Vaginal DrynessRF-VaginaleNCT06900374
Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients
A study testing GynWave-360 and Local hydratation in people with Vaginal Dryness and Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial summary
This Phase III, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. The study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Vaginal Dryness, Breast Cancer, Vulvovaginal Atrophy
- What is being tested?
- GynWave-360 and Local hydratation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 40 years
- Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3
- Patient undergoing adjuvant treatment for breast cancer
- Patient treated with aromatase inhibitors +/- LHRH agonist for at least 3 months with a planned remaining duration of at least 12 months
- Patient affiliated to a social security organization
- Patient having signed the informed consent for the present study
Who cannot join
- Contraindications related to the radiofrequency technique:
- Ongoing urinary tract infection
- Pacemaker
- IUD intrauterine device
- Pregnancy
- Mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc.
Show all 10Show fewer
- Neurodegenerative disease with perineal involvement
- Current or recent treatment (within the last 12 months) with other physical methods: vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection or lipo-modeling.
- Pregnant or breast-feeding women
- Patients under guardianship or trusteeship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Oscar Lambret
Lille, 59020
Julie JD DEMETZ, MD, +33320295935, j-demetz@o-lambret.fr
About this study
Official title: RF-Vaginale : Randomised Phase III Trial Evaluating the Efficacy and Safety of Vaginal Radiofrequency in the Management of Vulvovaginal Atrophy and Dryness in Patients Treated for Breast Cancer
This Phase III, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. The study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal therapy with aromatase inhibitors, with or without LHRH agonists, for breast cancer.
Patients will be randomly assigned to one of two parallel treatment groups until the six-month assessment:
Read more
The first group will receive the reference treatment, which consists of local hydration using a hyaluronic acid-based treatment applied three times a week. Additionally, investigators may incorporate supportive measures at their discretion, such as physiotherapy or vaginal dilators.
The second group will receive the same reference treatment combined with vaginal radiofrequency therapy. This intervention consists of three sessions, each spaced 4 to 6 weeks apart.
Read the detailed description
This study aims to see if vaginal radiofrequency therapy can help reduce vaginal dryness in women receiving hormone therapy for breast cancer.
The participants are divided into two groups:
One group will use a non-hormonal vaginal moisturizer (hyaluronic acid) three times a week. If needed, they can also use other supportive treatments like physiotherapy or vaginal dilators.
The other group will receive the same moisturizer treatment but will also have three sessions of vaginal radiofrequency therapy, with each session spaced 4 to 6 weeks apart.
After six months, researchers will compare the two groups to see if vaginal radiofrequency provides additional benefits in relieving vaginal dryness.
- Conditions
- Vaginal Dryness, Breast Cancer, Vulvovaginal Atrophy
- Being tested
- GynWave-360, Local hydratation
- Keywords
- Vaginal dryness, vaginal atrophy, vaginal radiofrequency, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GynWave-360Device
For patients randomized to the experimental group:
3 sessions of 20 minutes each, spaced 4 to 6 weeks apart (M0, M1, M2) ideally, with +/- 1 maintenance session between 8 and 12 months after the first session (M8-12).
Local hydratationOther
Reference treatment combining local hydration (hyaluronic acid-based treatment, 3 times a week), with the possibility of using associated measures at the investigator's discretion (physiotherapy, vaginal dilators, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Vaginal radiofrequency treatment | Experimental | The evaluator will be blinded to the intervention (different investigator for vaginal radiofrequency sessions and clinical evaluation consultationsup to 6 months, M0, M3 and M6).
The blinding will be lifted after the 6-month evaluation, with the possibility of radiofrequency treatment for patients in the control group who are not sufficiently relieved. Receives: Device: GynWave-360; Other: Local hydratation |
| Reference treatment | Active comparator | Local hydration: hyaluronic acid-based treatment, 3 applications per week Possibility of resorting to associated measures chosen by the investigator (physical therapy, vaginal dilators, etc.), excluding physical treatments (vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection, or lipomodelling). Receives: Other: Local hydratation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical scale for vaginal dryness according to patient
Patient-rated 0-10 Numerical Rating Scale for vaginal dryness, minimum value =0; maximum value = 10; where 0 = No dryness and 10 = Maximum possible dryness.
