Abnormal Uterine BleedingPhase 2FEATSNCT05227456
Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study
A Phase 2 study testing Etonogestrel 68mg implant in people with Abnormal Uterine Bleeding and Dysmenorrhea, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormal Uterine Bleeding, Dysmenorrhea
- What is being tested?
- Etonogestrel 68mg implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2022to 30 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Previous endometrial ablation
- Pelvic pain and/or vaginal bleeding seeking treatment
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Abnormal Uterine Bleeding, Dysmenorrhea
- Being tested
- Etonogestrel 68mg implant
- Keywords
- abnormal uterine bleeding, pain, dysmenorrhea, endometrial ablation
- Medical subject headings
- Metrorrhagia, Dysmenorrhea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etonogestrel 68mg implantDrug
Also called Nexplanon
Implant will be inserted
Etonogestrel 68mg implantDevice
Also called Nexplanon
Implant will be inserted
| Study group | Role | What they receive |
|---|---|---|
| Etonogestrel implant | Experimental | The participants will receive an etonogestrel 68mg implant Receives: Drug: Etonogestrel 68mg implant; Device: Etonogestrel 68mg implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hysterectomy
occurrence of hysterectomy
Measured: Occurrence of hysterectomy will be documented any time during the 3 year follow up period
Secondary outcomes (3)
Vaginal bleeding
Pictorial Blood Loss Assessment Chart (PBAC) score, minimum score = 0mL, maximum score = n/a, higher score indicates higher menstrual blood loss
Measured: 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
Measured: 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
Measured: Time of hysterectomy will be documented any time during the 3 year follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Jul 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Why it stopped: Difficulty in Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saskatchewan Health Authority - Regina Area
- Sponsor type
- University, hospital or other
- Collaborators
- University of Saskatchewan
- Responsible party
- Principal investigator, Sarah Smith, Saskatchewan Health Authority - Regina Area
- Investigators
- Sarah N Smith, MD, Principal investigator, Obstetrician Gynecologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227456
- Sponsor's protocol ID
- REB-22-05
- Acronym
- FEATS
- Status last verified
- Nov 2025
- First submitted
- 26 Jan 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study
- ClinicalTrials.gov ID
- NCT05227456
- Acronym / sponsor ID
- FEATS / REB-22-05
- Conditions
- Abnormal Uterine Bleeding, Dysmenorrhea
- Keywords
- abnormal uterine bleeding, pain, dysmenorrhea, endometrial ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in Recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Saskatchewan Health Authority - Regina AreaUniversity, hospital or other
- Collaborators
- University of Saskatchewan
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etonogestrel implant | Experimental | Drug: Etonogestrel 68mg implant, Device: Etonogestrel 68mg implantThe participants will receive an etonogestrel 68mg implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous endometrial ablation
- Pelvic pain and/or vaginal bleeding seeking treatment
Key exclusion criteria (7 listed)
- Previous or current VTE
- Liver tumour, benign or malignant, or active liver disease
- Undiagnosed abnormal genital bleeding
- Known or suspected breast cancer
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etonogestrel 68mg implantAlso: NexplanonImplant will be inserted | Drug | Etonogestrel implant |
| Etonogestrel 68mg implantAlso: NexplanonImplant will be inserted | Device | Etonogestrel implant |
Primary outcome
Hysterectomy
Time frame: Occurrence of hysterectomy will be documented any time during the 3 year follow up period
occurrence of hysterectomy
3 secondary outcomes
Vaginal bleeding
Time frame: PBAC score will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months
Pelvic Pain
Time frame: VAS will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months
Time to Hysterectomy
Time frame: Time of hysterectomy will be documented any time during the 3 year follow up period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah N Smith, MD principal investigator
Obstetrician Gynecologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etonogestrel 68mg implant in people with Abnormal Uterine Bleeding and Dysmenorrhea, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hysterectomy (time frame: Occurrence of hysterectomy will be documented any time during the 3 year follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.