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

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cabergoline
Norethindrone acetate
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Norethindrone acetate 5 mg po daily x 6 months

cabergoline 0.5 mg PO twice weekly x 6 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2015
Last Updated
January 27, 2020
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02542410
Brief Title
Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study
Official Title
Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Norethindrone acetate 5 mg po daily x 6 months
Arm Title
Experimental
Arm Type
Experimental
Arm Description
cabergoline 0.5 mg PO twice weekly x 6 months
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Other Intervention Name(s)
Dostinex
Intervention Type
Drug
Intervention Name(s)
Norethindrone acetate
Other Intervention Name(s)
Aygestin
Primary Outcome Measure Information:
Title
Change in Score in Worst Pain Over the Last Month
Description
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.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Changes in Pain Interference Scores
Description
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
Time Frame
Baseline, 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34934987
Citation
DiVasta AD, Stamoulis C, Gallagher JS, Laufer MR, Anchan R, Hornstein MD. Nonhormonal therapy for endometriosis: a randomized, placebo-controlled, pilot study of cabergoline versus norethindrone acetate. F S Rep. 2021 Jul 24;2(4):454-461. doi: 10.1016/j.xfre.2021.07.003. eCollection 2021 Dec.
Results Reference
derived

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

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