Measured: The main analysis will focus on assessment at 6 months (M6). This endpoint will also be assessed at baseline (M0), 3 and 12 months (M3, M12).
Secondary outcomes (7)
Patient-Rated 0-10 numerical scale for dyspareunia
Patient-rated 0-10 numerical rating scale for dyspareunia, minimum value = 0; maximum value = 10; where 0 = No pain during intercourse and 10 = Maximum possible pain
Measured: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS) : vaginal elasticity score
Vaginal elasticity is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:
- = None
- = Poor
- = Fair
- = Good
- = Excellent
Higher scores indicate better vaginal elasticity.
Measured: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS) : vaginal fluid volume score
Vaginal fluid volume is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:
- = None
- = Scar amount (vault not entirely covered)
- = Superficial amount (vault entirely covered)
- = Moderate amount
- = Normal amount Higher scores indicate greater fluid volume, which reflects better vaginal hydration.
Measured: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS) : vaginal pH measurement
Vaginal pH is measured using a pH test strip applied to the vaginal mucosa by a physician observer. The pH is categorized as follows:
- = ≥6.1
- = 5.6-6.0
- = 5.1-5.5
- = 4.7-5.0
- = ≤4.6 Lower values indicate a healthier vaginal environment.
Measured: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS): vaginal epithelial integrity score
Epithelial integrity is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:
- = Petechiae noted before contact
- = Bleeds with light contact
- = Bleeds with scraping
- = Not friable (thin epithelium)
- = Normal Higher scores indicate better vaginal epithelial integrity.
Measured: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS): vaginal moisture score
Vaginal moisture is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:
- = None (surface inflamed)
- = None (surface non-inflamed)
- = Minimal
- = Moderate
- = Normal Higher scores indicate better vaginal moisture levels.
Measured: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Side effects of radiofrequency treatment
Type of side effects : sensation of heat, redness, erythema, hypersensitivity, dyspareunia, other.
Time of onset : during the session, immediately after, or more than 24 hours after the session.
Intensity : graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0), with scores ranging from Grade 1 (mild) to Grade 5 (death). Higher scores indicate greater severity of adverse effects.
Consequences for the treatment: need to interrupt the session, reduce the radiofrequency temperature, etc.
Measured: through study completion: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start12 Jun 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Vaginal DrynessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The evaluator will be blinded to the intervention (different investigator for vaginal radiofrequency sessions and clinical evaluation consultations) Blinding will be lifted after the 6-month evaluation, with the possibility of radiofrequency treatment for control group patients who are insufficiently relieved
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- MATMATECH
- Responsible party
- Sponsor
- Investigators
- Julie DEMETZ, MD, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900374
- Sponsor's protocol ID
- RF-Vaginale-2401
- Other IDs
- API-23-18, 2024-A01126-41
- Acronym
- RF-Vaginale
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faubion SS, Sood R, Kapoor E. Genitourinary Syndrome of Menopause: Management Strategies for the Clinician. Mayo Clin Proc. 2017 Dec;92(12):1842-1849. doi: 10.1016/j.mayocp.2017.08.019.
PubMed 29202940Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014 Oct;21(10):1063-8. doi: 10.1097/GME.0000000000000329.
PubMed 25160739Moral E, Delgado JL, Carmona F, Caballero B, Guillan C, Gonzalez PM, Suarez-Almarza J, Velasco-Ortega S, Nieto C; as the writing group of the GENISSE study. Genitourinary syndrome of menopause. Prevalence and quality of life in Spanish postmenopausal women. The GENISSE study. Climacteric. 2018 Apr;21(2):167-173. doi: 10.1080/13697137.2017.1421921. Epub 2018 Feb 7.
PubMed 29411644Simon JA, Davis SR, Althof SE, Chedraui P, Clayton AH, Kingsberg SA, Nappi RE, Parish SJ, Wolfman W. Sexual well-being after menopause: An International Menopause Society White Paper. Climacteric. 2018 Oct;21(5):415-427. doi: 10.1080/13697137.2018.1482647. Epub 2018 Jul 10.
PubMed 29987939Nappi RE, Cucinella L, Martella S, Rossi M, Tiranini L, Martini E. Female sexual dysfunction (FSD): Prevalence and impact on quality of life (QoL). Maturitas. 2016 Dec;94:87-91. doi: 10.1016/j.maturitas.2016.09.013. Epub 2016 Sep 28.
PubMed 27823751Kaur N, Gupta A, Sharma AK, Jain A. Survivorship issues as determinants of quality of life after breast cancer treatment: Report from a limited resource setting. Breast. 2018 Oct;41:120-126. doi: 10.1016/j.breast.2018.07.003. Epub 2018 Jul 11.
PubMed 30029054Oyarzun MFG, Castelo-Branco C. Local hormone therapy for genitourinary syndrome of menopause in breast cancer patients: is it safe? Gynecol Endocrinol. 2017 Jun;33(6):418-420. doi: 10.1080/09513590.2017.1290076. Epub 2017 Feb 21.
PubMed 28277141Lubian Lopez DM. Management of genitourinary syndrome of menopause in breast cancer survivors: An update. World J Clin Oncol. 2022 Feb 24;13(2):71-100. doi: 10.5306/wjco.v13.i2.71.
PubMed 35316932Sulaica E, Han T, Wang W, Bhat R, Trivedi MV, Niravath P. Vaginal estrogen products in hormone receptor-positive breast cancer patients on aromatase inhibitor therapy. Breast Cancer Res Treat. 2016 Jun;157(2):203-210. doi: 10.1007/s10549-016-3827-7. Epub 2016 May 13.
PubMed 27178335Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003 Nov 6;349(19):1793-802. doi: 10.1056/NEJMoa032312. Epub 2003 Oct 9.
PubMed 14551341Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Pater JL. Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst. 2005 Sep 7;97(17):1262-71. doi: 10.1093/jnci/dji250.
PubMed 16145047Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. N Engl J Med. 2016 Jul 21;375(3):209-19. doi: 10.1056/NEJMoa1604700. Epub 2016 Jun 5.
PubMed 27264120Hocke C, Diaz M, Bernard V, Frantz S, Lambert M, Mathieu C, Grellety-Cherbero M. [Genitourinary menopause syndrome. Postmenopausal women management: CNGOF and GEMVi clinical practice guidelines]. Gynecol Obstet Fertil Senol. 2021 May;49(5):394-413. doi: 10.1016/j.gofs.2021.03.025. Epub 2021 Mar 20. French.
PubMed 33757926Faubion SS, Larkin LC, Stuenkel CA, Bachmann GA, Chism LA, Kagan R, Kaunitz AM, Krychman ML, Parish SJ, Partridge AH, Pinkerton JV, Rowen TS, Shapiro M, Simon JA, Goldfarb SB, Kingsberg SA. Management of genitourinary syndrome of menopause in women with or at high risk for breast cancer: consensus recommendations from The North American Menopause Society and The International Society for the Study of Women's Sexual Health. Menopause. 2018 Jun;25(6):596-608. doi: 10.1097/GME.0000000000001121.
PubMed 29762200Loprinzi CL, Abu-Ghazaleh S, Sloan JA, vanHaelst-Pisani C, Hammer AM, Rowland KM Jr, Law M, Windschitl HE, Kaur JS, Ellison N. Phase III randomized double-blind study to evaluate the efficacy of a polycarbophil-based vaginal moisturizer in women with breast cancer. J Clin Oncol. 1997 Mar;15(3):969-73. doi: 10.1200/JCO.1997.15.3.969.
PubMed 9060535
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RF-Vaginale : Randomised Phase III Trial Evaluating the Efficacy and Safety of Vaginal Radiofrequency in the Management of Vulvovaginal Atrophy and Dryness in Patients Treated for Breast Cancer
- ClinicalTrials.gov ID
- NCT06900374
- Acronym / sponsor ID
- RF-Vaginale / RF-Vaginale-2401
- Conditions
- Vaginal Dryness, Breast Cancer, Vulvovaginal Atrophy
- Keywords
- Vaginal dryness, vaginal atrophy, vaginal radiofrequency, breast cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- MATMATECH
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 28 Mar 2025 (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.
