Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

Phase 2

Terminated

• Conditions: Dysmenorrhea; Abnormal Uterine Bleeding
• Interventions: Device: Etonogestrel 68mg implant

• Registration Number: NCT05227456
• Lead Sponsor: Saskatchewan Health Authority - Regina Area

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.

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-07
• Study Start: 2022-07-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etonogestrel implant	Etonogestrel 68mg implant	The participants will receive an etonogestrel 68mg implant

Primary Outcome Measures

Name	Time	Method
Hysterectomy	Occurrence of hysterectomy will be documented any time during the 3 year follow up period	occurrence of hysterectomy

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Saskatchewan Health Authority; 🇨🇦 Regina, Saskatchewan, Canada