An interventional study of vaginal dilators in Vulvo Vaginal Atrophy, Genitourinary Syndrome of Menopause (GSM) and Vaginal Atrophy in Breast Cancer Patients, sponsored by Centre Hospitalier Universitaire Saint Pierre. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Centre Hospitalier Universitaire Saint Pierre · Not applicable, Interventional, and Treatment
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
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's planned enrollment of 160 is above the median of 63 across 126 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →Centre Hospitalier Universitaire Saint Pierre is the lead sponsor of 78 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A Test group receiving the standard treatment + a kit of vaginal dilators with progressively larger sizes.
Device: vaginal dilators
A control group receiving the standard treatment (which includes MHT, vaginal lubricants, and Moisturizers).
Evaluate the efficacy of vaginal dilators as an addition to Standard of Care in premenopausal or menopausal women, including breast cancer survivors
• 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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?
Time frame: 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
Time frame: At baseline, 4 and 12 weeks
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
Time frame: 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?
Time frame: At 4 and 12 weeks
Plan to share: Yes — all collected IPD, all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: October 2024 -2025 : 1 year
Access criteria: on request
Started Oct 2024 (actual). Primary completion is estimated for Oct 2025, 12 months after the start.
Of 51 non-industry interventional studies with no phase under Dyspareunia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 59 studies reached it within 33 months; a quarter within 13 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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Centre Hospitalier Universitaire Saint Pierre