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

Boston Children's Hospital

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: Norethindrone acetate; Drug: Cabergoline

Study type: Interventional

Funder types: Other

Identifiers

NCT02542410

P00018628

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups

Control

Active Comparator group

Description:

Norethindrone acetate 5 mg po daily x 6 months

Treatment:

Drug: Norethindrone acetate

Experimental

Experimental group

Description:

cabergoline 0.5 mg PO twice weekly x 6 months

Treatment:

Drug: Cabergoline