Vulvo Vaginal AtrophyNCT06828640
Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment
A study testing vaginal dilators in people with Vulvo Vaginal Atrophy and Genitourinary Syndrome of Menopause (GSM), run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy. Study Population: Peri- and postmenopausal women with VVA, including breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Vulvo Vaginal Atrophy, Genitourinary Syndrome of Menopause (GSM), Vaginal Atrophy in Breast Cancer Patients
- What is being tested?
- vaginal dilators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Oct 2024to Oct 2025
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peri- or postmenopausal women suffering from vulvovaginal atrophy (VVA)
- Breast cancer survivors with VVA symptoms
- Understand the study, be willing to participate, and sign an informed consent form.
- The use of estrogen/progestogen-based products (vaginal, oral, pellets, transdermal, etc.) is permitted but must be documented (this will be considered during randomization).
Who cannot join
- Undiagnosed abnormal genital bleeding.
- Administration of any investigational drug within 30 days prior to the screening visit.
- Presence of a serious medical condition, neurological disorder, or significant comorbidities.
- Other gynecological malignancies.
- Recent vaginal surgery.
- Clinically significant prolapse (POP-Q ≤ 2).
Show all 9Show fewer
- Current urinary tract or vaginal infection, or recent sexually transmitted infection.
- Individuals with disabilities unable to communicate.
- Women eligible for the study but unwilling to participate.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Saint Pierre University Hospital Center
Brussels, Brussels Capital, 1000
Julie Piral, medical student, +33673428392, julie.piral@ulb.be
Aurélie Joris, Gynaecologist, +32 2 535 3486, aurelie.joris@stpierre-bru.be
About this study
Official title: Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment : a Randomized Control Trial
This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy.
Study Population:
Read more
Peri- and postmenopausal women with VVA, including breast cancer survivors.
Design: Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group).
Vaginal Dilator : A silicone medical device will be used for gradual stretching progression. The kit includes dilators of progressively larger sizes.
Procedures: Assessments at baseline, at 4 \& 12 weeks
Measures : Vulvo Vaginal Atrophy severity , dyspareunia, Vaginal Health Index Score, Female Sexual Fonction Index, and Visual Analogue Scale (for vaginal dryness, vaginal and/or vulvar irritation/itching, and pain during sexual intercourse).
Statistical Analysis:
Differences at baseline, 4 weeks, and 12 weeks will be tested using:
Two-sample t-test Mann-Whitney test
Statistical Power:
Assuming a 20% improvement in Group 1 and 40% in Group 2, with:
p < 0.05 (type I error) 80% power (type II error), 160 patients needed across both groups.
SoC = Standard of care RCT = Randimized control trial MHT = Menopausal hormonal therapy
- Conditions
- Vulvo Vaginal Atrophy, Genitourinary Syndrome of Menopause (GSM), Vaginal Atrophy in Breast Cancer Patients, Vaginal Atrophy Patients With GSM, Treatment, Sexual Disfunction
- Being tested
- vaginal dilators
- Keywords
- Vulvo vaginal atrophy, vaginal dilators, Genitourinary syndrome of menopause, treatment
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal dilatorsDevice
Evaluate the efficacy of vaginal dilators as an addition to Standard of Care in premenopausal or menopausal women, including breast cancer survivors
| Study group | Role | What they receive |
|---|---|---|
| Test Group : vaginal dilators | Experimental | A Test group receiving the standard treatment + a kit of vaginal dilators with progressively larger sizes. Receives: Device: vaginal dilators |
| Control Group : placebo | No intervention | A control group receiving the standard treatment (which includes MHT, vaginal lubricants, and Moisturizers). |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Vaginal dryness score
- None: no feeling of dryness.
- Mild: occasional feeling of dryness that does not interfere with daily activities.
- Moderate: feeling dry most of the time but does not interfere with daily activities.
- Severe: continuous feeling of dryness interfering with daily activities.
