Genitourinary Syndrome of Menopause (GSM)NCT07420647
Pilot Study of Individualized Treatment for Genitourinary Syndrome of Menopause in Women After Cancer Treatment
A study testing Non-ablative vaginal Er:YAG laser therapy in people with Genitourinary Syndrome of Menopause (GSM) and Vaginal Dryness, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This pilot study is designed to evaluate an individualized approach to the treatment of genitourinary syndrome of menopause (GSM) in women who have undergone oncological treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause (GSM), Vaginal Dryness, Menopause
- What is being tested?
- Non-ablative vaginal Er:YAG laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Oct 2024to 1 Oct 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex.
- Postmenopausal women.
- History of oncological treatment (e.g., gynecological or other malignancies).
- Presence of genitourinary syndrome of menopause (GSM), including symptoms such as vaginal dryness, dyspareunia, burning, irritation, or urinary symptoms.
- Completion of primary oncological treatment prior to enrollment.
- Age ≥ 18 years.
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Current pregnancy or premenopausal status.
- Active malignant disease requiring ongoing oncological treatment.
- Acute genital or urinary tract infection at the time of enrollment.
- Prior participation in another interventional clinical study that could influence study outcomes.
- Known hypersensitivity or contraindication to study-related interventions.
- Any medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation or outcome assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pilot Project on Individualized Treatment of Genitourinary Syndrome of Menopause in Women After Oncological Treatment: A Prospective Interventional Study
This pilot study is designed to evaluate an individualized approach to the treatment of genitourinary syndrome of menopause (GSM) in women who have undergone oncological treatment. GSM is a common condition in postmenopausal women and may include symptoms such as vaginal dryness, irritation, pain during intercourse, and urinary discomfort. These symptoms can significantly affect quality of life and sexual function, particularly in women after cancer treatment.
The purpose of this study is to assess whether a personalized, non-hormonal treatment approach can effectively reduce GSM symptoms and improve overall quality of life and sexual function in this patient population. Participants will be assigned to an intervention group or a control group and will be followed prospectively over time.
Read more
The study will include women in menopause who have completed oncological treatment and experience symptoms of GSM. Clinical assessments, patient-reported outcomes, and quality-of-life questionnaires will be used to evaluate treatment effectiveness and safety.
The results of this pilot study may help inform future clinical practice and support the development of individualized, non-hormonal treatment strategies for women with GSM after cancer treatment.
- Conditions
- Genitourinary Syndrome of Menopause (GSM), Vaginal Dryness, Menopause, Female Cancer Survivors
- Being tested
- Non-ablative vaginal Er:YAG laser therapy, Standard care
- Keywords
- Genitourinary Syndrome of Menopause, GSM, Vaginal Dryness, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-ablative vaginal Er:YAG laser therapyDevice
Non-ablative vaginal erbium-doped yttrium aluminum garnet (Er:YAG) laser therapy administered for the treatment of genitourinary syndrome of menopause. The intervention consists of three vaginal laser treatments performed at four-week intervals, using standardized laser parameters, without tissue ablation. The procedure is conducted in an outpatient setting.
Non-ablative vaginal Er:YAG laser therapyDevice
Non-ablative vaginal Er:YAG laser therapy administered for the treatment of genitourinary syndrome of menopause. The intervention consists of three vaginal laser treatments performed at four-week intervals, using standardized laser parameters, without tissue ablation. The procedure is conducted in an outpatient setting.
Standard careOther
Standard conservative management according to institutional clinical practice guidelines for genitourinary syndrome of menopause, without laser-based intervention.
| Study group | Role | What they receive |
|---|---|---|
| Individualized GSM Treatment Arm | Experimental | Not described Receives: Device: Non-ablative vaginal Er:YAG laser therapy |
| Standard Care Control Arm | Active comparator | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms
The primary outcome is the change in severity of genitourinary syndrome of menopause (GSM) symptoms following individualized treatment in women after oncological treatment. Symptom severity will be assessed using validated clinical and patient-reported outcome measures, including vaginal dryness, dyspareunia, irritation, and urinary symptoms. Changes will be evaluated by comparing baseline measurements with post-intervention assessments.
Measured: Baseline
Change in Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms
The primary outcome is the change in severity of genitourinary syndrome of menopause (GSM) symptoms following individualized treatment in women after oncological treatment. Symptom severity will be assessed using validated clinical and patient-reported outcome measures, including vaginal dryness, dyspareunia, irritation, and urinary symptoms. Changes will be evaluated by comparing baseline measurements with post-intervention assessments.
Measured: Throughout study completion: 3 times, every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start15 Oct 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Participants are assigned to either an individualized intervention group or a control group receiving standard care, and outcomes are compared between groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420647
- Sponsor's protocol ID
- OI-GSM-2024-01
- Other IDs
- ERID-KSOPR-0060/2024, ERIDEK-0073/2024
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lipovec T, Merlo S, Cilensek I, Kovacevic N. Patient-Reported Outcomes Following Non-Hormonal Treatment of Genitourinary Syndrome of Menopause in Women with Hormone-Dependent Cancer: A Prospective Randomized Pilot Study. Healthcare (Basel). 2026 Sep 10;14(18):2959. doi: 10.3390/healthcare14182959.
