An observational study in Vaginal Atrophy, sponsored by Perfect Care Distribution. Completed at 14 sites in Romania. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Perfect Care Distribution · Observational
An open-label, multicentric, non-randomized, single-arm, pilot, interventional clinical investigation to confirm the tolerability and performance of the medical device Halova in lubrication of the vagina and vaginal atrophy treatment.
The primary objective of this investigation is to evaluate the therapeutic performance and tolerability of Halova ovules in treating vaginal atrophy and restoring the natural lubrication of the vaginal mucosa.
The secondary objective of this clinical investigation are to evaluate the performance of the medical device by clinical examination, and the degree of patient satisfaction related to the intended use (Likert scale).
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's enrollment of 249 is above the median of 165 across 30 observational studies indexed under Dyspareunia.
Browse Dyspareunia studies →Perfect Care Distribution is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult women, with atrophic vaginitis caused by estrogen hormone deficiency or vaginal dryness as a result of contraceptive treatment or other disorders.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Halova is a class I medical device formulated as vaginal ovules and intended for intravaginal administration in order to promote and/or accelerate the hydration, healing, re-epithelialization and/or soothing of injured, atrophic or irritated vaginal mucosa. The ovules melt evenly in the vaginal mucosa forming a cream with a moisturizing and calming effect that support the restoration of the vaginal epithelium.
Rating and assessing of treatment-related Adverse Events
The safety of Halova® ovules as measured by the rate of treatment-related adverse events, including serious adverse events (SAEs), in subjects participating in the clinical investigation
Time frame: 30 days
Clinical Performance
Evaluation by the Investigator of the disorder-related symptoms
Time frame: 30 days
Patient Satisfaction
The degree of satisfaction when using the medical device will be assessed using a five-point Likert Scale from Very satisfied to Very unsatisfied
Time frame: 30 days
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Perfect Care Distribution