Measured: At baseline, 4 and 12 weeks
• Vaginal and/or vulvar irritation/itching
- None: no feeling of irritation.
- Mild: occasional irritating sensation that does not interfere with daily activities.
- Moderate: feeling irritated most of the time but does not interfere with daily activities.
- Severe: continuous feeling of irritation interfering with daily activities.
Measured: At baseline, 4 and 12 weeks
• Pain during sexual intercourse score
- None: pleasant sexual intercourse, rare pain.
- Mild: occasional pain, not during every sexual intercourse, intercourse should be interrupted occasionally.
- Moderate: most of the time, little satisfaction during intercourse and it often has to be interrupted.
- Severe: during each sexual intercourse, no pleasure during intercourse and these must often be interrupted. Often post-coital bleeding. Frequent abstinence due to pain.
Measured: At baseline, 4 and 12 weeks
Vaginal Health index score
The vaginal health score (VHIS) consists of analyzing five vaginal parameters: Vaginal elasticity; Volume of vaginal secretions; vaginal pH; the integrity of the epithelium of the vaginal walls and the lubrication/hydration of the vagina.
For each vaginal parameter we give a score ranging from 1 to 5 The VHIS score is obtained by adding all the scores obtained (minimum score = 5 and maximum score = 25.
If VHIS <15, the vagina is considered atrophic.
Measured: at baseline and 12 weeks
Patient satisfaction : visual analogue scale
Evaluation of symptoms linked to vaginal atrophy (dryness, irritation, dyspareunia) on a visual analogue scale for pain (0 to 10) 0 = symptoms absent 10 = unbearable symptoms
Measured: At baseline, 4 and 12 weeks
Quality of life questionnaire specific to genitourinary syndrome
Answer yes or no :
Over the past week, have you been bothered by:
Itchy vulva? Burning or tingling in the vulva? Pain in the vulva? Irritations to the vulva? Dryness in the vulva? Unpleasant vulvar or vaginal discharge? Odors coming from your vulva or vagina? Are you worried about your vulvar symptoms? (for example, will it spread, get worse, leave scars? etc.) Frustrations about your vulvar symptoms? Embarrassment about your vulvar symptoms? How do your vulvar symptoms affect your interactions with others? How do your vulvar symptoms affect your desire to be with people? Do your vulvar symptoms prevent you from showing affection? How do your vulvar symptoms affect your daily activities? Do your vulvar symptoms prevent you from having intimate relationships? The effects of your vulvar symptoms on your sexual relations? Do your vulvar symptoms cause pain during sexual activity? Do your vulvar symptoms cause dryness during sexual activity?
Measured: At baseline, 4 and 12 weeks
Female Sexual Function Index (FSFI) questionnaire
- Desire Question :1, 2 Score range (1 - 5 ) min score 1.2 max score 6.0
- Arousal Question : 3, 4, 5, 6 Score range( 0 - 5) min score : 0 Max score : 6.0
- Lubrication: Question 7, 8, 9, 10 Score range(0 - 5) min score : 0 max score : 6.0
- Orgasm : Question 11, 12, 13 Score range (0 - 5) min score 0 max score : 6.0
- Satisfaction: Question : 14, 15, 16 Score range (0 (or 1) - 5) min score : 0.8 max score : 6.0
- Pain : Question : 17, 18, 19 Score range(0 - 5) min score : 0 max score : 6.0
Full Scale Score Range minimum score : 2.0 maximum score : 36.0
Measured: At baseline, 4 and 12 weeks
Secondary outcomes (2)
Number of participants with treatment-related adverse events
Did you experience any side effects or discomfort related to the procedure?
- Yes
- No → If yes, can you specify which ones? 8. Have you considered stopping the procedure at any point?
- Yes
- No
Measured: At 4 and 12 weeks
Rate of adherence to the study by patients
Was the intervention compatible with your lifestyle?
- Yes, absolutely
- Rather yes
- Rather no
- No, not at all 10. Did you encounter any obstacles in following the intervention?
