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

Primary Purpose

Abnormal Uterine Bleeding, Dysmenorrhea

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Etonogestrel 68mg implant

About this trial

This is an interventional treatment trial for Abnormal Uterine Bleeding focused on measuring abnormal uterine bleeding, pain, dysmenorrhea, endometrial ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Saskatchewan Health AuthorityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Etonogestrel implant

Arm Description

The participants will receive an etonogestrel 68mg implant

Outcomes

Primary Outcome Measures

Hysterectomy

occurrence of hysterectomy

Secondary Outcome Measures

Vaginal bleeding

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

Pelvic Pain

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

Time to Hysterectomy

Time from booking of hysterectomy to actual hysterectomy will be documented

Full Information

NCT ID

NCT05227456

First Posted

January 26, 2022

Last Updated

October 24, 2022

Sponsor

Saskatchewan Health Authority - Regina Area

Collaborators

University of Saskatchewan

1. Study Identification

Unique Protocol Identification Number

NCT05227456

Brief Title

Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

Acronym

FEATS

Official Title

Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Saskatchewan Health Authority - Regina Area

Collaborators

University of Saskatchewan

4. Oversight

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

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abnormal Uterine Bleeding, Dysmenorrhea

Keywords

abnormal uterine bleeding, pain, dysmenorrhea, endometrial ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

97 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Etonogestrel implant

Arm Type

Experimental

Arm Description

The participants will receive an etonogestrel 68mg implant

Intervention Type

Drug

Intervention Name(s)

Etonogestrel 68mg implant

Other Intervention Name(s)

Nexplanon

Intervention Description

Implant will be inserted

Intervention Type

Device

Intervention Name(s)

Etonogestrel 68mg implant

Other Intervention Name(s)

Nexplanon

Intervention Description

Implant will be inserted

Primary Outcome Measure Information:

Title

Hysterectomy

Description

occurrence of hysterectomy

Time Frame

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

Secondary Outcome Measure Information:

Title

Vaginal bleeding

Description

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

Title

Pelvic Pain

Description

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

Title

Time to Hysterectomy

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah N Smith, MD

Phone

306-352-4963

SarahSmith@saskhealthauthority.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah N Smith, MD

Organizational Affiliation

Obstetrician Gynecologist

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saskatchewan Health Authority

City

Regina

State/Province

Saskatchewan

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Smith, MD

sarahsmith@saskhealthauthority.ca

12. IPD Sharing Statement

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Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

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