Hyivy Device as Non-hormonal Therapy in Endometriosis

Sponsor
Hyivy Health Inc
Study ID
NCT05643131
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Dec 8, 2022
Start date
Oct 31, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall self-reported pelvic pain [ Time Frame: Baseline, 6-weeks, 12-weeks ]

Central Contacts

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