Failed Endometrial Ablation Treatment With Implantable Pr... | NCT05227456

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

NCT05227456

Sponsor

Saskatchewan Health Authority - Regina Area

Status

Withdrawn

Last Update Posted

Nov 25, 2025Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Abnormal Uterine Bleeding
Dysmenorrhea

Interventions

Etonogestrel 68mg implant
Etonogestrel 68mg implant

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in Recruitment

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Apr 30, 2024Actual

Completion Date

Apr 30, 2024Actual

First Submitted Date

Jan 26, 2022

First Submission Date that Met QC Criteria

Jan 26, 2022

First Posted Date

Feb 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2025

Last Update Posted Date

Nov 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sarah Smith, Obstetrician Gynecologist, Principal Investigator, Assistant Professor, Saskatchewan Health Authority - Regina AreaPrincipal Investigator

Lead Sponsor

Saskatchewan Health Authority - Regina AreaOTHER

Collaborators

Name	Class
University of Saskatchewan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Etonogestrel implant	Experimental	The participants will receive an etonogestrel 68mg implant	Drug: Etonogestrel 68mg implant Device: Etonogestrel 68mg implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etonogestrel 68mg implant	Drug	Implant will be inserted	Etonogestrel implant

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Vaginal bleeding	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah N Smith, MD	Obstetrician Gynecologist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saskatchewan Health Authority		Regina	Saskatchewan		Canada

Condition Browse Module

MeSH Terms

ID	Term
D008796	Metrorrhagia
D004412	Dysmenorrhea
D010146	Pain

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C044815	etonogestrel
D004343	Drug Implants
D016254	Mutagenesis, Insertional

Ancestor Terms

ID	Term
D003692	Delayed-Action Preparations
D004304	Dosage Forms
D004364	Pharmaceutical Preparations
D015202	Protein Engineering

Browse Leaves

Not provided

Browse Branches

Not provided