Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

Conditions
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Abnormal Uterine Bleeding, Dysmenorrhea

Intervention / Treatment
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* Drug: Etonogestrel 68mg implant
* Device: Etonogestrel 68mg implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etonogestrel implant<br>The participants will receive an etonogestrel 68mg implant | Drug: Etonogestrel 68mg implant<br>* Implant will be inserted<br>* Other names: Nexplanon;Device: Etonogestrel 68mg implant<br>* Implant will be inserted<br>* Other names: Nexplanon;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, abnormal uterine bleeding, dysmenorrhea, endometrial ablation