Genitourinary Syndrome of Menopause (GSM)NCT07034976
Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)
A study testing Active Radiofrequency (Capenergy C500 UpGradeC200) in people with Genitourinary Syndrome of Menopause (GSM) and Breast Cancer, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The goal of this clinical trial is to find out whether non-ablative radiofrequency (RF) applied together with pelvic-floor muscle exercises can ease vaginal dryness and other symptoms of genitourinary syndrome of menopause (GSM) in women aged 18-75 years who have survived breast cancer and currently experience those… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause (GSM), Breast Cancer
- What is being tested?
- Active Radiofrequency (Capenergy C500 UpGradeC200)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 31 Dec 2027
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are breast cancer survivors and clinically confirmed to be disease-free by their physician.
- Amenorrhea for more than 12 months and vaginal pH ≥ 5, with symptoms related to genitourinary syndrome of menopause (GSM), as diagnosed by a physician. Symptoms must be bothersome and not better explained by another clinical condition.
- Negative urine culture at baseline.
- Moderate to severe vaginal dryness, defined as a score > 4 on the Numeric Rating Scale (NRS 0-10)
Who cannot join
- Age over 75 years.
- Current or past diagnosis of any cancer other than breast cancer.
- Pelvic surgery, chemotherapy, or radiotherapy in the past 3 months.
- Use of local estrogen therapy within the past month.
- Active genital infections.
- Diagnosis of HIV infection or severe immunosuppression.
Show all 15Show fewer
- Presence of pacemakers, metallic implants, or electromagnetic devices.
- Coagulation disorders or current use of anticoagulants.
- Pelvic organ prolapse stage > III (POP-Q classification).
- Unexplained abnormal vaginal bleeding.
- History of pelvic anti-incontinence surgery, with or without mesh.
- Inflammatory dermatoses of the vulva.
- Pelvic-floor muscle strength score of 0/5 on the Modified Oxford Scale.
- Nickel allergy.
- Previous treatment with radiofrequency in the pelvic or genital area.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Irene Lázaro Navas, PhD, MSc, PT, +34 913368000, irenelazarofisioterapia@gmail.com
About this study
Official title: Randomized, Controlled Trial to Evaluate the Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training on Symptoms of Genitourinary Syndrome of Menopause in Breast Cancer Survivors
The goal of this clinical trial is to find out whether non-ablative radiofrequency (RF) applied together with pelvic-floor muscle exercises can ease vaginal dryness and other symptoms of genitourinary syndrome of menopause (GSM) in women aged 18-75 years who have survived breast cancer and currently experience those symptoms.
The main questions it aims to answer are:
Read more
Does the combination of RF + exercise lower the 0-to-10 vaginal-dryness score more than sham (inactive) RF + exercise at 6 weeks (end of treatment) and 3 months?
What other changes (pain during intercourse, Vaginal Health Index, urinary and sexual function, pelvic-floor strength, overall satisfaction) are seen in each group?
Researchers will compare six sessions of active RF with six sessions of sham (inactive) RF to see whether the active treatment works better.
Participants will:
Visit the hospital once a week for 6 weeks. Each visit includes about 20 minutes of intra-/extra-vaginal RF (or sham) and 20 minutes of guided pelvic-floor training whose content is adapted and progressed throughout the study.
Carry out a structured, progressive home-exercise programme, recording any discomfort in a diary.
Complete questionnaires and tests at baseline, after session 6, and 3 months later.
- Being tested
- Active Radiofrequency (Capenergy C500 UpGradeC200), Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)
- Keywords
- genitourinary syndrome of menopause, vaginal atrophy, vaginal dryness, breast cancer survivors, non-ablative radiofrequency, pelvic floor muscle training, physiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Radiofrequency (Capenergy C500 UpGradeC200)Device
Non-ablative radiofrequency is applied using a Capenergy C500 device at a target tissue temperature of ≤ 45 °C, once a week for 6 consecutive weeks. Treatment is delivered through two channels simultaneously: a capacitive plate placed on the suprapubic area and an intracavitary vaginal probe. Each session lasts 20 minutes and is followed by 20 minutes of pelvic-floor muscle training guided by biofeedback. Participants will also follow a progressive home exercise programme and record adherence and events.
