Phase 2 N=10 Randomized Quadruple-blind Treatment

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

Endometriosis

Bottom Line

View on ClinicalTrials.gov: NCT02542410 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: Change in Score in Worst Pain Over the Last Month — -0.5; -5 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cabergoline (Drug); Norethindrone acetate (Drug)
Age: Pediatric, Adult · 15+ yrs
Sex: Female
Sponsor: Boston Children's Hospital
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Score in Worst Pain Over the Last Month	-0.5; -5	—
SECONDARY Changes in Pain Interference Scores	0.85; 0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02542410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.