Sex DysfunctionNCT07626970
THE IMPACT OF WHATSAPP BASED EX-PLISSIT MODEL SEXUAL COUNSELING ON THE SEXUAL LIVES OF BREAST CANCER SURVIVORS
A study testing Sexual counseling group based on the EX-PLISSIT Model in people with Sex Dysfunction and Breast Cancer, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
Cancer is a significant health problem negatively impacting human health due to population growth, aging, and lifestyle changes known to cause cancer. According to World Health Organization sources, the number of newly diagnosed cancer patients, which was 19.3 million in 2020, is projected to reach 30.2 million in… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sex Dysfunction, Breast Cancer
- What is being tested?
- Sexual counseling group based on the EX-PLISSIT Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women diagnosed with breast cancer, stage 0, I, or II,
- Having undergone mastectomy, and at least 6 months having passed since the completion of radiotherapy and chemotherapy treatment,
- Aged 18-49, not pregnant, not breastfeeding, not menopausal,
- Women with sexual dysfunction (FSFI score 26.55 or lower), sexually active, married and living with their spouse.
Who cannot join
- Women with chronic, psychological, and physical illnesses,
- Those with alcohol and substance abuse,
- Those who have previously received education or counseling for sexual dysfunction,
- Women diagnosed with cancer other than breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF WHATSAPP BASED EX-PLISSIT MODEL SEXUAL COUNSELING ON SEXUAL FUNCTION AND SEXUAL DISTRESS IN BREAST CANCER SURVIVORS: A RANDOMIZED CONTROLLED STUDY
Cancer is a significant health problem negatively impacting human health due to population growth, aging, and lifestyle changes known to cause cancer. According to World Health Organization sources, the number of newly diagnosed cancer patients, which was 19.3 million in 2020, is projected to reach 30.2 million in 2040. Breast cancer, the most frequently diagnosed type of cancer in the female population worldwide, has an incidence of 47.8 per 100,000 globally and 47.7 per 100,000 in Turkey, according to 2020 GLOBOCAN data. Surgical treatment, chemotherapy, radiotherapy, and hormonal therapies used in the treatment of breast cancer, which has a high incidence worldwide and causes significant loss of workforce, have become important in altering the course of the disease. However, long-term treatments and related complications negatively affect the sexual functions of individuals. Women and men of reproductive age diagnosed with cancer; Even if they have survived cancer and benefited from curative treatments, they face sexual problems caused by the treatment. Individuals diagnosed with and treated for breast cancer experience difficulties in accessing counseling on issues related to their sexuality.Studies have shown that patients are hesitant to discuss sexual matters, need information about sexual problems during and after cancer treatment, but sexual counseling is not included in oncology care, and healthcare professionals focus more on medical issues. In this context, healthcare professionals can utilize many models for sexual counseling. The use of models in assessing sexual health guides healthcare professionals, facilitates the history-taking process, and helps in identifying sexual problems. The International Society for Research on Women's Sexual Health (ISSWSH) aims to establish a basic methodological strategy for identifying sexual problems in women and considering biological, psychological, sociocultural, and related factors that may cause sexual problems. The use of professional sexual assessment models by nurses in questioning and evaluating patient sexuality will be healthier and more effective. PLISSIT and EX-PLISSIT models are widely used by nurses working in primary care settings to address sexual health needs and concerns.
The PLISSIT model consists of four levels: P - Permission, LI - Limited Information, SS - Specific Suggestions, and IT - Intensive Therapy. As the intervention stages of the PLISSIT model progress, more comprehensive knowledge, training, and skills are required. The Ex-PLISSIT model has been developed as an extension of the PLISSIT model. Ex-PLISSIT is a more expanded version of the PLISSIT model, with the permission stage at its center. One cannot proceed to the next stage without obtaining permission.
- Conditions
- Sex Dysfunction, Breast Cancer
- Being tested
- Sexual counseling group based on the EX-PLISSIT Model
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual counseling group based on the EX-PLISSIT ModelBehavioural
Sexual counseling in the intervention group will be conducted according to the 4-stage EX-PLISSIT model. The EX-PLISSIT model will be implemented by the first author (SK), a specialist nurse who completed a PhD in obstetrics and gynecology nursing with a focus on sexuality. Furthermore, the first author (SK) attended a 120-hour Sexual Therapy Training Certificate Program prior to the study. This will be conducted both individually and in a group setting online. Appropriate training packages in the form of video clips, images, and audio recordings will be created by the research team and then shared via WhatsApp. The intervention consists of four counseling sessions, each lasting 30 to 60 minutes, once a week for four weeks. The control group will receive only routine care without any intervention.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| experimental group | Experimental | Sexual Counseling Based on the EX-PLISSIT Model Receives: Behavioral: Sexual counseling group based on the EX-PLISSIT Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the effect of sexual counseling on sexual function based on the BETTER model.