In addition, all participants will receive education on pelvic-floor anatomy and function, underlying mechanisms of pain after breast cancer, bladder and bowel retraining, respiratory pattern re-education, and-if interested-information on sexual health.
Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)Device
Participants will receive one session per week for 6 weeks of sham (placebo) radiofrequency using the Capenergy C500 in Placebo Mode (no temperature increase), designed to simulate active treatment. The screen will display a simulated "delivered energy" value; temperature and energy readings will be hidden; LED indicators will activate sequentially; and a suprapubic capacitive plate and intracavitary probe will be used with the same protocol as in the intervention group. This will be followed by 20 minutes of pelvic-floor muscle training guided by biofeedback, identical to the intervention group. Participants will also follow a progressive home exercise programme and record adherence and events. All participants will receive education on pelvic-floor function, pain mechanisms after breast cancer, bladder/bowel retraining, breathing pattern correction, and-if interested-sexual health.
| Study group | Role | What they receive |
|---|---|---|
| Active Non-ablative Radiofrequency + Pelvic-Floor Muscle Training | Experimental | Participants in this group will receive non-ablative monopolar capacitive radiofrequency therapy combined with pelvic-floor muscle training guided by biofeedback. Receives: Device: Active Radiofrequency (Capenergy C500 UpGradeC200) |
| Sham Radiofrequency + Pelvic-Floor Muscle Training | Sham comparator | Participants in this group will receive sham radiofrequency treatment combined with pelvic-floor muscle training guided by biofeedback. Receives: Device: Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective sensation of vaginal dryness
Measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates "no dryness" and 10 indicates "maximum dryness". The NRS is a self-reported, single-item scale commonly used for subjective symptom intensity.
Measured: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Secondary outcomes (15)
Subjective sensation of pain during sexual activity (NRS 0-10)
Measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "maximum pain during sexual activity". The NRS is a self-reported, single-item scale commonly used for subjective symptom intensity.
Measured: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Subjective sensation of vaginal itching (NRS 0-10)
Measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates "no itching" and 10 indicates "maximum itching". The NRS is a self-reported, single-item scale commonly used for subjective symptom intensity.
Measured: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Vaginal Health Index Score
The Vaginal Health Index Score assesses five parameters (elasticity, secretions, epithelial integrity, moisture, and pH), each rated from 1 to 5. The total score ranges from 5 (worst condition) to 25 (optimal vaginal health).
Measured: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Female Sexual Function Index total score
The FSFI is a 19-item self-reported questionnaire evaluating six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores range from 2 to 36. A score below 26.55 is considered indicative of sexual dysfunction based on established clinical cutoffs.
Measured: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Vaginal pH level
The pH will be quantified using MColorpHast™ pH indicator strips (0-14 range, Merck®). The strip will be placed directly on the right lateral vaginal wall for a few seconds, and the result will be determined by comparing the colour to the manufacturer's reference scale. Higher pH values are typically associated with hypoestrogenic states and genitourinary symptoms of menopause
Measured: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Pelvic organ support parameters measured by POP-Q system
Pelvic anatomy will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system, with the patient in gynecological position and using a speculum. The following parameters will be recorded: genital hiatus (GH), perineal body (PB), total vaginal length (TVL), and reference points Aa, Ba, C, D, Ap, and Bp.
Measured: T0 (baseline, before intervention); T2 (3 months after T1)
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF total score)
The ICIQ-SF is a self-reported questionnaire assessing the frequency, severity, and impact of urinary incontinence. Scores range from 0 to 21, with higher scores indicating greater severity.
Measured: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
ICIQ-FLUTS
The ICIQ-FLUTS (International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms) is a self-administered questionnaire designed to evaluate female lower urinary tract symptoms (LUTS) and their impact on quality of life. It consists of 12 items grouped into three independent domains: storage symptoms, voiding symptoms, and incontinence symptoms. Each item assesses the presence and perceived severity of the symptom
Measured: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Pelvic-floor muscle strength (Modified Oxford Scale, 0-5)
Assessed by vaginal palpation using the Modified Oxford Scale, which rates voluntary pelvic-floor muscle contraction from 0 (no contraction) to 5 (strong contraction). This is a validated, clinician-administered tool.
