Back to resultsObservation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation
Primary Purpose
Arteriovenous Malformations
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MedroxyPROGESTERone Injection [Depo-Provera]
Other
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Malformations
Eligibility Criteria
Inclusion Criteria:
- women between age of 18 to 50, diagnosed with AVM
- hemodynamically stable at clinical presentation
Exclusion Criteria:
- unstable patients
- contraindication to treatment
- US examination not in the US department
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conservative management
Progesterone treatment
Arm Description
Outcomes
Primary Outcome Measures
AVM regression
The time from diagnosis to regression
Secondary Outcome Measures
Full Information
NCT ID
NCT05491343
First Posted
August 4, 2022
Last Updated
August 4, 2022
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT05491343
Brief Title
Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation
Official Title
Management of Uterine Arteriovenous Malformation- a Comparison of 2 Management Possibilities- Observation vs. Progesterone Treatment/ a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
A randomized trial which compares conservative management to progesterone based treatment for arteriovenous malformation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Malformations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conservative management
Arm Type
No Intervention
Arm Title
Progesterone treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MedroxyPROGESTERone Injection [Depo-Provera]
Intervention Description
The drug-induced endometrial changes would likely to prevent the shedding of endometrium, in turn preventing the exposure of AVM.
Intervention Type
Device
Intervention Name(s)
Other
Intervention Description
Follow up using US
Primary Outcome Measure Information:
Title
AVM regression
Description
The time from diagnosis to regression
Time Frame
3 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women between age of 18 to 50, diagnosed with AVM
hemodynamically stable at clinical presentation
Exclusion Criteria:
unstable patients
contraindication to treatment
US examination not in the US department
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation
We'll reach out to this number within 24 hrs