Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedResults Posted
Study results publicly available
February 5, 2020
CompletedFebruary 5, 2020
January 1, 2020
2.3 years
August 11, 2015
January 14, 2020
January 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Changes in Pain Interference Scores
Baseline, 6 months
Study Arms (2)
Control
ACTIVE COMPARATORNorethindrone acetate 5 mg po daily x 6 months
Experimental
EXPERIMENTALcabergoline 0.5 mg PO twice weekly x 6 months
Interventions
Eligibility Criteria
You may qualify if:
- Surgically confirmed endometriosis
- Age between 15-40 y, and premenopausal
- Pelvic pain score ≥3 on a Visual Analog Scaleover the last month
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 34934987DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- DR. AMY DIVASTA
- Organization
- BOSTON CHILDREN'S HOSPITAL
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 11, 2015
First Posted
September 7, 2015
Study Start
May 1, 2016
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
February 5, 2020
Results First Posted
February 5, 2020
Record last verified: 2020-01