EndometriosisNCT05643131
Hyivy Device as Non-hormonal Therapy in Endometriosis
A study testing Hyivy Intravaginal Device in people with Endometriosis and Pelvic Pain, run by Hyivy Health Inc at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Pelvic Pain
- What is being tested?
- Hyivy Intravaginal Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometriosis, Pelvic Pain
- Being tested
- Hyivy Intravaginal Device
- Keywords
- Endometriosis, Pelvic Pain, Dilator
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyivy Intravaginal DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyivy Intravaginal Device | Experimental | 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. Receives: Device: Hyivy Intravaginal Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall self-reported pelvic pain
Overall pelvic pain will be evaluated using a digital visual analog scale (VAS)
Measured: Baseline, 6-weeks, 12-weeks
Secondary outcomes (7)
Site-specific tenderness and pelvic floor muscle pain
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
Measured: Baseline, 6-weeks, 12-weeks
Quality of Life (EHP-30)
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).
Measured: Baseline, 6-weeks, 12-weeks
Sexual Function (FSFI)
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.
Measured: Baseline, 6-weeks, 12-weeks
Safety and tolerability of the Hyivy device
Occurrence of adverse events (AE) and serious adverse events (SAE).
Measured: Up to 12-weeks
Adherence to study protocol
Usage data collected by the Hyivy device will be used to assess participant adherence to the study regimen of 3 times/week device use.
Measured: 6-weeks, 12-weeks
Feasibility of the Hyivy device
Device usage will be assessed with a study-specific questionnaire.
Measured: 6-weeks, 12-weeks
Use of rescue medication
Changes in the use of rescue medications for chronic pelvic pain, assessed with a study-specific questionnaire.
Measured: Baseline, 6-weeks, 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study startOct 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational pre/post repeated-measures pilot intervention study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyivy Health Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Mathew Leonardi, M.D., Principal investigator, McMaster University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643131
- Sponsor's protocol ID
- HYV-001-C23
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2022
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Singh S, Soliman AM, Rahal Y, Robert C, Defoy I, Nisbet P, Leyland N. Prevalence, Symptomatic Burden, and Diagnosis of Endometriosis in Canada: Cross-Sectional Survey of 30 000 Women. J Obstet Gynaecol Can. 2020 Jul;42(7):829-838. doi: 10.1016/j.jogc.2019.10.038. Epub 2020 Jan 27.
PubMed 32001176Kong S, Zhang YH, Liu CF, Tsui I, Guo Y, Ai BB, Han FJ. The complementary and alternative medicine for endometriosis: a review of utilization and mechanism. Evid Based Complement Alternat Med. 2014;2014:146383. doi: 10.1155/2014/146383. Epub 2014 Feb 19.
PubMed 24701237Vercellini P, Vigano P, Somigliana E, Fedele L. Endometriosis: pathogenesis and treatment. Nat Rev Endocrinol. 2014 May;10(5):261-75. doi: 10.1038/nrendo.2013.255. Epub 2013 Dec 24.
PubMed 24366116Becker CM, Gattrell WT, Gude K, Singh SS. Reevaluating response and failure of medical treatment of endometriosis: a systematic review. Fertil Steril. 2017 Jul;108(1):125-136. doi: 10.1016/j.fertnstert.2017.05.004.
PubMed 28668150As-Sanie S, Black R, Giudice LC, Gray Valbrun T, Gupta J, Jones B, Laufer MR, Milspaw AT, Missmer SA, Norman A, Taylor RN, Wallace K, Williams Z, Yong PJ, Nebel RA. Assessing research gaps and unmet needs in endometriosis. Am J Obstet Gynecol. 2019 Aug;221(2):86-94. doi: 10.1016/j.ajog.2019.02.033. Epub 2019 Feb 18.
PubMed 30790565Duffy J, Hirsch M, Vercoe M, Abbott J, Barker C, Collura B, Drake R, Evers J, Hickey M, Horne AW, Hull ML, Kolekar S, Lensen S, Johnson NP, Mahajan V, Mol BW, Otter AS, Puscasiu L, Rodriguez MB, Rombauts L, Vail A, Wang R, Farquhar CM; endo:outcomes - an International Collaboration Harmonising Outcomes and Outcome Measures for Endometriosis Research. A core outcome set for future endometriosis research: an international consensus development study. BJOG. 2020 Jul;127(8):967-974. doi: 10.1111/1471-0528.16157. Epub 2020 Mar 30.
PubMed 32227676Nnoaham KE, Hummelshoj L, Webster P, d'Hooghe T, de Cicco Nardone F, de Cicco Nardone C, Jenkinson C, Kennedy SH, Zondervan KT; World Endometriosis Research Foundation Global Study of Women's Health consortium. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011 Aug;96(2):366-373.e8. doi: 10.1016/j.fertnstert.2011.05.090. Epub 2011 Jun 30.