Measured: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Pelvic-floor muscle activity measured by surface electromyography (μV)
Pelvic-floor muscle activation is measured using surface electromyography (sEMG) with an intracavitary Periform® vaginal probe. The outcome is expressed in microvolts (μV) and reflects the neuromuscular response of the pelvic floor during both contraction and resting phases. For each participant, the final value will be calculated as the mean of three voluntary contractions, with 10-second rest intervals between contractions
Measured: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Subjective global impression of improvement (7-point Likert scale)
Participants will be asked to rate their overall perception of improvement in symptoms after the intervention using a 7-point Likert scale, specifically designed for this study and based on the Patient Global Impression of Change (PGIC). The scale ranges from 1 ("very much improved") to 7 ("very much worse"), reflecting the participant's subjective global impression of improvement compared to their baseline condition.
Measured: T1 (immediately after completing the intervention); T2 (3 months after T1)
Incidence of adverse events related to the intervention
Any unexpected or undesired sign, symptom, or condition temporally associated with the intervention will be recorded
Measured: T1 (immediately after completing the intervention); T2 (3 months after T1)
Adherence to prescribed home pelvic-floor training
Measured through a self-reported diary where participants record the frequency and completion of home-based pelvic-floor exercises. Adherence is expressed as a percentage of the total prescribed sessions completed.
Measured: T1 (immediately after completing the intervention); T2 (3 months after T1)
Local recurrence of breast cancer at 12 months
Oncological follow-up will document any confirmed local breast cancer recurrence occurring within 12 months of completing the intervention.
Measured: 12 months after T1
Participant's belief regarding group allocation (intervention vs. placebo)
At the end of the intervention, participants will be asked whether they believe they received the active treatment or the placebo treatment.
Measured: T1 (immediately after completing the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of Menopause (GSM)Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Ramon y Cajal
- Responsible party
- Principal investigator, Irene Lázaro Navas, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034976
- Sponsor's protocol ID
- 069/25
- Other IDs
- IMP24_B01
- Status last verified
- Jul 2025
- First submitted
- 27 May 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) has not been finalized. Any future data sharing will follow applicable ethical, legal, and institutional guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial to Evaluate the Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training on Symptoms of Genitourinary Syndrome of Menopause in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07034976
- Acronym / sponsor ID
- 069/25
- Keywords
- genitourinary syndrome of menopause, vaginal atrophy, vaginal dryness, breast cancer survivors, non-ablative radiofrequency, pelvic floor muscle training, physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Hospital Universitario Ramon y Cajal
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Jun 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.
The goal of this clinical trial is to find out whether non-ablative radiofrequency (RF) applied together with pelvic-floor muscle exercises can ease vaginal dryness and other symptoms of genitourinary syndrome of menopause (GSM) in women aged 18-75 years who have survived breast cancer and currently experience those symptoms.
The main questions it aims to answer are:
Does the combination of RF + exercise lower the 0-to-10 vaginal-dryness score more than sham (inactive) RF + exercise at 6 weeks (end of treatment) and 3 months?
What other changes (pain during intercourse, Vaginal Health Index, urinary and sexual function, pelvic-floor strength, overall satisfaction) are seen in each group?
Researchers will compare six sessions of active RF with six sessions of sham (inactive) RF to see whether the active treatment works better.
Participants will:
Visit the hospital once a week for 6 weeks. Each visit includes about 20 minutes of intra-/extra-vaginal RF (or sham) and 20 minutes of guided pelvic-floor training whose content is adapted and progressed throughout the study.
Carry out a structured, progressive home-exercise programme, recording any discomfort in a diary.
Complete questionnaires and tests at baseline, after session 6, and 3 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Non-ablative Radiofrequency + Pelvic-Floor Muscle Training | Experimental | Device: Active Radiofrequency (Capenergy C500 UpGradeC200)Participants in this group will receive non-ablative monopolar capacitive radiofrequency therapy combined with pelvic-floor muscle training guided by biofeedback. |
| Sham Radiofrequency + Pelvic-Floor Muscle Training | Sham comparator | Device: Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)Participants in this group will receive sham radiofrequency treatment combined with pelvic-floor muscle training guided by biofeedback. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women who are breast cancer survivors and clinically confirmed to be disease-free by their physician.
- Amenorrhea for more than 12 months and vaginal pH ≥ 5, with symptoms related to genitourinary syndrome of menopause (GSM), as diagnosed by a physician. Symptoms must be bothersome and not better explained by another clinical condition.