This Phase III, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. The study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal therapy with aromatase inhibitors, with or without LHRH agonists, for breast cancer.
Patients will be randomly assigned to one of two parallel treatment groups until the six-month assessment:
The first group will receive the reference treatment, which consists of local hydration using a hyaluronic acid-based treatment applied three times a week. Additionally, investigators may incorporate supportive measures at their discretion, such as physiotherapy or vaginal dilators.
The second group will receive the same reference treatment combined with vaginal radiofrequency therapy. This intervention consists of three sessions, each spaced 4 to 6 weeks apart.
Detailed description
This study aims to see if vaginal radiofrequency therapy can help reduce vaginal dryness in women receiving hormone therapy for breast cancer.
The participants are divided into two groups:
One group will use a non-hormonal vaginal moisturizer (hyaluronic acid) three times a week. If needed, they can also use other supportive treatments like physiotherapy or vaginal dilators.
The other group will receive the same moisturizer treatment but will also have three sessions of vaginal radiofrequency therapy, with each session spaced 4 to 6 weeks apart.
After six months, researchers will compare the two groups to see if vaginal radiofrequency provides additional benefits in relieving vaginal dryness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The evaluator will be blinded to the intervention (different investigator for vaginal radiofrequency sessions and clinical evaluation consultations) Blinding will be lifted after the 6-month evaluation, with the possibility of radiofrequency treatment for control group patients who are insufficiently relieved
| Arm | Type | Receives |
|---|---|---|
| Vaginal radiofrequency treatment | Experimental | Device: GynWave-360, Other: Local hydratationThe evaluator will be blinded to the intervention (different investigator for vaginal radiofrequency sessions and clinical evaluation consultationsup to 6 months, M0, M3 and M6). The blinding will be lifted after the 6-month evaluation, with the possibility of radiofrequency treatment for patients in the control group who are not sufficiently relieved. |
| Reference treatment | Active comparator | Other: Local hydratationLocal hydration: hyaluronic acid-based treatment, 3 applications per week Possibility of resorting to associated measures chosen by the investigator (physical therapy, vaginal dilators, etc.), excluding physical treatments (vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection, or lipomodelling). |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient over 40 years
- Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3
- Patient undergoing adjuvant treatment for breast cancer
- Patient treated with aromatase inhibitors +/- LHRH agonist for at least 3 months with a planned remaining duration of at least 12 months
- Patient affiliated to a social security organization
Key exclusion criteria (10 listed)
- Contraindications related to the radiofrequency technique:
- Mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc.
- Neurodegenerative disease with perineal involvement
- Current or recent treatment (within the last 12 months) with other physical methods: vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection or lipo-modeling.
- Pregnant or breast-feeding women
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 |
|---|---|---|
| GynWave-360For patients randomized to the experimental group: 3 sessions of 20 minutes each, spaced 4 to 6 weeks apart (M0, M1, M2) ideally, with +/- 1 maintenance session between 8 and 12 months after the first session (M8-12). | Device | Vaginal radiofrequency treatment |
| Local hydratationReference treatment combining local hydration (hyaluronic acid-based treatment, 3 times a week), with the possibility of using associated measures at the investigator's discretion (physiotherapy, vaginal dilators, etc.). | Other | Reference treatment, Vaginal radiofrequency treatment |
Primary outcome
Numerical scale for vaginal dryness according to patient
Time frame: The main analysis will focus on assessment at 6 months (M6). This endpoint will also be assessed at baseline (M0), 3 and 12 months (M3, M12).
Patient-rated 0-10 Numerical Rating Scale for vaginal dryness, minimum value =0; maximum value = 10; where 0 = No dryness and 10 = Maximum possible dryness.