PubMed 21718982
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hyivy Device as a Non-hormonal Therapy in People With Endometriosis
- ClinicalTrials.gov ID
- NCT05643131
- Acronym / sponsor ID
- HYV-001-C23
- Conditions
- Endometriosis, Pelvic Pain
- Keywords
- Endometriosis, Pelvic Pain, Dilator
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hyivy Health IncIndustry (pharma, biotech, devices)
- Collaborators
- McMaster University
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Dec 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational pre/post repeated-measures pilot intervention study
| Arm | Type | Receives |
|---|---|---|
| Hyivy Intravaginal Device | Experimental | Device: Hyivy Intravaginal DeviceParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| Hyivy Intravaginal DeviceIntravaginal 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. | Device | Hyivy Intravaginal Device |
Primary outcome
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)
7 secondary outcomes
Site-specific tenderness and pelvic floor muscle pain
Time frame: Baseline, 6-weeks, 12-weeks
Quality of Life (EHP-30)
Time frame: Baseline, 6-weeks, 12-weeks
Sexual Function (FSFI)
Time frame: Baseline, 6-weeks, 12-weeks
Safety and tolerability of the Hyivy device
Time frame: Up to 12-weeks
Adherence to study protocol
Time frame: 6-weeks, 12-weeks
Feasibility of the Hyivy device
Time frame: 6-weeks, 12-weeks
Use of rescue medication
Time frame: Baseline, 6-weeks, 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 32001176Singh S, Soliman AM, Rahal Y, Robert C, Defoy I, Nisbet P, Leyland N. Prevalence, Symptomatic Burden, and Diagnosis of Endometriosis in Canada: Cross-Sectional Survey of 30 000 Women. J Obstet Gynaecol Can. 2020 Jul;42(7):829-838. doi: 10.1016/j.jogc.2019.10.038. Epub 2020 Jan 27.
- Background: PubMed 24701237Kong S, Zhang YH, Liu CF, Tsui I, Guo Y, Ai BB, Han FJ. The complementary and alternative medicine for endometriosis: a review of utilization and mechanism. Evid Based Complement Alternat Med. 2014;2014:146383. doi: 10.1155/2014/146383. Epub 2014 Feb 19.
- Background: PubMed 24366116Vercellini P, Vigano P, Somigliana E, Fedele L. Endometriosis: pathogenesis and treatment. Nat Rev Endocrinol. 2014 May;10(5):261-75. doi: 10.1038/nrendo.2013.255. Epub 2013 Dec 24.
- Background: PubMed 28668150Becker CM, Gattrell WT, Gude K, Singh SS. Reevaluating response and failure of medical treatment of endometriosis: a systematic review. Fertil Steril. 2017 Jul;108(1):125-136. doi: 10.1016/j.fertnstert.2017.05.004.
- Background: PubMed 30790565As-Sanie S, Black R, Giudice LC, Gray Valbrun T, Gupta J, Jones B, Laufer MR, Milspaw AT, Missmer SA, Norman A, Taylor RN, Wallace K, Williams Z, Yong PJ, Nebel RA. Assessing research gaps and unmet needs in endometriosis. Am J Obstet Gynecol. 2019 Aug;221(2):86-94. doi: 10.1016/j.ajog.2019.02.033. Epub 2019 Feb 18.
- Background: PubMed 32227676Duffy J, Hirsch M, Vercoe M, Abbott J, Barker C, Collura B, Drake R, Evers J, Hickey M, Horne AW, Hull ML, Kolekar S, Lensen S, Johnson NP, Mahajan V, Mol BW, Otter AS, Puscasiu L, Rodriguez MB, Rombauts L, Vail A, Wang R, Farquhar CM; endo:outcomes - an International Collaboration Harmonising Outcomes and Outcome Measures for Endometriosis Research. A core outcome set for future endometriosis research: an international consensus development study. BJOG. 2020 Jul;127(8):967-974. doi: 10.1111/1471-0528.16157. Epub 2020 Mar 30.
- Background: PubMed 21718982Nnoaham KE, Hummelshoj L, Webster P, d'Hooghe T, de Cicco Nardone F, de Cicco Nardone C, Jenkinson C, Kennedy SH, Zondervan KT; World Endometriosis Research Foundation Global Study of Women's Health consortium. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011 Aug;96(2):366-373.e8. doi: 10.1016/j.fertnstert.2011.05.090. Epub 2011 Jun 30.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
Mathew Leonardi, M.D. principal investigator
McMaster University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyivy Intravaginal Device in people with Endometriosis and Pelvic Pain, run by Hyivy Health Inc 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 13 inclusion and 16 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: opening soon, as of the sponsor's last update on 17 Sep 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathew Leonardi, M.D. (905-521-2100 ext. 76252, leonam@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall self-reported pelvic pain (time frame: Baseline, 6-weeks, 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05643131, which also lists 7 linked publications.
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 17 Sep 2025.