An interventional study of Health care product (intimate gel) in Atrophic Vaginitis and Vaginal Diseases, sponsored by Herbarium Laboratorio Botanico Ltda. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-02.
Sponsored by Herbarium Laboratorio Botanico Ltda · Not applicable, Interventional, and Treatment
The research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days. Will be evaluated and followed up throughout the study by a gynecologist to verify the safety and effectiveness of the product and possible adverse events.
The study will evaluate the non-interference of a topical use product on the intimate area, helping to preserve the natural defenses. In addition, the epithelial hydration and pH of the intimate area will be evaluated.
74 female participants, 18 to 59 years of age, healthy with complaints of vaginal dryness. The subjects will be submitted to gynecological evaluation in which pH measurements, hydration measurements and bacterioscopic collection will be performed. Then they will be guided to answer the questionnaires of Perceived Efficacy and Quality of Sexual Life. Next, participants will receive the product for home use, under real conditions of use, for 28 ± 2 days. After 28 ± 2 days of use, subjects will return to the institute, and undergo further evaluations with the gynecologist. New pH measurements, hydration measurements (chronometry), bacterioscopic collection will be performed and the participants will answer the Perceived Efficacy and Quality of Sexual Life questionnaires.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's enrollment of 74 is close to the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →Herbarium Laboratorio Botanico Ltda is the lead sponsor of 11 studies on the registry; 2 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.
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.
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.
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.
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.
74 female subjects, 18 to 59 years of age, healthy with complaints of vaginal dryness that will receive the heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days.
Other: Health care product (intimate gel)
heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days
Perceived Hydration
Evaluate the perceived hydration through a subjective questionnaire
Time frame: 28 ± 2 days
Hydration (device)
Evaluate the hydration, through a hydration measurements by chronometry.
Time frame: 28 ± 2 days
Natural defenses preservation (pH)
pH measurements
Time frame: 28 ± 2 days
Natural defenses preservation (microbiota)
bacterioscopic collection
Time frame: 28 ± 2 days
Ran from Apr 2021 to primary completion in Jul 2021, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Herbarium Laboratorio Botanico Ltda