PubMed 42793498
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pilot Project on Individualized Treatment of Genitourinary Syndrome of Menopause in Women After Oncological Treatment: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT07420647
- Acronym / sponsor ID
- OI-GSM-2024-01
- Conditions
- Genitourinary Syndrome of Menopause (GSM), Vaginal Dryness, Menopause, Female Cancer Survivors
- Keywords
- Genitourinary Syndrome of Menopause, GSM, Vaginal Dryness, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 19 Feb 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.
This pilot study is designed to evaluate an individualized approach to the treatment of genitourinary syndrome of menopause (GSM) in women who have undergone oncological treatment. GSM is a common condition in postmenopausal women and may include symptoms such as vaginal dryness, irritation, pain during intercourse, and urinary discomfort. These symptoms can significantly affect quality of life and sexual function, particularly in women after cancer treatment.
The purpose of this study is to assess whether a personalized, non-hormonal treatment approach can effectively reduce GSM symptoms and improve overall quality of life and sexual function in this patient population. Participants will be assigned to an intervention group or a control group and will be followed prospectively over time.
The study will include women in menopause who have completed oncological treatment and experience symptoms of GSM. Clinical assessments, patient-reported outcomes, and quality-of-life questionnaires will be used to evaluate treatment effectiveness and safety.
The results of this pilot study may help inform future clinical practice and support the development of individualized, non-hormonal treatment strategies for women with GSM after cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to either an individualized intervention group or a control group receiving standard care, and outcomes are compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Individualized GSM Treatment Arm | Experimental | Device: Non-ablative vaginal Er:YAG laser therapy |
| Standard Care Control Arm | Active comparator | Other: Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female sex.
- Postmenopausal women.
- History of oncological treatment (e.g., gynecological or other malignancies).
- Presence of genitourinary syndrome of menopause (GSM), including symptoms such as vaginal dryness, dyspareunia, burning, irritation, or urinary symptoms.
- Completion of primary oncological treatment prior to enrollment.
Key exclusion criteria (6 listed)
- Current pregnancy or premenopausal status.
- Active malignant disease requiring ongoing oncological treatment.
- Acute genital or urinary tract infection at the time of enrollment.
- Prior participation in another interventional clinical study that could influence study outcomes.
- Known hypersensitivity or contraindication to study-related interventions.
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 |
|---|---|---|
| Non-ablative vaginal Er:YAG laser therapyNon-ablative vaginal erbium-doped yttrium aluminum garnet (Er:YAG) laser therapy administered for the treatment of genitourinary syndrome of menopause. The intervention consists of three vaginal laser treatments performed at four-week intervals, using standardized laser parameters, without tissue ablation. The procedure is conducted in an outpatient setting. | Device | Individualized GSM Treatment Arm |
| Non-ablative vaginal Er:YAG laser therapyNon-ablative vaginal Er:YAG laser therapy administered for the treatment of genitourinary syndrome of menopause. The intervention consists of three vaginal laser treatments performed at four-week intervals, using standardized laser parameters, without tissue ablation. The procedure is conducted in an outpatient setting. | Device | Individualized GSM Treatment Arm |
| Standard careStandard conservative management according to institutional clinical practice guidelines for genitourinary syndrome of menopause, without laser-based intervention. | Other | Standard Care Control Arm |
Primary outcome
Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms
Time frame: Baseline
The primary outcome is the change in severity of genitourinary syndrome of menopause (GSM) symptoms following individualized treatment in women after oncological treatment. Symptom severity will be assessed using validated clinical and patient-reported outcome measures, including vaginal dryness, dyspareunia, irritation, and urinary symptoms. Changes will be evaluated by comparing baseline measurements with post-intervention assessments.
Change in Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms
Time frame: Throughout study completion: 3 times, every 4 weeks
The primary outcome is the change in severity of genitourinary syndrome of menopause (GSM) symptoms following individualized treatment in women after oncological treatment. Symptom severity will be assessed using validated clinical and patient-reported outcome measures, including vaginal dryness, dyspareunia, irritation, and urinary symptoms. Changes will be evaluated by comparing baseline measurements with post-intervention assessments.
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 19 Feb 2026.
- Derived from this study: PubMed 42793498Lipovec T, Merlo S, Cilensek I, Kovacevic N. Patient-Reported Outcomes Following Non-Hormonal Treatment of Genitourinary Syndrome of Menopause in Women with Hormone-Dependent Cancer: A Prospective Randomized Pilot Study. Healthcare (Basel). 2026 Sep 10;14(18):2959. doi: 10.3390/healthcare14182959.
- 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 Non-ablative vaginal Er:YAG laser therapy in people with Genitourinary Syndrome of Menopause (GSM) and Vaginal Dryness, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 19 Feb 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 Slovenia. 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?
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?
Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT07420647, which also lists 1 linked publication.
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 19 Feb 2026.