NCT05643131

Hyivy Device as Non-hormonal Therapy in Endometriosis

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hyivy Health Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-12-08
• Last updated: 2025-09-17

Locations

1 site across 1 country: Canada