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Endocare for Pelvic-perineal Pain Related to Endometriosis Used at Home

NCT05172492 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-01-04

No results posted yet for this study

Summary

Women with endometriosis experience recurrent pelvic-perineal pain impairing the quality of life, among other things. Endometriosis-related pain negatively impacts the sexual, family and work life.

Apart from the usual painkillers, the doctor's current therapeutic arsenal is limited to hormonal contraceptives and surgery. As endometriosis-related treatments do not currently address all of the patients' problems, developing a new, effective, non-pharmaceutical treatment would make it possible to relieve the pain of these women.

Endocare treatment consists of visual and auditory therapeutic procedures for pelvic-perineal pain in patients with endometriosis.

Moreover, as Endocare is not a pharmacological molecule but a digital therapy, it would not increase the consumption of pharmacological agents. An analgesic effect of Endocare lasting several hours on chronic pelvic-perineal pain associated with endometriosis is expected.

The effects of the treatment will be compare to a digital control also integrated in a virtual reality headset identical to the one distributing Endocare allowing to maintain the blindness to the patients and the investigator on the treatment received.

Conditions

Interventions

DEVICE

Endocare

Endocare will be administred through a virtual reality headseat used one to twice a day.

DEVICE

Digital control

Digital control will be administred through a virtual reality headseat used one to twice a day.

Sponsors & Collaborators

  • Biotrial

    collaborator INDUSTRY

  • Lucine

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05172492 on ClinicalTrials.gov