After sexual counseling based on the EX-PLISSIT model, the Female Sexual Function Index (FSFI) scale were administered to women in the experimental and control groups via face-to-face interviews. The administration time for each scale varied between 15 and 20 minutes.
Changes in the Female Sexual Function Index (FSFI) scale were measured two months after sexual counseling based on the BETTER model.
Female Sexual Function Index (FSFI) It was developed by Rosen et al. as a multidimensional scale comprising 19 items to evaluate female sexual function. The scale includes six subheadings, desire, arousal, lubrication, orgasm, satisfaction, and pain. Each title was scored between 0 or 1 and six. The lowest and highest scores are 2 and 36, respectively. Higher scores indicated better sexual function. The cut-off value of the scale was 26.55. A total FSFI score of ≤26.55, it indicates sexual dysfunction
Measured: one month
Secondary outcomes (1)
Measuring the effect of sexual counseling on sexual distress based on the BETTER model
After sexual counseling based on the EX-PLISSIT model, the Female Sexual Distress Scale-Revised (FSDS-R) scale were administered to women in the experimental and control groups via face-to-face interviews. The administration time for each scale varied between 15 and 20 minutes.
Changes in the Female Sexual Distress Scale-Revised (FSDS-R) scale were measured one months after sexual counseling based on the BETTER model.
Female Sexual Distress Scale-Revised (FSDS-R) Developed by Derogatis et al. (2008) to measure personal distress related to sexuality in women. The FSDS-R is a 13-item, 5-point Likert-type scale where items are scored on a 0-4 scale. The minimum score that can be obtained from the FSDS-R is "0", and the maximum score is "52". A higher score indicates a higher level of sexual distress. The cutoff point of the scale is 11.5. A score of 11.5 ≥ indicates the presence of sexual distress.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 May 2026
- Primary completion1 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Sex DysfunctionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Kırıcı, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626970
- Sponsor's protocol ID
- DECISION 02-2026/44
- Status last verified
- Oct 2026
- First submitted
- 30 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zahan, A., Sharma, N. K., Islam, M. N., Sen, S., & Bhowmik, K. R. (2025). Menopausal Symptoms and Coping Strategies among Women of 40-60 Years Age-Group: A Tertiary Care Hospital Experience from Bangladesh. Community Based Medical Journal, 14(1), 54-60.
Karadeniz, Z.C. (2019). Adaptation of the Female Genital Self-Image Scale and examination of its psychometric properties. Akdeniz University Institute of Health Sciences, Department of Nursing, Master's Thesis, Antalya.
Herbenick D, Reece M. Development and validation of the female genital self-image scale. J Sex Med. 2010 May;7(5):1822-30. doi: 10.1111/j.1743-6109.2010.01728.x. Epub 2010 Mar 3.
PubMed 20233278Zangeneh S, Savabi-Esfahani M, Taleghani F, Sharbafchi MR, Salehi M. Effectiveness of online sexual education based on the extended PLISSIT model on sexual function and sexual satisfaction in women undergoing breast cancer treatment. J Educ Health Promot. 2023 Sep 29;12:311. doi: 10.4103/jehp.jehp_1318_22. eCollection 2023.
PubMed 38023105Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
PubMed 10782451Derogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008 Feb;5(2):357-64. doi: 10.1111/j.1743-6109.2007.00672.x. Epub 2007 Nov 27.
PubMed 18042215Wettergren L, Kent EE, Mitchell SA, Zebrack B, Lynch CF, Rubenstein MB, Keegan THM, Wu XC, Parsons HM, Smith AW; AYA HOPE Study Collaborative Group. Cancer negatively impacts on sexual function in adolescents and young adults: The AYA HOPE study. Psychooncology. 2017 Oct;26(10):1632-1639. doi: 10.1002/pon.4181. Epub 2016 Jun 20.
PubMed 27240019Taylor B, Davis S. Using the extended PLISSIT model to address sexual healthcare needs. Nurs Stand. 2006 Nov 22-28;21(11):35-40. doi: 10.7748/ns2006.11.21.11.35.c6382.
PubMed 17165482Annon JS. The PLISSIT model: a proposed conceptual. General procedures: handbook of behavior therapy with sexual problems. 2013; 1:70.
Yörük F, Karacam Z. The effectiveness of the PLISSIT model in solving postpartum sexual problems experienced by women. Athens J Health. 2016;3(3):235-7.
Yu Y, Sherman KA. Communication avoidance, coping and psychological distress of women with breast cancer. J Behav Med. 2015 Jun;38(3):565-77. doi: 10.1007/s10865-015-9636-3. Epub 2015 Mar 25.
PubMed 25804374Ghaemi SZ, Keshavarz Z, Tahmasebi S, Akrami M, Heydari ST. Conflicts women with breast cancer face with: A qualitative study. J Family Med Prim Care. 2019 Jan;8(1):27-36. doi: 10.4103/jfmpc.jfmpc_272_18.
PubMed 30911477Turkish Ministry of Health, Public Health Institute of Turkey, Turkish Cancer Statistics, Ankara, 2021 [cited 2021 29.09.2021].https://hsgm.saglik.gov.tr/depo/birimler/kanser-db/istatistik/Turkiye_Kanser_Istatistikleri_2017.pdf
Kocamaz D, Tuncer A, Yamak D, Sever O, Yıldırım M. Cancer and oncological rehabilitation. Journal of Zeugma Health Research Journal. 2019; 1:24-9.
WHO. World Health Organization Cancer, 2020 [cited 2022 15.01.2022]. https://gco.iarc.fr/tomorrow/en/dataviz/ isotype?types=0&single_unit=500000
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF WHATSAPP BASED EX-PLISSIT MODEL SEXUAL COUNSELING ON SEXUAL FUNCTION AND SEXUAL DISTRESS IN BREAST CANCER SURVIVORS: A RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT07626970
- Acronym / sponsor ID
- DECISION 02-2026/44
- Conditions
- Sex Dysfunction, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer is a significant health problem negatively impacting human health due to population growth, aging, and lifestyle changes known to cause cancer. According to World Health Organization sources, the number of newly diagnosed cancer patients, which was 19.3 million in 2020, is projected to reach 30.2 million in 2040. Breast cancer, the most frequently diagnosed type of cancer in the female population worldwide, has an incidence of 47.8 per 100,000 globally and 47.7 per 100,000 in Turkey, according to 2020 GLOBOCAN data. Surgical treatment, chemotherapy, radiotherapy, and hormonal therapies used in the treatment of breast cancer, which has a high incidence worldwide and causes significant loss of workforce, have become important in altering the course of the disease. However, long-term treatments and related complications negatively affect the sexual functions of individuals. Women and men of reproductive age diagnosed with cancer; Even if they have survived cancer and benefited from curative treatments, they face sexual problems caused by the treatment. Individuals diagnosed with and treated for breast cancer experience difficulties in accessing counseling on issues related to their sexuality.Studies have shown that patients are hesitant to discuss sexual matters, need information about sexual problems during and after cancer treatment, but sexual counseling is not included in oncology care, and healthcare professionals focus more on medical issues. In this context, healthcare professionals can utilize many models for sexual counseling. The use of models in assessing sexual health guides healthcare professionals, facilitates the history-taking process, and helps in identifying sexual problems. The International Society for Research on Women's Sexual Health (ISSWSH) aims to establish a basic methodological strategy for identifying sexual problems in women and considering biological, psychological, sociocultural, and related factors that may cause sexual problems. The use of professional sexual assessment models by nurses in questioning and evaluating patient sexuality will be healthier and more effective. PLISSIT and EX-PLISSIT models are widely used by nurses working in primary care settings to address sexual health needs and concerns.
The PLISSIT model consists of four levels: P - Permission, LI - Limited Information, SS - Specific Suggestions, and IT - Intensive Therapy. As the intervention stages of the PLISSIT model progress, more comprehensive knowledge, training, and skills are required. The Ex-PLISSIT model has been developed as an extension of the PLISSIT model. Ex-PLISSIT is a more expanded version of the PLISSIT model, with the permission stage at its center. One cannot proceed to the next stage without obtaining permission.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| experimental group | Experimental | Behavioral: Sexual counseling group based on the EX-PLISSIT ModelSexual Counseling Based on the EX-PLISSIT Model |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women diagnosed with breast cancer, stage 0, I, or II,
- Having undergone mastectomy, and at least 6 months having passed since the completion of radiotherapy and chemotherapy treatment,
- Aged 18-49, not pregnant, not breastfeeding, not menopausal,
- Women with sexual dysfunction (FSFI score 26.55 or lower), sexually active, married and living with their spouse.
Key exclusion criteria (4 listed)
- Women with chronic, psychological, and physical illnesses,
- Those with alcohol and substance abuse,
- Those who have previously received education or counseling for sexual dysfunction,
- Women diagnosed with cancer other than breast cancer
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 |
|---|---|---|
| Sexual counseling group based on the EX-PLISSIT ModelSexual counseling in the intervention group will be conducted according to the 4-stage EX-PLISSIT model. The EX-PLISSIT model will be implemented by the first author (SK), a specialist nurse who completed a PhD in obstetrics and gynecology nursing with a focus on sexuality. Furthermore, the first author (SK) attended a 120-hour Sexual Therapy Training Certificate Program prior to the study. This will be conducted both individually and in a group setting online. Appropriate training packages in the form of video clips, images, and audio recordings will be created by the research team and then shared via WhatsApp. The intervention consists of four counseling sessions, each lasting 30 to 60 minutes, once a week for four weeks. The control group will receive only routine care without any intervention. | Behavioural | experimental group |
Primary outcome
Measuring the effect of sexual counseling on sexual function based on the BETTER model.
