Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation
Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05491343
Collaborator
(none)
28
2
17
Study Details
Study Description
Brief Summary
A randomized trial which compares conservative management to progesterone based treatment for arteriovenous malformation
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Management of Uterine Arteriovenous Malformation- a Comparison of 2 Management Possibilities- Observation vs. Progesterone Treatment/ a Randomized Control Trial
Anticipated Study Start Date
:
Aug 1, 2022
Anticipated Primary Completion Date
:
Dec 1, 2022
Anticipated Study Completion Date
:
Jan 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Conservative management
|
|
| Experimental: Progesterone treatment
|
Drug: MedroxyPROGESTERone Injection [Depo-Provera]
The drug-induced endometrial changes would likely to prevent the shedding of endometrium, in turn preventing the exposure of AVM.
Device: Other
Follow up using US
|
Outcome Measures
Primary Outcome Measures
- AVM regression [3 weeks]
The time from diagnosis to regression
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- HaEmek Medical Center, Israel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Etty Spiegel,
Dr.,
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT05491343
Other Study ID Numbers:
- 0060-22EMC
First Posted:
Aug 8, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms: