NCT07393295Recruiting
Efficacy and Tolerability of TENS in Endometriosis-related Pain
Evaluation of the Efficacy and Tolerability of a Transcutaneous Electrical Nerve Stimulation (TENS) Device for the Management of Endometriosis-associated Pain
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
ELECTRE is a single-center, randomized, prospective, longitudinal, controlled, two-arm, single-blind study lasting 4 weeks (P1 investigation phase) after a 4-week run-in period. The study is followed by a 4-week extension phase (P2) in which all participants will be treated with active TENS. Randomization will be balanced according to a 1:1 ratio.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 23 Jan 2026
- Start date
- 15 Mar 2026
- Primary completion date
- 15 Jun 2027
- Lead sponsor
- Monath Electronic
- Diseases
- Endometriosis
- NCT number
- NCT07393295
What you commit to
- Study type: Interventional
- Planned participants: 92
- From 15 Mar 2026 to the primary completion date, 15 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcoholism or drug addiction
- Gynecological and/or endometriosis surgery planned within the next 3 months
Other illness
- Skin allergy to the gel or electrodes
- Epilepsy
- Current thrombophlebitis or arterial thrombosis
- Cancer or malignant disease with an expected survival of \< 12 months
- Untreated severe psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition
- History of endometriosis surgery within the last 6 months
Other
- Pregnant or breastfeeding women
- Menopausal women
- Patients who, in the investigator's opinion, have experienced an acute worsening of endometriosis symptoms in the last 28 days
- Patients with altered sensitivity in the area where the device is applied (hypoesthesia)
- Dermatological problem in the stimulation area
- Patients with an implanted pacemaker or active implanted medical device.
- Fibromyalgia
- Women who have already tried TENS
- Patients unable to understand and use the English language to communicate fluently
- Patients with cognitive impairments
- Participation in another intervention study that may impact the results of the current study
- Patient using \> 90 morphine equivalents/day (at least once in the last 28 days)
- Patient who has undergone a hysterectomy or bilateral oophorectomy
- Patient under legal protection (guardianship or conservatorship) or patient deprived of liberty
Who the study is looking for
- Women aged ≥ 18 years
- Endometriosis and/or adenomyosis diagnosed by imaging and/or histology
- Undergoing continuous, stable, and functional hormone treatment (with no menstruation) for at least 2 months
- No change in hormone treatment planned for the duration of the study
- Chronic pelvic pain for more than 6 months
- Pelvic pain at least equal to 2 out of 3 (on the intensity scale: "0 - None," "1 - Mild," "2 - Moderate," "3 - Severe")
- Agreeing to participate in the study
- Agrees to limit pain relief treatment during the study to level I painkillers paracetamol and Acupan® (nefopam), and the NSAID Antadys® (flurbiprofen)
- Has a computer, tablet, or cell phone with an internet connection
- Is affiliated with a social security system or is a beneficiary of such a system
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IFEM Endo, Clinique Tivoli-Ducos Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.