Time frame: one month
After sexual counseling based on the EX-PLISSIT model, the Female Sexual Function Index (FSFI) scale were administered to women in the experimental and control groups via face-to-face interviews. The administration time for each scale varied between 15 and 20 minutes. Changes in the Female Sexual Function Index (FSFI) scale were measured two months after sexual counseling based on the BETTER model. Female Sexual Function Index (FSFI) It was developed by Rosen et al. as a multidimensional scale comprising 19 items to evaluate female sexual function. The scale includes six subheadings, desire, arousal, lubrication, orgasm, satisfaction, and pain. Each title was scored between 0 or 1 and six. The lowest and highest scores are 2 and 36, respectively. Higher scores indicated better sexual function. The cut-off value of the scale was 26.55. A total FSFI score of ≤26.55, it indicates sexual dysfunction
1 secondary outcome
Measuring the effect of sexual counseling on sexual distress based on the BETTER model
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- BackgroundZahan, A., Sharma, N. K., Islam, M. N., Sen, S., & Bhowmik, K. R. (2025). Menopausal Symptoms and Coping Strategies among Women of 40-60 Years Age-Group: A Tertiary Care Hospital Experience from Bangladesh. Community Based Medical Journal, 14(1), 54-60.
- BackgroundKaradeniz, Z.C. (2019). Adaptation of the Female Genital Self-Image Scale and examination of its psychometric properties. Akdeniz University Institute of Health Sciences, Department of Nursing, Master's Thesis, Antalya.
- Background: PubMed 20233278Herbenick D, Reece M. Development and validation of the female genital self-image scale. J Sex Med. 2010 May;7(5):1822-30. doi: 10.1111/j.1743-6109.2010.01728.x. Epub 2010 Mar 3.
- Background: PubMed 38023105Zangeneh S, Savabi-Esfahani M, Taleghani F, Sharbafchi MR, Salehi M. Effectiveness of online sexual education based on the extended PLISSIT model on sexual function and sexual satisfaction in women undergoing breast cancer treatment. J Educ Health Promot. 2023 Sep 29;12:311. doi: 10.4103/jehp.jehp_1318_22. eCollection 2023.
- Background: PubMed 10782451Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
- Background: PubMed 18042215Derogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008 Feb;5(2):357-64. doi: 10.1111/j.1743-6109.2007.00672.x. Epub 2007 Nov 27.
- Background: PubMed 27240019Wettergren L, Kent EE, Mitchell SA, Zebrack B, Lynch CF, Rubenstein MB, Keegan THM, Wu XC, Parsons HM, Smith AW; AYA HOPE Study Collaborative Group. Cancer negatively impacts on sexual function in adolescents and young adults: The AYA HOPE study. Psychooncology. 2017 Oct;26(10):1632-1639. doi: 10.1002/pon.4181. Epub 2016 Jun 20.
- Background: PubMed 17165482Taylor B, Davis S. Using the extended PLISSIT model to address sexual healthcare needs. Nurs Stand. 2006 Nov 22-28;21(11):35-40. doi: 10.7748/ns2006.11.21.11.35.c6382.
- BackgroundAnnon JS. The PLISSIT model: a proposed conceptual. General procedures: handbook of behavior therapy with sexual problems. 2013; 1:70.
- BackgroundYörük F, Karacam Z. The effectiveness of the PLISSIT model in solving postpartum sexual problems experienced by women. Athens J Health. 2016;3(3):235-7.
- Background: PubMed 25804374Yu Y, Sherman KA. Communication avoidance, coping and psychological distress of women with breast cancer. J Behav Med. 2015 Jun;38(3):565-77. doi: 10.1007/s10865-015-9636-3. Epub 2015 Mar 25.
- Background: PubMed 30911477Ghaemi SZ, Keshavarz Z, Tahmasebi S, Akrami M, Heydari ST. Conflicts women with breast cancer face with: A qualitative study. J Family Med Prim Care. 2019 Jan;8(1):27-36. doi: 10.4103/jfmpc.jfmpc_272_18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual counseling group based on the EX-PLISSIT Model in people with Sex Dysfunction and Breast Cancer, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
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 4 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 20 Oct 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measuring the effect of sexual counseling on sexual function based on the BETTER model. (time frame: one month). 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 NCT07626970, which also lists 16 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 20 Oct 2026.