EndometriosisNCT05348005
Use of TENS Unit in the Management of Endometriosis Pain
A study testing Ovira Transcutaneous Electrical Nerve Stimulation Unit in people with Endometriosis and Pelvic Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Pelvic Pain
- What is being tested?
- Ovira Transcutaneous Electrical Nerve Stimulation Unit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to 16 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females ages 18-45 years at time of enrollment
- A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis
- Average monthly endometriosis pain flare
- Naïve TENS user
Who cannot join
- TENS device exclusion:
- Implantable devices (pacemaker, Interstim, etc.)
- Cardiac arrhythmia
- Open skin sores over areas of placement
- Pregnancy
- Nursing or trying to conceive at this time
Show all 10Show fewer
- Post-operative <12 weeks from abdominal or pelvic surgery
- Planned surgery or hormonal medication changes for duration of study if applicable
- Non-English speaking or inability to read and understand English
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain
The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.
Read the detailed description
The investigators propose to conduct a clinical study to evaluate the effectiveness of TENS units on the management of endometriosis flare-related pain. Subjects will participate in a 3-month "baseline" period (no TENS unit use for endometriosis flares) followed by a 3-month "treatment" period (TENS unit use for endometriosis flares).
Potential subjects will be pre-screened in the Penn State Minimally Invasive GYN (MIGS) Surgery Clinic for pathologically diagnosed endometriosis and from the Penn State MIGS endometriosis database. Potential subjects will then be called to evaluate the remainder of the inclusion and exclusion criteria. If fulfilled, potential subjects will follow up at the enrollment visit (Visit 1) where consent is reviewed and signed. The baseline QOL and FSFI REDCap surveys will be completed at this visit. Subjects will be set up to receive automated links to complete diary entries and surveys directly in REDCap.
Prior to initiating TENS unit use for endometriosis flare-related pain, subjects will record daily entries into RedCap during episodes of endometriosis flares for 3 months. Each entry will record their VAS pain score as well as medication intake and bleeding profile.
Subjects will then be mailed the TENS unit at the 3 months mark into the study. Subjects will then complete entries with TENS use at their discretion for the following 3 months and record TENS unit use duration, frequency, and side effects in addition to the documentation of pain, medication and bleeding. At the end of the study, subjects will complete a QOL and FSFI survey.
- Conditions
- Endometriosis, Pelvic Pain
- Being tested
- Ovira Transcutaneous Electrical Nerve Stimulation Unit
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovira Transcutaneous Electrical Nerve Stimulation UnitDevice
TENS units have a wide application from treatment of chronic back pain, chronic abdominal pain, cancer pain, perioperative pain, and labor pain.19-24 TENS units have been shown to be well-tolerated with minimal side effects and have been successful in reducing pain as well as pain medication use in patients with primary dysmenorrhea, which excludes pathology such as endometriosis. 11-18 Certain TENS units have also been FDA approved for the general indication of pelvic pain.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort for TENS | Other | Subjects will be observed for 3 months (no intervention) during which time they will track endometriosis flares, followed by a 3-month intervention (TENS unit use) during endometriosis flares with diary tracking. Receives: Device: Ovira Transcutaneous Electrical Nerve Stimulation Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Daily VAS Pain Score
Daily pain during endometriosis flares were recorded using a Visual Analog Scale (VAS), a horizontal line measuring pain from 0 (no pain) to 100 (worst pain). Per subject, an average pain score was calculated for the baseline period (no TENS use) and treatment period (TENS use). Change (treatment minus baseline) was estimated within the context of a repeated measures model; change in the positive direction represents worse outcome, change in the negative direction represents improvement.
Measured: Baseline period (months 1-3) and treatment period (months 4-6)
Secondary outcomes (2)
Change in Quality of Life Score From Baseline to End of Study Using the EHP30 Questionnaire
Change in quality of life from baseline to end of study using the Endometriosis Health Profile (EHP30) questionnaire. Scores range from 0 (best health status) to 100 (worst health status). Change (end of study minus baseline) was estimated within the context of a repeated measures model; change in the positive direction represents worse outcome, change in the negative direction represents improvement.
Measured: Baseline and end of study (6 months)
Change in Female Sexual Function Index (FSFI) Total Score From Baseline to End of Study
Change in FSFI validated survey scores from baseline to end of study among participants who are currently partnered. FSFI total score ranges from 2.0 (poor) to 36.0 (best). Change (end of study minus baseline) was estimated within the context of a repeated measures model; change in the positive direction represents improvement, change in the negative direction represents worse outcome.
Measured: Baseline and end of study (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start28 Jul 2022
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- clinical study to evaluate the effectiveness of TENS units on the management of endometriosis flare-related pain. Subjects will participate in a 3-month "baseline" period (no TENS unit use during endometriosis flares) followed by a 3-month "treatment" period (TENS unit use during endometriosis flares).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Riley, MD, Milton S. Hershey Medical Center
- Investigators
- Kristin W Riley, MD, Principal investigator, Penn State Health Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348005
- Sponsor's protocol ID
- STUDY00019024
- Status last verified
- Oct 2025
- First submitted
- 8 Dec 2021
- Last updated
- 4 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Burney RO, Giudice LC. Pathogenesis and pathophysiology of endometriosis. Fertil Steril. 2012 Sep;98(3):511-9. doi: 10.1016/j.fertnstert.2012.06.029. Epub 2012 Jul 20.
PubMed 22819144Bai HY, Bai HY, Yang ZQ. Effect of transcutaneous electrical nerve stimulation therapy for the treatment of primary dysmenorrheal. Medicine (Baltimore). 2017 Sep;96(36):e7959. doi: 10.1097/MD.0000000000007959.
PubMed 28885348Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
PubMed 15541453Lamvu G, Soliman AM, Manthena SR, Gordon K, Knight J, Taylor HS. Patterns of Prescription Opioid Use in Women With Endometriosis: Evaluating Prolonged Use, Daily Dose, and Concomitant Use With Benzodiazepines. Obstet Gynecol. 2019 Jun;133(6):1120-1130. doi: 10.1097/AOG.0000000000003267.
PubMed 31135725Coxon L, Horne AW, Vincent K. Pathophysiology of endometriosis-associated pain: A review of pelvic and central nervous system mechanisms. Best Pract Res Clin Obstet Gynaecol. 2018 Aug;51:53-67. doi: 10.1016/j.bpobgyn.2018.01.014. Epub 2018 Feb 15.
PubMed 29525437Rocha MG, e Silva JC, Ribeiro da Silva A, Candido Dos Reis FJ, Nogueira AA, Poli-Neto OB. TRPV1 expression on peritoneal endometriosis foci is associated with chronic pelvic pain. Reprod Sci. 2011 Jun;18(6):511-5. doi: 10.1177/1933719110391279. Epub 2010 Dec 15.
PubMed 21160085O'Hara R, Rowe H, Fisher J. Self-management in condition-specific health: a systematic review of the evidence among women diagnosed with endometriosis. BMC Womens Health. 2019 Jun 19;19(1):80. doi: 10.1186/s12905-019-0774-6.
PubMed 31216998Armour M, Sinclair J, Chalmers KJ, Smith CA. Self-management strategies amongst Australian women with endometriosis: a national online survey. BMC Complement Altern Med. 2019 Jan 15;19(1):17. doi: 10.1186/s12906-019-2431-x.
PubMed 30646891Goncalves AV, Makuch MY, Setubal MS, Barros NF, Bahamondes L. A Qualitative Study on the Practice of Yoga for Women with Pain-Associated Endometriosis. J Altern Complement Med. 2016 Dec;22(12):977-982. doi: 10.1089/acm.2016.0021. Epub 2016 Aug 23.
PubMed 27552065Huijs E, Nap A. The effects of nutrients on symptoms in women with endometriosis: a systematic review. Reprod Biomed Online. 2020 Aug;41(2):317-328. doi: 10.1016/j.rbmo.2020.04.014. Epub 2020 May 15.
PubMed 32600946Leonardi M, Horne AW, Vincent K, Sinclair J, Sherman KA, Ciccia D, Condous G, Johnson NP, Armour M. Self-management strategies to consider to combat endometriosis symptoms during the COVID-19 pandemic. Hum Reprod Open. 2020 Jun 1;2020(2):hoaa028. doi: 10.1093/hropen/hoaa028. eCollection 2020.
PubMed 32509977Schiotz HA, Jettestad M, Al-Heeti D. Treatment of dysmenorrhoea with a new TENS device (OVA). J Obstet Gynaecol. 2007 Oct;27(7):726-8. doi: 10.1080/01443610701612805.
PubMed 17999304Vance CG, Dailey DL, Rakel BA, Sluka KA. Using TENS for pain control: the state of the evidence. Pain Manag. 2014 May;4(3):197-209. doi: 10.2217/pmt.14.13.
PubMed 24953072Lauretti GR, Oliveira R, Parada F, Mattos AL. The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain. Neuromodulation. 2015 Aug;18(6):522-6; discussion 522-7. doi: 10.1111/ner.12269. Epub 2015 Feb 5.
PubMed 25655828Machado AFP, Perracini MR, Rampazo EP, Driusso P, Liebano RE. Effects of thermotherapy and transcutaneous electrical nerve stimulation on patients with primary dysmenorrhea: A randomized, placebo-controlled, double-blind clinical trial. Complement Ther Med. 2019 Dec;47:102188. doi: 10.1016/j.ctim.2019.08.022. Epub 2019 Aug 28.
PubMed 31779988
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain
- ClinicalTrials.gov ID
- NCT05348005
- Acronym / sponsor ID
- STUDY00019024
- Conditions
- Endometriosis, Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Posted 4 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.
Detailed description
The investigators propose to conduct a clinical study to evaluate the effectiveness of TENS units on the management of endometriosis flare-related pain. Subjects will participate in a 3-month "baseline" period (no TENS unit use for endometriosis flares) followed by a 3-month "treatment" period (TENS unit use for endometriosis flares).
Potential subjects will be pre-screened in the Penn State Minimally Invasive GYN (MIGS) Surgery Clinic for pathologically diagnosed endometriosis and from the Penn State MIGS endometriosis database. Potential subjects will then be called to evaluate the remainder of the inclusion and exclusion criteria. If fulfilled, potential subjects will follow up at the enrollment visit (Visit 1) where consent is reviewed and signed. The baseline QOL and FSFI REDCap surveys will be completed at this visit. Subjects will be set up to receive automated links to complete diary entries and surveys directly in REDCap.
Prior to initiating TENS unit use for endometriosis flare-related pain, subjects will record daily entries into RedCap during episodes of endometriosis flares for 3 months. Each entry will record their VAS pain score as well as medication intake and bleeding profile.
Subjects will then be mailed the TENS unit at the 3 months mark into the study. Subjects will then complete entries with TENS use at their discretion for the following 3 months and record TENS unit use duration, frequency, and side effects in addition to the documentation of pain, medication and bleeding. At the end of the study, subjects will complete a QOL and FSFI survey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- clinical study to evaluate the effectiveness of TENS units on the management of endometriosis flare-related pain. Subjects will participate in a 3-month "baseline" period (no TENS unit use during endometriosis flares) followed by a 3-month "treatment" period (TENS unit use during endometriosis flares).
| Arm | Type | Receives |
|---|---|---|
| Study Cohort for TENS | Other | Device: Ovira Transcutaneous Electrical Nerve Stimulation UnitSubjects will be observed for 3 months (no intervention) during which time they will track endometriosis flares, followed by a 3-month intervention (TENS unit use) during endometriosis flares with diary tracking. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females ages 18-45 years at time of enrollment
- A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis
- Average monthly endometriosis pain flare
- Naïve TENS user
Key exclusion criteria (10 listed)
- TENS device exclusion:
- Pregnancy
- Nursing or trying to conceive at this time
- Post-operative <12 weeks from abdominal or pelvic surgery
- Planned surgery or hormonal medication changes for duration of study if applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovira Transcutaneous Electrical Nerve Stimulation UnitTENS units have a wide application from treatment of chronic back pain, chronic abdominal pain, cancer pain, perioperative pain, and labor pain.19-24 TENS units have been shown to be well-tolerated with minimal side effects and have been successful in reducing pain as well as pain medication use in patients with primary dysmenorrhea, which excludes pathology such as endometriosis. 11-18 Certain TENS units have also been FDA approved for the general indication of pelvic pain. | Device | Study Cohort for TENS |
Primary outcome
Change in Average Daily VAS Pain Score
Time frame: Baseline period (months 1-3) and treatment period (months 4-6)
Daily pain during endometriosis flares were recorded using a Visual Analog Scale (VAS), a horizontal line measuring pain from 0 (no pain) to 100 (worst pain). Per subject, an average pain score was calculated for the baseline period (no TENS use) and treatment period (TENS use). Change (treatment minus baseline) was estimated within the context of a repeated measures model; change in the positive direction represents worse outcome, change in the negative direction represents improvement.
