Vaginal AtrophyNCT05654610
Real-world Evidence Study on the Performance and Safety of Halova Ovules
An observational study of Vaginal Atrophy, run by Perfect Care Distribution at 14 sites in Romania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- Halova
- Type of treatment
- Medical device
- How many people
- 249 participants
- Where
- 14 sitesRomania
- Study dates
- 1 Mar 2022to 31 Jul 2022
- Phase
- Observational
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women, with atrophic vaginitis caused by estrogen hormone deficiency or vaginal dryness as a result of contraceptive treatment or other disorders.
Who may be able to join
- Adult women, aged between 18 and above, in pre-menopause or menopause;
- Adult women with atrophic vaginitis caused by estrogen hormone deficiency;
- Adult women who have vaginal dryness as a result of contraceptive treatment or other disorders;
- Subjects with a normal cervical cytology report, e.g. Negative for intraepithelial lesions or malignancy (NILM) or slightly changed to atypical squamous cells of undetermined significance (ASC-US) in the last 6 months;
- Subjects willing to provide signed informed consent for participation in clinical investigation.
Who cannot join
- Subjects with vulvar or cervical cancer.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Romania14 sites
Spitalul Clinic Dr. Ion Cantacuzino Bucharest
Bucharest
Med Life Humanitas Cluj-Napoca
Cluj-Napoca
Cabinet Medical - Dr. Saleh K. Majed
Craiova
Cabinet Medical - Dr. Surpanelu Oana
Iași
MediBlue
Iași
Clinica Natisan Pitesti
Piteşti
Cabinet Dr. Rădulescu G. Mihaela Elena
Râmnicu Vâlcea
Ramnicu Valcea
Râmnicu Vâlcea
Cabinet Ginecologic Dr. Popescu Sibiu
Sibiu
Clinica iMED
Sibiu
Pan Medical Sibiu
Sibiu
Bradmed SRL
Târgu Jiu
Clinica Medicala Dr. Cioata Ionel Trifon
Timișoara
Spitalul Judetean de Urgenta Tulcea
Tulcea
About this study
Official title: Real-world Evidence Study on the Performance and Safety of the Medical Device Halova Ovules in the Local Treatment of Vaginal Atrophy
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.
Read the detailed description
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).
- Conditions
- Vaginal Atrophy
- Being tested
- Halova
- Keywords
- Dyspareunia, Dysuria, Vaginal lubrication
- Medical subject headings
- Dyspareunia, Dysuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HalovaDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (2)
Clinical Performance
Evaluation by the Investigator of the disorder-related symptoms
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Mar 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perfect Care Distribution
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDX Research
- Responsible party
- Sponsor
- Investigators
- Ema Peta, Study director, Perfect Care Distribution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654610
- Sponsor's protocol ID
- HALOVRW/01/2022
- Status last verified
- Apr 2023
- First submitted
- 18 Nov 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evidence Study on the Performance and Safety of the Medical Device Halova Ovules in the Local Treatment of Vaginal Atrophy
- ClinicalTrials.gov ID
- NCT05654610
- Acronym / sponsor ID
- HALOVRW/01/2022
- Conditions
- Vaginal Atrophy
- Keywords
- Dyspareunia, Dysuria, Vaginal lubrication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Perfect Care DistributionIndustry (pharma, biotech, devices)
- Collaborators
- MDX Research
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 16 Dec 2022 (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.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women, with atrophic vaginitis caused by estrogen hormone deficiency or vaginal dryness as a result of contraceptive treatment or other disorders.
Key inclusion criteria (5 listed)
- Adult women, aged between 18 and above, in pre-menopause or menopause;
- Adult women with atrophic vaginitis caused by estrogen hormone deficiency;
- Adult women who have vaginal dryness as a result of contraceptive treatment or other disorders;
- Subjects with a normal cervical cytology report, e.g. Negative for intraepithelial lesions or malignancy (NILM) or slightly changed to atypical squamous cells of undetermined significance (ASC-US) in the last 6 months;
- Subjects willing to provide signed informed consent for participation in clinical investigation.
Key exclusion criteria (1 listed)
- Subjects with vulvar or cervical cancer.
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 |
|---|---|---|
| HalovaHalova 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. | Device | – |
Primary outcome
Rating and assessing of treatment-related Adverse Events
Time frame: 30 days
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
2 secondary outcomes
Clinical Performance
Time frame: 30 days
Patient Satisfaction
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
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F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
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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
Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
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.
Ema Peta study director
Perfect Care Distribution
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Atrophy, run by Perfect Care Distribution at 14 sites in Romania.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rating and assessing of treatment-related Adverse Events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.