adjunct treatment for persistent pain due to endometriosis. Specific Aims: (1) To determine the extent to which cabergoline adjunct treatment alleviates persistent pelvic pain suffered by women with laparoscopically-proven endometriosis. We hypothesize that after 6 months, subjects randomized to cabergoline (n=40) will demonstrate decreased pain measures, improved functional disability scores, and increased quality of life scores compared to baseline and to subjects randomized to placebo (n=40). (2) To measure the impact of cabergoline on inflammation, angiogenesis, and cardiovascular risk in endometriosis.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2023
- Accession Number
- AD1219298
Entities
People
- Amy D. Divasta
Organizations
- Boston Children's Hospital