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NCT05643131
Hyivy Device in Endometriosis
Conditions: Endometriosis, Pelvic Pain
Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 20
Sponsor: Hyivy Health Inc
Location: Canada
Summary
The objective of this study is to evaluate the effect of using the Hyivy device on overall self-reported pelvic pain in people with endometriosis
Eligibility Criteria
Inclusion Criteria:1.Age ≥ 18 at the time of enrollment2.Generally in good health (other than due to endometriosis), at physician's discretion3.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 baseline6.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 enrollment7.Agrees not to commence any new treatments (medical or physical therapies) for the 12-week intervention period8.Agrees not to undergo pelvic physiotherapy with a trained professional during the study9.Must have the ability to charge the investigational device10.Must be willing and able to insert intravaginal device11.Able to understand, comply and consent to protocol requirements and instructions12.Able to attend scheduled study visits and complete required investigationsExclusion Criteria:1.Chronic pelvic pain thought to be due to a condition other than endometriosis2.Diagnosis of premature ovarian insufficiency3.Has a condition rendering them unable to understand the nature, scope and possible consequences of the study, or evidence of an uncooperative attitude4.Any surgery in the past 3 months or anticipates having surgery during the study5.Allergy to Hyivy device's materials6.Active vaginal infection (e.g.
vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, STIs)7.Current use of antibiotics and a history of vulvovaginal candidiasis8.Pregnant or lactating9.Currently under the care of a pelvic floor physiotherapistPre-study washout:If potential study participants are pregnant, lactating, or initiating hormonal contraceptives, their eligibility to participate in the study can be re-evaluated after 3 months of hormonal contraceptive use prior to enrollment.If potential study participants have an active vaginal infection or are currently using antibiotics with a history of vulvovaginal candidiasis, their eligibility to participate in the study can be re-evaluated after treatment, and resolution of the infection.
Source: ClinicalTrials.gov (NCT05643131). StuddyBuddy aggregates publicly available trial information.