Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

Dysmenorrhea Clinical Trial

— FEATS  

Official title:

Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227456
• Other study ID #: REB-22-05
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: November 2023
• Source: Saskatchewan Health Authority - Regina Area
• Contact: Sarah N Smith, MD
• Phone: 306-352-4963
• Email: SarahSmith[@]saskhealthauthority.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 97
• Est. completion date: June 30, 2027
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Dysmenorrhea
• Hemorrhage
• Uterine Hemorrhage

Intervention

Drug:
• Etonogestrel 68mg implant
Implant will be inserted

Device:
• Etonogestrel 68mg implant
Implant will be inserted

Locations

Country	Name	City	State
Canada	Saskatchewan Health Authority	Regina	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
Saskatchewan Health Authority - Regina Area	University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hysterectomy	occurrence of hysterectomy	Occurrence of hysterectomy will be documented any time during the 3 year follow up period
Secondary	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
Secondary	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
Secondary	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