7 secondary outcomes
Patient-Rated 0-10 numerical scale for dyspareunia
Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS) : vaginal elasticity score
Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS) : vaginal fluid volume score
Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS) : vaginal pH measurement
Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS): vaginal epithelial integrity score
Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS): vaginal moisture score
Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Side effects of radiofrequency treatment
Time frame: through study completion: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 29202940Faubion SS, Sood R, Kapoor E. Genitourinary Syndrome of Menopause: Management Strategies for the Clinician. Mayo Clin Proc. 2017 Dec;92(12):1842-1849. doi: 10.1016/j.mayocp.2017.08.019.
- Background: PubMed 25160739Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014 Oct;21(10):1063-8. doi: 10.1097/GME.0000000000000329.
- Background: PubMed 29411644Moral E, Delgado JL, Carmona F, Caballero B, Guillan C, Gonzalez PM, Suarez-Almarza J, Velasco-Ortega S, Nieto C; as the writing group of the GENISSE study. Genitourinary syndrome of menopause. Prevalence and quality of life in Spanish postmenopausal women. The GENISSE study. Climacteric. 2018 Apr;21(2):167-173. doi: 10.1080/13697137.2017.1421921. Epub 2018 Feb 7.
- Background: PubMed 29987939Simon JA, Davis SR, Althof SE, Chedraui P, Clayton AH, Kingsberg SA, Nappi RE, Parish SJ, Wolfman W. Sexual well-being after menopause: An International Menopause Society White Paper. Climacteric. 2018 Oct;21(5):415-427. doi: 10.1080/13697137.2018.1482647. Epub 2018 Jul 10.
- Background: PubMed 27823751Nappi RE, Cucinella L, Martella S, Rossi M, Tiranini L, Martini E. Female sexual dysfunction (FSD): Prevalence and impact on quality of life (QoL). Maturitas. 2016 Dec;94:87-91. doi: 10.1016/j.maturitas.2016.09.013. Epub 2016 Sep 28.
- Background: PubMed 30029054Kaur N, Gupta A, Sharma AK, Jain A. Survivorship issues as determinants of quality of life after breast cancer treatment: Report from a limited resource setting. Breast. 2018 Oct;41:120-126. doi: 10.1016/j.breast.2018.07.003. Epub 2018 Jul 11.
- Background: PubMed 28277141Oyarzun MFG, Castelo-Branco C. Local hormone therapy for genitourinary syndrome of menopause in breast cancer patients: is it safe? Gynecol Endocrinol. 2017 Jun;33(6):418-420. doi: 10.1080/09513590.2017.1290076. Epub 2017 Feb 21.
- Background: PubMed 35316932Lubian Lopez DM. Management of genitourinary syndrome of menopause in breast cancer survivors: An update. World J Clin Oncol. 2022 Feb 24;13(2):71-100. doi: 10.5306/wjco.v13.i2.71.
- Background: PubMed 27178335Sulaica E, Han T, Wang W, Bhat R, Trivedi MV, Niravath P. Vaginal estrogen products in hormone receptor-positive breast cancer patients on aromatase inhibitor therapy. Breast Cancer Res Treat. 2016 Jun;157(2):203-210. doi: 10.1007/s10549-016-3827-7. Epub 2016 May 13.
- Background: PubMed 14551341Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003 Nov 6;349(19):1793-802. doi: 10.1056/NEJMoa032312. Epub 2003 Oct 9.
- Background: PubMed 16145047Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Pater JL. Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst. 2005 Sep 7;97(17):1262-71. doi: 10.1093/jnci/dji250.
- Background: PubMed 27264120Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. N Engl J Med. 2016 Jul 21;375(3):209-19. doi: 10.1056/NEJMoa1604700. Epub 2016 Jun 5.
- Individual participant dataSharing planned: No
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Atrophic Vaginitis, Atrophic Vulvovaginitis
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.
Julie DEMETZ, MD study director
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GynWave-360 and Local hydratation in people with Vaginal Dryness and Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
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 6 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: looking for participants now, as of the sponsor's last update on 18 Mar 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fanny BEN OUNE (+33320295896, promotion@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical scale for vaginal dryness according to patient (time frame: The main analysis will focus on assessment at 6 months (M6). This endpoint will also be assessed at baseline (M0), 3 and 12 months (M3, M12).). 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 NCT06900374, which also lists 53 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 18 Mar 2026.