Hyivy Device as Non-hormonal Therapy in Endometriosis (endometriosis)

September 11, 2025 updated by: Hyivy Health Inc

Evaluation of the Hyivy Device as a Non-hormonal Therapy in People With Endometriosis

This study seeks to address accessible management of endometriosis-associated chronic pelvic pain by evaluating a novel device used in the home. The study is designed as a proof-of-concept single-arm pilot study, and the primary objective is to assess change in overall self-reported pelvic pain in people with endometriosis-associated chronic pelvic pain following the use of the Hyivy intravaginal device.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Endometriosis is a chronic, inflammatory, estrogen-dependent disease characterized by ectopic growth of uterine-like cells outside the uterus. People living with endometriosis typically experience debilitating pelvic pain (dysmenorrhea, dyspareunia, dyschezia, dysuria, non-menstrual pelvic pain), and infertility. Endometriosis also has significant negative impacts on quality of life, physical, mental, and social wellbeing.

There is no diagnostic marker nor cure for this chronic disease. Current treatment options include medical therapies (mainly hormonal treatments aimed at suppressing menstruation or growth of the ectopic cells), surgery (to remove endometriotic lesions/nodules), and complementary or alternative therapies (non-medical or surgical options to manage symptoms; heat, mindfulness, diet, yoga, natural remedies, physical therapies, etc.).

Many people living with endometriosis report having used self-management strategies (complementary and alternative therapies) to manage their symptoms, and research on treatments and alternative therapies are consistently ranked among the top endometriosis research priorities. Alternative therapies have the potential to complement existing medical and surgical therapies, offering additional options to manage symptoms like pain.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1.Age ≥ 18 at the time of enrollment
  • 2.Generally in good health (other than due to endometriosis), at physician's discretion
  • 3.Diagnosed with endometriosis (clinical, radiologic, or surgical)
  • 4.Diagnosed with chronic pelvic pain (self-reported pain in pelvic area lasting >3 months)
  • 5.VAS for overall pelvic pain ≥ 4 at screening and baseline
  • 6.Medically managing endometriosis using continuous hormonal medications (i.e., oral contraceptive pills, progesterone only pills, Mirena, GnRH agonists/antagonists) for at least 3 months prior to enrollment
  • 7.Agrees not to commence any new treatments (medical or physical therapies) for the 12-week intervention period, including hormonal therapies for any medical condition, and complimentary and/or alternative management of surgery for endometriosis and associated chronic pain
  • 8.Agrees not to undergo pelvic physiotherapy with a trained professional during the study
  • 9.Agrees to avoid taking non-steroidal anti-inflammatory drugs (e.g., ibuprofen) for 72 hours before Visits 1, 2, and 3
  • 10.Must have the ability to charge the investigational device
  • 11.Must be willing and able to insert intravaginal device
  • 12.Able to understand, comply and consent to protocol requirements and instructions
  • 13.Able to attend scheduled study visits and complete required investigations

Exclusion Criteria:

  • 1.Chronic pelvic pain thought to be due to a condition other than endometriosis
  • 2.Diagnosis of premature ovarian insufficiency
  • 3.Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational product or that may affect the interpretation of the results or leave the patient at high risk from treatment complications, at the discretion of the investigator(s)
  • 4.Any surgery in the past 3 months or anticipates having surgery during the study
  • 5.Allergy to Hyivy device's materials
  • 6.Active vaginal infection (e.g. vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, STIs) or infection in the pelvic area
  • 7.Current use of antibiotics and a history of vulvovaginal candidiasis
  • 8.Pregnant or lactating
  • 9.Currently under the care of a pelvic floor physiotherapist
  • 10.Have open wounds, cuts, or open sores present in vaginal or pelvic area
  • 11.Severe atrophic vaginitis or very dry, itchy, or sore vagina/vaginal area, at the discretion of the primary investigator(s)
  • 12.Hypoesthesia or loss in sensation of the pelvic floor
  • 13.Total and/or partial prolapse of the uterus and/or vagina
  • 14.Symptoms of severe urinary retention, severe extra-urethral incontinence or overflow incontinence
  • 15.Unable to position the device according to directions for use
  • 16.Use of any medical devices that may interfere with the investigational device's function, such as pacemakers, ventilators, and ear implants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyivy Intravaginal Device
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.
Device: Hyivy Intravaginal Device
Intravaginal use of Hyivy device three times per week for 12 weeks, with each session consisting of 10 minutes of heat (37-39ºC) and 10 minutes of dilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall self-reported pelvic pain
Time Frame: Baseline, 6-weeks, 12-weeks
Overall pelvic pain will be evaluated using a digital visual analog scale (VAS)
Baseline, 6-weeks, 12-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Site-specific tenderness and pelvic floor muscle pain
Time Frame: Baseline, 6-weeks, 12-weeks
Site-specific tenderness and pelvic floor muscle pain will be measured by the Biberoglu and Behrman scale (B&B) ranging from 0 (none) to 15 (severe) and patient exams
Baseline, 6-weeks, 12-weeks
Quality of Life (EHP-30)
Time Frame: Baseline, 6-weeks, 12-weeks
Changes in quality of life as assessed by the Endometriosis Health Profile-30 (EHP-30) ranging from 0 (best possible health status) to 100 (worst possible health status).
Baseline, 6-weeks, 12-weeks
Sexual Function (FSFI)
Time Frame: Baseline, 6-weeks, 12-weeks
Changes in sexual function as assessed by the Female Sexual Function Index (FSFI). Scores range from 2 to 36 with higher scores indicating greater functioning.
Baseline, 6-weeks, 12-weeks
Safety and tolerability of the Hyivy device
Time Frame: Up to 12-weeks
Occurrence of adverse events (AE) and serious adverse events (SAE).
Up to 12-weeks
Adherence to study protocol
Time Frame: 6-weeks, 12-weeks
Usage data collected by the Hyivy device will be used to assess participant adherence to the study regimen of 3 times/week device use.
6-weeks, 12-weeks
Feasibility of the Hyivy device
Time Frame: 6-weeks, 12-weeks
Device usage will be assessed with a study-specific questionnaire.
6-weeks, 12-weeks
Use of rescue medication
Time Frame: Baseline, 6-weeks, 12-weeks
Changes in the use of rescue medications for chronic pelvic pain, assessed with a study-specific questionnaire.
Baseline, 6-weeks, 12-weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic function
Time Frame: Baseline, 6-weeks, 12-weeks
Autonomic nervous system (ANS) function will be assessed using measures of heart rate variability (HRV) during a deep breathing test, active standing test, and water intake test.
Baseline, 6-weeks, 12-weeks
Peripheral gene expression
Time Frame: Baseline, 6-weeks, 12-weeks
Changes in peripheral inflammation as assessed by a protein biomarker panel before and after device use
Baseline, 6-weeks, 12-weeks
Emergency room (ER) visits
Time Frame: Baseline, 6-weeks, 12-weeks
Number of ER visits due to chronic pelvic pain in the last 6 weeks
Baseline, 6-weeks, 12-weeks
Device usability and patient satisfaction
Time Frame: 12-weeks
Study-specific questionnaire to gather patient feedback
12-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyivy Health Inc

Collaborators

McMaster University

Investigators

  • Principal Investigator: Mathew Leonardi, M.D., McMaster University Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYV-001-C23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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