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Observation 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
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriovenous Malformations

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

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

    First Posted
    August 4, 2022
    Last Updated
    August 4, 2022
    Sponsor
    HaEmek Medical Center, Israel
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    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

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