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FEATS: Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

Sponsor
Saskatchewan Health Authority - Regina Area (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05227456
Collaborator
University of Saskatchewan (Other)
97
Enrollment
1
Arm
60
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The objective of this study is to assess the efficacy of an implantable etonogestrel device in reducing hysterectomy rate in patients with a failed endometrial ablation.

Condition or Disease Intervention/Treatment Phase
  • Drug: Etonogestrel 68mg implant
  • Device: Etonogestrel 68mg implant
 Phase 2

Detailed Description

The researchers aim to determine whether use of etonogestrel implant in patients with failed endometrial ablation significantly decreases hysterectomy rate. Changes in pelvic pain and vaginal bleeding will be assessed. Time to hysterectomy will be examined.

The researchers hypothesize that treatment of failed endometrial ablation with etonogestrel implant will decrease pelvic pain and vaginal bleeding resulting in a significantly decreased need for hysterectomy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
97 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Jun 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Etonogestrel implant

The participants will receive an etonogestrel 68mg implant

Drug: Etonogestrel 68mg implant
Implant will be inserted
Other Names:
  • Nexplanon

    • Device: Etonogestrel 68mg implant
    Implant will be inserted
    Other Names:
  • Nexplanon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hysterectomy [Occurrence of hysterectomy will be documented any time during the 3 year follow up period]

      occurrence of hysterectomy

    Secondary Outcome Measures

    1. Vaginal bleeding [PBAC score will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months]

      Pictorial Blood Loss Assessment Chart (PBAC) score, minimum score = 0mL, maximum score = n/a, higher score indicates higher menstrual blood loss

    2. Pelvic Pain [VAS will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months]

      Assessment of pelvic pain using Visual Analogue Scale (VAS), minimum score = 0, maximum score = 10, higher score indicates more pain

    3. Time to Hysterectomy [Time of hysterectomy will be documented any time during the 3 year follow up period]

      Time from booking of hysterectomy to actual hysterectomy will be documented

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Previous endometrial ablation

    • Pelvic pain and/or vaginal bleeding seeking treatment

    Exclusion Criteria:

    • Previous or current VTE

    • Liver tumour, benign or malignant, or active liver disease

    • Undiagnosed abnormal genital bleeding

    • Known or suspected breast cancer

    • Uncontrolled hypertension

    • Allergy to component of etonogestrel implant

    • Lack of patient consent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Saskatchewan Health Authority - Regina Area
    • University of Saskatchewan

    Investigators

    • Principal Investigator: Sarah N Smith, MD, Obstetrician Gynecologist

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sarah Smith, Obstetrician Gynecologist, Principal Investigator, Assistant Professor, Saskatchewan Health Authority - Regina Area
    ClinicalTrials.gov Identifier:
    NCT05227456
    Other Study ID Numbers:
    • REB-22-05
    First Posted:
    Feb 7, 2022
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Sarah Smith, Obstetrician Gynecologist, Principal Investigator, Assistant Professor, Saskatchewan Health Authority - Regina Area
    abnormal uterine bleeding
    pain
    dysmenorrhea
    endometrial ablation
    Additional relevant MeSH terms:
    Uterine Hemorrhage
    Hemorrhage
    Dysmenorrhea
    Etonogestrel
    Desogestrel

    Study Results

    No Results Posted as of Jun 15, 2022