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

Study Overview
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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.

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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Cabergoline
* Drug: Norethindrone acetate


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Norethindrone acetate 5 mg po daily x 6 months | Drug: Norethindrone acetate<br> <br> * Other names: Aygestin;|
| Experimental: Experimental<br>cabergoline 0.5 mg PO twice weekly x 6 months | Drug: Cabergoline<br> <br> * Other names: Dostinex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Score in Worst Pain Over the Last Month | 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. | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pain Interference Scores | Brief Pain Inventory Interference subscale is a 7-item self-report measure, designed to assess the extent to which pain interferes with various components of functioning, including physical and emotional functioning and sleep.The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assess the extent to which pain interferes with sleep. The arithmetic mean of the seven interference items is used as a measure of pain interference (i.e., how much a participant's pain interferes with her ability to complete activities of daily living and functioning). The score on the pain interference subscale ranges from 0-70. Higher scores are worse outcomes. Outcome measure calculated as the value at 6 months minus the value at baseline | Baseline, 6 months |