Hyivy Device for Endometriosis

(endometriosis Trial)

Overseen By Mathew Leonardi, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hyivy Health Inc

Must be taking: Hormonal medications

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Vaginal infections, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the Hyivy device, which is designed to help reduce pelvic pain. The study focuses on people with endometriosis, a condition that causes significant pelvic pain. The device likely uses physical therapy methods to ease this pain.

Do I need to stop my current medications for the trial?

You do not need to stop your current hormonal medications for endometriosis, but you must not start any new treatments during the 12-week study. You should also avoid taking non-steroidal anti-inflammatory drugs (like ibuprofen) for 72 hours before certain study visits.

Research Team

Mathew Leonardi, M.D.

Principal Investigator

McMaster University Medical Centre

Eligibility Criteria

This trial is for adults over 18 with endometriosis and chronic pelvic pain lasting more than 3 months. Participants must be in good health otherwise, have been managing endometriosis with hormones for at least 3 months, and be willing to use an intravaginal device. They can't start new treatments or physiotherapy during the study, nor have conditions like active infections or recent surgeries that could interfere.

Inclusion Criteria

Must be willing and able to insert intravaginal device

I have been treating my endometriosis with hormones non-stop for 3 months.

Agrees not to commence any new treatments for the 12-week intervention period

Exclusion Criteria

You are allergic to the materials used in the Hyivy device.

I do not have an active vaginal infection.

I am currently taking antibiotics and have had yeast infections before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Hyivy intravaginal device at home, three times per week for 12 weeks

12 weeks

Baseline, 6-week, and 12-week assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Hyivy device

Trial Overview The Hyivy device is being tested to see if it reduces self-reported pelvic pain in individuals with endometriosis. The study involves participants using this intravaginal device regularly and monitoring their pain levels without starting any other new treatments.

Participant Groups

Group I: Hyivy Intravaginal Device Experimental Treatment 1 Intervention

Participants will receive a Hyivy intravaginal device for at-home use. Recommended use is three times per week for 12 weeks and consists of 10 minutes of heat (37-39ºC) and 10 minutes of dilation per session.

Who Is Running the Clinical Trial?

Hyivy Health Inc

Lead Sponsor

Trials

2

Recruited

30+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+