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

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: Recruiting
• Conditions: Dysmenorrhea; Abnormal Uterine Bleeding
• Intervention / Treatment: Drug: Etonogestrel 68mg implant; Device: Etonogestrel 68mg implant

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
• Enrollment (Estimated): 97
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sarah N Smith, MD; Phone Number: 306-352-4963; Email: SarahSmith@saskhealthauthority.ca

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada
      • Recruiting
      • Saskatchewan Health Authority
      • Contact: Sarah Smith, MD; Email: sarahsmith@saskhealthauthority.ca

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	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 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

• Sponsor: Saskatchewan Health Authority - Regina Area
• Collaborators: University of Saskatchewan
• Investigators: Principal Investigator: Sarah N Smith, MD, Obstetrician Gynecologist

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): June 30, 2027

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 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pain; dysmenorrhea; abnormal uterine bleeding; endometrial ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Uterine Diseases; Menstruation Disturbances; Pelvic Pain; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Hemorrhage; Dysmenorrhea; Uterine Hemorrhage; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Desogestrel; Etonogestrel
• 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