Progesterone Implant for Abnormal Uterine Bleeding (FEATS Trial)

Phase 2

Waitlist Available

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

Must not have

Previous or current VTE

Undiagnosed abnormal genital bleeding

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a blood clot in the past or have one now.

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I have unexplained bleeding from my genital area.

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My high blood pressure is not under control.

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I have a liver tumor or active liver disease.

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I have or might have breast cancer.

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.