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

Saskatchewan Health Authority

Status and phase: Withdrawn; Phase 2

Conditions: Dysmenorrhea; Abnormal Uterine Bleeding

Treatments: Device: Etonogestrel 68mg implant

Study type: Interventional

Funder types: Other

Identifiers

NCT05227456

REB-22-05

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Etonogestrel implant

Experimental group

Description:

The participants will receive an etonogestrel 68mg implant

Treatment:

Device: Etonogestrel 68mg implant

Device: Etonogestrel 68mg implant