Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent, cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of endometriosis-associated pain in young women with endometriosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Cabergoline; Dopamine; Dopamine Agonists; Norethindrone; Norethindrone Acetate

Criteria

Inclusion Criteria:

• Surgically confirmed endometriosis

• Age between 15-40 y, and premenopausal

• Pelvic pain score ≥3 on a Visual Analog Scaleover the last month

Exclusion Criteria:

• Use of other concurrent hormone medications (such as birth control pills)

• Impaired liver function (ALT > 2x normal) or liver disease (cirrhosis, hepatitis)

• Pregnancy

• Breast cancer

• Active thromboembolic disease

• Uncontrolled hypertension, history of cardiac valve disorder, history of fibrotic disorders