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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Norethindrone acetate 5 mg po daily x 6 months

Group Type ACTIVE_COMPARATOR

Norethindrone acetate

Intervention Type DRUG

Experimental

cabergoline 0.5 mg PO twice weekly x 6 months

Group Type EXPERIMENTAL

Cabergoline

Intervention Type DRUG

Interventions

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Cabergoline

Intervention Type DRUG

Norethindrone acetate

Intervention Type DRUG

Other Intervention Names

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Dostinex Aygestin

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No