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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542410
• Other study ID #: P00018628
• Status: Completed
• Phase: Phase 2
• Start date: May 2016
• Est. completion date: September 2018

Study information

• Verified date: January 2020
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Cabergoline

• Norethindrone acetate

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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