- Yes
- No → If yes, can you specify which ones?
Measured: At 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start16 Oct 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (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 Vulvo Vaginal AtrophyStudies 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
- Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group). SoC = Standard of care RCT = randomized control trial MHT = Menopausal hormonal therapy
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge Rozenberg, Gynaecologist, Study director, Saint Pierre University Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828640
- Sponsor's protocol ID
- B0762024240710
- Status last verified
- Aug 2024
- First submitted
- 4 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Publications
Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013 Jul;10(7):1790-9. doi: 10.1111/jsm.12190. Epub 2013 May 16.
PubMed 23679050
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment : a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06828640
- Acronym / sponsor ID
- B0762024240710
- Conditions
- Vulvo Vaginal Atrophy, Genitourinary Syndrome of Menopause (GSM), Vaginal Atrophy in Breast Cancer Patients, Vaginal Atrophy Patients With GSM, Treatment, Sexual Disfunction
- Keywords
- Vulvo vaginal atrophy, vaginal dilators, Genitourinary syndrome of menopause, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 14 Feb 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 is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy.
Study Population:
Peri- and postmenopausal women with VVA, including breast cancer survivors.
Design: Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group).
Vaginal Dilator : A silicone medical device will be used for gradual stretching progression. The kit includes dilators of progressively larger sizes.
Procedures: Assessments at baseline, at 4 \& 12 weeks
Measures : Vulvo Vaginal Atrophy severity , dyspareunia, Vaginal Health Index Score, Female Sexual Fonction Index, and Visual Analogue Scale (for vaginal dryness, vaginal and/or vulvar irritation/itching, and pain during sexual intercourse).
Statistical Analysis:
Differences at baseline, 4 weeks, and 12 weeks will be tested using:
Two-sample t-test Mann-Whitney test
Statistical Power:
Assuming a 20% improvement in Group 1 and 40% in Group 2, with:
p < 0.05 (type I error) 80% power (type II error), 160 patients needed across both groups.
SoC = Standard of care RCT = Randimized control trial MHT = Menopausal hormonal therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group). SoC = Standard of care RCT = randomized control trial MHT = Menopausal hormonal therapy
| Arm | Type | Receives |
|---|---|---|
| Test Group : vaginal dilators | Experimental | Device: vaginal dilatorsA Test group receiving the standard treatment + a kit of vaginal dilators with progressively larger sizes. |
| Control Group : placebo | No intervention | –A control group receiving the standard treatment (which includes MHT, vaginal lubricants, and Moisturizers). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Peri- or postmenopausal women suffering from vulvovaginal atrophy (VVA)
- Breast cancer survivors with VVA symptoms
- Understand the study, be willing to participate, and sign an informed consent form.
- The use of estrogen/progestogen-based products (vaginal, oral, pellets, transdermal, etc.) is permitted but must be documented (this will be considered during randomization).
Key exclusion criteria (9 listed)
- Undiagnosed abnormal genital bleeding.
- Administration of any investigational drug within 30 days prior to the screening visit.
- Presence of a serious medical condition, neurological disorder, or significant comorbidities.
- Other gynecological malignancies.
- Recent vaginal surgery.
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 |
|---|---|---|
| vaginal dilatorsEvaluate the efficacy of vaginal dilators as an addition to Standard of Care in premenopausal or menopausal women, including breast cancer survivors | Device | Test Group : vaginal dilators |
Primary outcome
• Vaginal dryness score
Time frame: At baseline, 4 and 12 weeks
* None: no feeling of dryness. * Mild: occasional feeling of dryness that does not interfere with daily activities. * Moderate: feeling dry most of the time but does not interfere with daily activities. * Severe: continuous feeling of dryness interfering with daily activities.
• Vaginal and/or vulvar irritation/itching
Time frame: At baseline, 4 and 12 weeks
* None: no feeling of irritation. * Mild: occasional irritating sensation that does not interfere with daily activities. * Moderate: feeling irritated most of the time but does not interfere with daily activities. * Severe: continuous feeling of irritation interfering with daily activities.
