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

November 19, 2025 updated by: Sarah Smith, Saskatchewan Health Authority - Regina Area
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • Saskatchewan Health Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hysterectomy
Time Frame: Occurrence of hysterectomy will be documented any time during the 3 year follow up period
occurrence of hysterectomy
Occurrence of hysterectomy will be documented any time during the 3 year follow up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal bleeding
Time Frame: 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
PBAC score will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months
Pelvic Pain
Time Frame: 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
VAS will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months
Time to Hysterectomy
Time Frame: 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
Time of hysterectomy will be documented any time during the 3 year follow up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saskatchewan Health Authority - Regina Area

Collaborators

University of Saskatchewan

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Estimated)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB-22-05

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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