Hyivy Device as Non-hormonal Therapy in Endometriosis

NCT05643131 | Not Yet Recruiting DMC

• 1 other identifier: HYV-001-C23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 endometriosis-associated chronic pelvic pain following the use of the Hyivy intravaginal device.

Conditions

Endometriosis; Pelvic Pain

Keywords

Endometriosis; Pelvic Pain; Dilator

Outcome Measures

Primary Outcomes (1)

• Overall self-reported pelvic pain

  Overall pelvic pain will be evaluated using a digital visual analog scale (VAS)

  Baseline, 6-weeks, 12-weeks

Secondary Outcomes (7)

• Site-specific tenderness and pelvic floor muscle pain

  Baseline, 6-weeks, 12-weeks

• Quality of Life (EHP-30)

  Baseline, 6-weeks, 12-weeks

• Sexual Function (FSFI)

  Baseline, 6-weeks, 12-weeks

• Safety and tolerability of the Hyivy device

  Up to 12-weeks

• Adherence to study protocol

  6-weeks, 12-weeks

Other Outcomes (4)

• Autonomic function

  Baseline, 6-weeks, 12-weeks

• Peripheral gene expression

  Baseline, 6-weeks, 12-weeks

• Emergency room (ER) visits

  Baseline, 6-weeks, 12-weeks

Study Arms (1)

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.

Device: Hyivy Intravaginal Device

Interventions

Hyivy Intravaginal Device 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.

Hyivy Intravaginal Device

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 at the time of enrollment
• Generally in good health (other than due to endometriosis), at physician's discretion
• Diagnosed with endometriosis (clinical, radiologic, or surgical)
• Diagnosed with chronic pelvic pain (self-reported pain in pelvic area lasting \>3 months)
• VAS for overall pelvic pain ≥ 4 at screening and baseline
• 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
• 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
• Agrees not to undergo pelvic physiotherapy with a trained professional during the study
• Agrees to avoid taking non-steroidal anti-inflammatory drugs (e.g., ibuprofen) for 72 hours before Visits 1, 2, and 3
• Must have the ability to charge the investigational device
• Must be willing and able to insert intravaginal device
• Able to understand, comply and consent to protocol requirements and instructions
• Able to attend scheduled study visits and complete required investigations

You may not qualify if:

• Chronic pelvic pain thought to be due to a condition other than endometriosis
• Diagnosis of premature ovarian insufficiency
• 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)
• Any surgery in the past 3 months or anticipates having surgery during the study
• Allergy to Hyivy device's materials
• Active vaginal infection (e.g. vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, STIs) or infection in the pelvic area
• Current use of antibiotics and a history of vulvovaginal candidiasis
• Pregnant or lactating
• Currently under the care of a pelvic floor physiotherapist
• Have open wounds, cuts, or open sores present in vaginal or pelvic area
• Severe atrophic vaginitis or very dry, itchy, or sore vagina/vaginal area, at the discretion of the primary investigator(s)
• Hypoesthesia or loss in sensation of the pelvic floor
• Total and/or partial prolapse of the uterus and/or vagina
• Symptoms of severe urinary retention, severe extra-urethral incontinence or overflow incontinence
• Unable to position the device according to directions for use

Sponsors & Collaborators

• Hyivy Health Inc: lead
• McMaster University: collaborator

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (7)

• 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.

  PMID: 32001176 BACKGROUND

• Kong 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.

  PMID: 24701237 BACKGROUND

• Vercellini 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.

  PMID: 24366116 BACKGROUND

• Becker 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.

  PMID: 28668150 BACKGROUND

• As-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.

  PMID: 30790565 BACKGROUND

• Duffy 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.

  PMID: 32227676 BACKGROUND

• Nnoaham 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.

  PMID: 21718982 BACKGROUND

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mathew Leonardi, M.D.

  McMaster University Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathew Leonardi, M.D.

CONTACT

905-521-2100; leonam@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective observational pre/post repeated-measures pilot intervention study

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: December 8, 2022
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)