Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

NCT05227456 | Withdrawn Phase 2 FDA Drug FDA Device

• 1 other identifier: REB-22-05
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormal Uterine Bleeding; Dysmenorrhea

Keywords

abnormal uterine bleeding; pain; dysmenorrhea; endometrial ablation

Outcome Measures

Primary Outcomes (1)

• Hysterectomy

  occurrence of hysterectomy

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

Secondary Outcomes (3)

• Vaginal bleeding

  PBAC score will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months

• Pelvic Pain

  VAS will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months

• Time to Hysterectomy

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

Study Arms (1)

Etonogestrel implant

EXPERIMENTAL

The participants will receive an etonogestrel 68mg implant

Drug: Etonogestrel 68mg implant; Device: Etonogestrel 68mg implant

Interventions

Etonogestrel 68mg implant DRUG

Implant will be inserted

Also known as: Nexplanon

Etonogestrel implant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous endometrial ablation
• Pelvic pain and/or vaginal bleeding seeking treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Saskatchewan Health Authority - Regina Area: lead
• University of Saskatchewan: collaborator

Study Sites (1)

Saskatchewan Health Authority

Regina, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Metrorrhagia; Dysmenorrhea; Pain

Interventions

etonogestrel; Drug Implants; Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations; Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Officials

• Sarah N Smith, MD

  Obstetrician Gynecologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician Gynecologist, Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: July 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

CA (1)