Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation

Phase 4

• Conditions: Arteriovenous Malformations
• Interventions: Drug: MedroxyPROGESTERone Injection [Depo-Provera]; Device: Other

• Registration Number: NCT05491343
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

A randomized trial which compares conservative management to progesterone based treatment for arteriovenous malformation

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08
• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-04
• Last Update Submitted: 2022-08-04
• Study First Posted: 2022-08-08
• Last Update Posted: 2022-08-08
• Primary Completion: 2022-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone treatment	MedroxyPROGESTERone Injection [Depo-Provera]	-
Progesterone treatment	Other	-

Primary Outcome Measures

Name	Time	Method
AVM regression	3 weeks	The time from diagnosis to regression