- Negative urine culture at baseline.
- Moderate to severe vaginal dryness, defined as a score > 4 on the Numeric Rating Scale (NRS 0-10)
Key exclusion criteria (15 listed)
- Age over 75 years.
- Current or past diagnosis of any cancer other than breast cancer.
- Pelvic surgery, chemotherapy, or radiotherapy in the past 3 months.
- Use of local estrogen therapy within the past month.
- Active genital infections.
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 |
|---|---|---|
| Active Radiofrequency (Capenergy C500 UpGradeC200)Non-ablative radiofrequency is applied using a Capenergy C500 device at a target tissue temperature of ≤ 45 °C, once a week for 6 consecutive weeks. Treatment is delivered through two channels simultaneously: a capacitive plate placed on the suprapubic area and an intracavitary vaginal probe. Each session lasts 20 minutes and is followed by 20 minutes of pelvic-floor muscle training guided by biofeedback. Participants will also follow a progressive home exercise programme and record adherence and events. In addition, all participants will receive education on pelvic-floor anatomy and function, underlying mechanisms of pain after breast cancer, bladder and bowel retraining, respiratory pattern re-education, and-if interested-information on sexual health. | Device | Active Non-ablative Radiofrequency + Pelvic-Floor Muscle Training |
| Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)Participants will receive one session per week for 6 weeks of sham (placebo) radiofrequency using the Capenergy C500 in Placebo Mode (no temperature increase), designed to simulate active treatment. The screen will display a simulated "delivered energy" value; temperature and energy readings will be hidden; LED indicators will activate sequentially; and a suprapubic capacitive plate and intracavitary probe will be used with the same protocol as in the intervention group. This will be followed by 20 minutes of pelvic-floor muscle training guided by biofeedback, identical to the intervention group. Participants will also follow a progressive home exercise programme and record adherence and events. All participants will receive education on pelvic-floor function, pain mechanisms after breast cancer, bladder/bowel retraining, breathing pattern correction, and-if interested-sexual health. | Device | Sham Radiofrequency + Pelvic-Floor Muscle Training |
Primary outcome
Subjective sensation of vaginal dryness
Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates "no dryness" and 10 indicates "maximum dryness". The NRS is a self-reported, single-item scale commonly used for subjective symptom intensity.
15 secondary outcomes
Subjective sensation of pain during sexual activity (NRS 0-10)
Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Subjective sensation of vaginal itching (NRS 0-10)
Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Vaginal Health Index Score
Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Female Sexual Function Index total score
Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Vaginal pH level
Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Pelvic organ support parameters measured by POP-Q system
Time frame: T0 (baseline, before intervention); T2 (3 months after T1)
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF total score)
Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
ICIQ-FLUTS
Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Pelvic-floor muscle strength (Modified Oxford Scale, 0-5)
Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Pelvic-floor muscle activity measured by surface electromyography (μV)
Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Subjective global impression of improvement (7-point Likert scale)
Time frame: T1 (immediately after completing the intervention); T2 (3 months after T1)
Incidence of adverse events related to the intervention
Time frame: T1 (immediately after completing the intervention); T2 (3 months after T1)
Adherence to prescribed home pelvic-floor training
Time frame: T1 (immediately after completing the intervention); T2 (3 months after T1)
Local recurrence of breast cancer at 12 months
Time frame: 12 months after T1
Participant's belief regarding group allocation (intervention vs. placebo)
Time frame: T1 (immediately after completing the intervention)
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 15 Sep 2025.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) has not been finalized. Any future data sharing will follow applicable ethical, legal, and institutional guidelines.
Related trials for Genitourinary Syndrome of Menopause (GSM)
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
Not yet recruiting
Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
Genitourinary Syndrome of Menopause (GSM), Bacterial Vaginosis
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer
Recruiting
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Radiofrequency (Capenergy C500 UpGradeC200) in people with Genitourinary Syndrome of Menopause (GSM) and Breast Cancer, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 15 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 15 Sep 2025. 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 Spain. 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. Some participants in this study may receive a placebo. 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 Irene Lázaro Navas, PhD, MSc, PT (+34 91 336 83 22, ilazaro@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective sensation of vaginal dryness (time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2025.