• Pain during sexual intercourse score
Time frame: At baseline, 4 and 12 weeks
* None: pleasant sexual intercourse, rare pain. * Mild: occasional pain, not during every sexual intercourse, intercourse should be interrupted occasionally. * Moderate: most of the time, little satisfaction during intercourse and it often has to be interrupted. * Severe: during each sexual intercourse, no pleasure during intercourse and these must often be interrupted. Often post-coital bleeding. Frequent abstinence due to pain.
Vaginal Health index score
Time frame: at baseline and 12 weeks
The vaginal health score (VHIS) consists of analyzing five vaginal parameters: Vaginal elasticity; Volume of vaginal secretions; vaginal pH; the integrity of the epithelium of the vaginal walls and the lubrication/hydration of the vagina. For each vaginal parameter we give a score ranging from 1 to 5 The VHIS score is obtained by adding all the scores obtained (minimum score = 5 and maximum score = 25. If VHIS <15, the vagina is considered atrophic.
Patient satisfaction : visual analogue scale
Time frame: At baseline, 4 and 12 weeks
Evaluation of symptoms linked to vaginal atrophy (dryness, irritation, dyspareunia) on a visual analogue scale for pain (0 to 10) 0 = symptoms absent 10 = unbearable symptoms
Quality of life questionnaire specific to genitourinary syndrome
Time frame: At baseline, 4 and 12 weeks
Answer yes or no : Over the past week, have you been bothered by: Itchy vulva? Burning or tingling in the vulva? Pain in the vulva? Irritations to the vulva? Dryness in the vulva? Unpleasant vulvar or vaginal discharge? Odors coming from your vulva or vagina? Are you worried about your vulvar symptoms? (for example, will it spread, get worse, leave scars? etc.) Frustrations about your vulvar symptoms? Embarrassment about your vulvar symptoms? How do your vulvar symptoms affect your interactions with others? How do your vulvar symptoms affect your desire to be with people? Do your vulvar symptoms prevent you from showing affection? How do your vulvar symptoms affect your daily activities? Do your vulvar symptoms prevent you from having intimate relationships? The effects of your vulvar symptoms on your sexual relations? Do your vulvar symptoms cause pain during sexual activity? Do your vulvar symptoms cause dryness during sexual activity?
Female Sexual Function Index (FSFI) questionnaire
Time frame: At baseline, 4 and 12 weeks
* Desire Question :1, 2 Score range (1 - 5 ) min score 1.2 max score 6.0 * Arousal Question : 3, 4, 5, 6 Score range( 0 - 5) min score : 0 Max score : 6.0 * Lubrication: Question 7, 8, 9, 10 Score range(0 - 5) min score : 0 max score : 6.0 * Orgasm : Question 11, 12, 13 Score range (0 - 5) min score 0 max score : 6.0 * Satisfaction: Question : 14, 15, 16 Score range (0 (or 1) - 5) min score : 0.8 max score : 6.0 * Pain : Question : 17, 18, 19 Score range(0 - 5) min score : 0 max score : 6.0 Full Scale Score Range minimum score : 2.0 maximum score : 36.0
2 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: At 4 and 12 weeks
Rate of adherence to the study by patients
Time frame: At 4 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Background: PubMed 23679050Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013 Jul;10(7):1790-9. doi: 10.1111/jsm.12190. Epub 2013 May 16.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
Related trials for Vulvo Vaginal Atrophy
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
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
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer
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.
Serge Rozenberg, Gynaecologist study director
Saint Pierre University Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal dilators in people with Vulvo Vaginal Atrophy and Genitourinary Syndrome of Menopause (GSM), run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 9 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: status not confirmed, as of the sponsor's last update on 14 Feb 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Piral, medical student (+33673428392, julie.piral@ulb.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Vaginal dryness score (time frame: At baseline, 4 and 12 weeks). The study lists 7 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 NCT06828640, 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 14 Feb 2025.