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

Boston Children's Hospital1 site in 1 country10 target enrollmentMay 2016

ConditionsEndometriosis

InterventionsNorethindrone acetate Cabergoline

DrugsCabergoline Norethindrone acetate

Overview

Phase: Phase 2
Intervention: Norethindrone acetate
Conditions: Endometriosis
Sponsor: Boston Children's Hospital
Enrollment: 10
Locations: 1
Primary Endpoint: Change in Score in Worst Pain Over the Last Month
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

September 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Boston Children's Hospital

Responsible Party

Principal Investigator

Amy DiVasta, MD

Principal Investigator

Boston Children's Hospital

Eligibility 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

Arms & Interventions

Control

Norethindrone acetate 5 mg po daily x 6 months

Intervention: Norethindrone acetate

Experimental

cabergoline 0.5 mg PO twice weekly x 6 months

Intervention: Cabergoline

Outcomes

Primary Outcomes

Change in Score in Worst Pain Over the Last Month

Time Frame: Baseline, 6 months

visual analog scale, minimum=0 and maximum=10 Higher numbers are a worse outcome Outcome measures is calculated as the value at 6 months minus value at baseline.