A Phase 3 interventional study of 0.20% sodium hyaluronate gel in Vaginismus, Vaginal Atrophy and Menopause, sponsored by Biolab Sanus Farmaceutica. Not yet recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Biolab Sanus Farmaceutica · Phase 3, Interventional, and Treatment
Hyaluronic Acid is indicated for the relief of vaginal dryness, itching, and irritation, or the reduction of vaginal lubrication with prolonged hydration effects for up to 72 hours. Hyaluronic Acid promotes vaginal moisture, providing symptom relief in various situations such as:
29 studies on the registry are indexed under Vaginismus; 9 are open to participants now.
This study's planned enrollment of 45 is above the median of 40 across 23 interventional studies indexed under Vaginismus.
Browse Vaginismus studies →Biolab Sanus Farmaceutica is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hyaluronic Acid will applied under recommended conditions during the period of T22 ±2 days.
Device: 0.20% sodium hyaluronate gel
Hyaluronic Acid is indicated for the relief of vaginal dryness, itching, and irritation, or the reduction of vaginal lubrication with prolonged hydration effects for up to 72 hours.
Also known as: Hyaluronic Acid
Verify the hydration of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel
To evaluate the perceived hydration effectiveness, a visual analogue scale will be used, where the minimum value (zero) represents no dryness and the maximum value (ten) represents extremely dryness. Lower scores indicate improved vaginal hydration.
Time frame: 22 days
Verify the acceptability of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel
To assess skin acceptability, an epithelial integrity questionnaire will be used, where a score, on a 5-point scale, will be assigned after evaluation by the gynecologist. The lowest score will be 1, representing "petechiae before contact" and the maximum score will be 5 with "thin, non-friable mucosa". The higher the score, the healthier and more intact the epithelium will be.
Time frame: 22 days
Relief of pruritus after using hyaluronic acid-based vaginal gel
The relief of pruritus assessment will be evaluates through an Visual Analogic Scale. Where the minimum value (zero) represents no pruritus and the maximum value (ten) represents extremely pruritus. Lower scores indicate improvement or absence of vaginal pruritus.
Time frame: 22 days
Verify the maintenance of pH after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.
pH maintenance will be assessed using reagent strips.
Time frame: 22 days
Verify the maintenance of vaginal microbiota after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.
Bacterioscopic collection of vaginal contents using a sterile swab. The swabs containing the samples will be placed in test tubes sent to the laboratory for microbiological analysis.
Time frame: 22 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for Sep 2025, 6 months later.
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This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Biolab Sanus Farmaceutica