Hyivy Device as Non-hormonal Therapy in Endometriosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHyivy Health Inc
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Hyivy Intravaginal Device
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Hyivy Health Inc
Lead sponsor
McMaster University
Collaborator
Source ClinicalTrials.gov