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Trial Title:
Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation
NCT ID:
NCT05491343
Condition:
Arteriovenous Malformations
Conditions: Official terms:
Hemangioma
Arteriovenous Malformations
Congenital Abnormalities
Medroxyprogesterone Acetate
Medroxyprogesterone
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MedroxyPROGESTERone Injection [Depo-Provera]
Description:
The drug-induced endometrial changes would likely to prevent the shedding of endometrium,
in turn preventing the exposure of AVM.
Arm group label:
Progesterone treatment
Intervention type:
Device
Intervention name:
Other
Description:
Follow up using US
Arm group label:
Progesterone treatment
Summary:
A randomized trial which compares conservative management to progesterone based treatment
for arteriovenous malformation
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
No
Start date:
August 2022
Completion date:
January 2024
Lead sponsor:
Agency:
HaEmek Medical Center, Israel
Agency class:
Other
Source:
HaEmek Medical Center, Israel
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05491343
