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Progestin

Progesterone Implant for Abnormal Uterine Bleeding (FEATS Trial)

Phase 2

Recruiting

Led By Sarah N Smith, MD

Research Sponsored by Saskatchewan Health Authority - Regina Area

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pelvic pain and/or vaginal bleeding seeking treatment

Previous endometrial ablation

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

FEATS Trial Summary

This trialaims to see if an implant reduces the need for hysterectomy after failed endometrial ablation.

Who is the study for?

This trial is for individuals who have had an endometrial ablation procedure that didn't work and are now experiencing pelvic pain or vaginal bleeding. It's not suitable for those with a history of blood clots, liver tumors or disease, undiagnosed abnormal genital bleeding, breast cancer, uncontrolled high blood pressure, or allergies to the etonogestrel implant.Check my eligibility

What is being tested?

The FEAT Study is testing whether an implantable device that releases etonogestrel (a hormone) can reduce the need for hysterectomy in patients whose endometrial ablation treatment failed to stop abnormal uterine bleeding and/or menstrual cramps.See study design

What are the potential side effects?

Possible side effects of the etonogestrel implant may include changes in menstrual periods, mood swings, weight gain, headache, acne, breast pain, and potential site reactions where the device is implanted.

FEATS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am experiencing pelvic pain or vaginal bleeding and seeking treatment.

Select...

I have had a procedure to remove the lining of my uterus.

FEATS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of hysterectomy will be documented any time during the 3 year follow up period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of hysterectomy will be documented any time during the 3 year follow up period

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of hysterectomy will be documented any time during the 3 year follow up period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hysterectomy

Secondary outcome measures

Pelvic Pain

Time to Hysterectomy

Vaginal bleeding

FEATS Trial Design

1Treatment groups

Experimental Treatment

Group I: Etonogestrel implantExperimental Treatment1 Intervention

The participants will receive an etonogestrel 68mg implant

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Saskatchewan Health Authority - Regina AreaLead Sponsor

27 Previous Clinical Trials

5,421 Total Patients Enrolled

University of SaskatchewanOTHER

251 Previous Clinical Trials

154,313 Total Patients Enrolled

Sarah N Smith, MDPrincipal InvestigatorObstetrician Gynecologist

Media Library

Etonogestrel 68mg implant (Progestin) Clinical Trial Eligibility Overview. Trial Name: NCT05227456 — Phase 2

Abnormal Uterine Bleeding Research Study Groups: Etonogestrel implant

Abnormal Uterine Bleeding Clinical Trial 2023: Etonogestrel 68mg implant Highlights & Side Effects. Trial Name: NCT05227456 — Phase 2

Etonogestrel 68mg implant (Progestin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05227456 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Etonogestrel implant achieved authorization from the Food and Drug Administration?

"Our research team at Power assigned a score of 2 to Etonogestrel implant in terms of safety, given that the Phase 2 trial has collected data on its security but none with regards to efficacy."

Answered by AI

What is the participant count for this investigation?

"Affirmative. According to clinicaltrials.gov, this study is actively seeking participants with 97 patients being sought from a single medical site. The investigation was initially posted on July 1st 2022 and has since been modified as of October 24th 2022."

Answered by AI

Are there any openings available for prospective participants?

"Clinicaltrials.gov confirms that this medical trial is recruiting volunteers, which began on the 1st of July 2022 and was recently updated at the end of October 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

Sarah Smith 2022. "Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05227456.

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