Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation

HaEmek Medical Center, Israel

Status and phase: Not yet enrolling; Phase 4

Conditions: Arteriovenous Malformations

Treatments: Device: Other; Drug: MedroxyPROGESTERone Injection [Depo-Provera]

Study type: Interventional

Funder types: Other

Identifiers

NCT05491343

0060-22EMC

Details and patient eligibility

About

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

Enrollment: 28 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Conservative management

No Intervention group

Progesterone treatment

Experimental group

Treatment:

Drug: MedroxyPROGESTERone Injection [Depo-Provera]

Device: Other