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WithdrawnNCT05227456FEATSUpdated Nov 25, 2025

Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

A Phase 2 interventional study of Etonogestrel 68mg implant and Etonogestrel 68mg implant in Abnormal Uterine Bleeding and Dysmenorrhea, sponsored by Saskatchewan Health Authority - Regina Area. Withdrawn at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Saskatchewan Health Authority - Regina Area · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Difficulty in Recruitment
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Abnormal Uterine Bleeding
  • Dysmenorrhea

Keywords

  • abnormal uterine bleeding
  • pain
  • dysmenorrhea
  • endometrial ablation
03

In context

Metrorrhagia

95 studies on the registry are indexed under Metrorrhagia; 24 are open to participants now.

Browse Metrorrhagia studies →

Lead sponsor

Saskatchewan Health Authority - Regina Area is the lead sponsor of 19 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Previous endometrial ablation
  • Pelvic pain and/or vaginal bleeding seeking treatment

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Etonogestrel implant

    The participants will receive an etonogestrel 68mg implant

    Drug: Etonogestrel 68mg implant · Device: Etonogestrel 68mg implant

Interventions

  • DrugEtonogestrel 68mg implant

    Implant will be inserted

    Also known as: Nexplanon

  • DeviceEtonogestrel 68mg implant

    Implant will be inserted

    Also known as: Nexplanon

06

What researchers measure

Primary outcomes

  1. Hysterectomy

    occurrence of hysterectomy

    Time frame: Occurrence of hysterectomy will be documented any time during the 3 year follow up period

Secondary outcomes

  1. Vaginal bleeding

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

    Time frame: PBAC score will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months

  2. Pelvic Pain

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

    Time frame: VAS will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months

  3. Time to Hysterectomy

    Time from booking of hysterectomy to actual hysterectomy will be documented

    Time frame: Time of hysterectomy will be documented any time during the 3 year follow up period

07

Study locations

1 site
  • Saskatchewan Health Authority
    Regina, Saskatchewan, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05227456
Lead sponsor
Saskatchewan Health Authority - Regina Area
Collaborators
University of Saskatchewan
Responsible party
Sarah Smith (Obstetrician Gynecologist, Principal Investigator, Assistant Professor, Saskatchewan Health Authority - Regina Area) — Principal investigator
First posted
Feb 7, 2022
Start date
Jul 1, 2022
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024
Last update
Nov 25, 2025

Study contacts

Sarah N Smith, MD
principal investigator · Obstetrician Gynecologist

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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