2 secondary outcomes
Change in Quality of Life Score From Baseline to End of Study Using the EHP30 Questionnaire
Time frame: Baseline and end of study (6 months)
Change in Female Sexual Function Index (FSFI) Total Score From Baseline to End of Study
Time frame: Baseline and end of study (6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22819144Burney RO, Giudice LC. Pathogenesis and pathophysiology of endometriosis. Fertil Steril. 2012 Sep;98(3):511-9. doi: 10.1016/j.fertnstert.2012.06.029. Epub 2012 Jul 20.
- Results publication: PubMed 28885348Bai HY, Bai HY, Yang ZQ. Effect of transcutaneous electrical nerve stimulation therapy for the treatment of primary dysmenorrheal. Medicine (Baltimore). 2017 Sep;96(36):e7959. doi: 10.1097/MD.0000000000007959.
- Results publication: PubMed 15541453Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
- Results publication: PubMed 31135725Lamvu G, Soliman AM, Manthena SR, Gordon K, Knight J, Taylor HS. Patterns of Prescription Opioid Use in Women With Endometriosis: Evaluating Prolonged Use, Daily Dose, and Concomitant Use With Benzodiazepines. Obstet Gynecol. 2019 Jun;133(6):1120-1130. doi: 10.1097/AOG.0000000000003267.
- Results publication: PubMed 29525437Coxon L, Horne AW, Vincent K. Pathophysiology of endometriosis-associated pain: A review of pelvic and central nervous system mechanisms. Best Pract Res Clin Obstet Gynaecol. 2018 Aug;51:53-67. doi: 10.1016/j.bpobgyn.2018.01.014. Epub 2018 Feb 15.
- Results publication: PubMed 21160085Rocha MG, e Silva JC, Ribeiro da Silva A, Candido Dos Reis FJ, Nogueira AA, Poli-Neto OB. TRPV1 expression on peritoneal endometriosis foci is associated with chronic pelvic pain. Reprod Sci. 2011 Jun;18(6):511-5. doi: 10.1177/1933719110391279. Epub 2010 Dec 15.
- Results publication: PubMed 31216998O'Hara R, Rowe H, Fisher J. Self-management in condition-specific health: a systematic review of the evidence among women diagnosed with endometriosis. BMC Womens Health. 2019 Jun 19;19(1):80. doi: 10.1186/s12905-019-0774-6.
- Results publication: PubMed 30646891Armour M, Sinclair J, Chalmers KJ, Smith CA. Self-management strategies amongst Australian women with endometriosis: a national online survey. BMC Complement Altern Med. 2019 Jan 15;19(1):17. doi: 10.1186/s12906-019-2431-x.
- Results publication: PubMed 27552065Goncalves AV, Makuch MY, Setubal MS, Barros NF, Bahamondes L. A Qualitative Study on the Practice of Yoga for Women with Pain-Associated Endometriosis. J Altern Complement Med. 2016 Dec;22(12):977-982. doi: 10.1089/acm.2016.0021. Epub 2016 Aug 23.
- Results publication: PubMed 32600946Huijs E, Nap A. The effects of nutrients on symptoms in women with endometriosis: a systematic review. Reprod Biomed Online. 2020 Aug;41(2):317-328. doi: 10.1016/j.rbmo.2020.04.014. Epub 2020 May 15.
- Results publication: PubMed 32509977Leonardi M, Horne AW, Vincent K, Sinclair J, Sherman KA, Ciccia D, Condous G, Johnson NP, Armour M. Self-management strategies to consider to combat endometriosis symptoms during the COVID-19 pandemic. Hum Reprod Open. 2020 Jun 1;2020(2):hoaa028. doi: 10.1093/hropen/hoaa028. eCollection 2020.
- Results publication: PubMed 17999304Schiotz HA, Jettestad M, Al-Heeti D. Treatment of dysmenorrhoea with a new TENS device (OVA). J Obstet Gynaecol. 2007 Oct;27(7):726-8. doi: 10.1080/01443610701612805.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin W Riley, MD principal investigator
Penn State Health Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovira Transcutaneous Electrical Nerve Stimulation Unit in people with Endometriosis and Pelvic Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Daily VAS Pain Score (time frame: Baseline period (months 1-3) and treatment period (months 4-6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05348005, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.