An interventional study of Halova vaginal ovules and Placebo vaginal ovules in Vaginal Dryness and Genitourinary Symptoms, sponsored by Perfect Care Distribution. Completed at 1 site in Romania. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Perfect Care Distribution · Not applicable, Interventional, and Treatment
This post-market clinical study evaluated whether Halova vaginal ovules improve vaginal dryness and other genitourinary symptoms in premenopausal women and assessed their safety.
The main questions were:
Participants:
This post-market, randomized, double-blind, single-center, placebo-controlled clinical study was designed to evaluate the efficacy and safety of Halova vaginal ovules in premenopausal women with vaginal dryness and other genitourinary symptoms.
Participants were randomized in a 2:1 ratio to receive Halova or placebo. The assigned vaginal ovules were administered once daily for 10 consecutive days per month, during the intermenstrual period, for 3 consecutive months.
Clinical efficacy was assessed using the Most Bothersome Symptom (MBS) score and the Vaginal Health Index (VHI), including vaginal pH and other components of vaginal health. Sexual function was assessed using the Female Sexual Function Index (FSFI). Safety was evaluated through monitoring of adverse events and treatment tolerability.
Assessments were performed at baseline and at week 12, with follow-up assessment at week 24 to evaluate the persistence of treatment effects. Telephone monitoring was also conducted during the intervention period to assess adherence, tolerability, effectiveness, satisfaction, and adverse events.
The study additionally included an educational component addressing premenopause and menopause. Participants completed a structured questionnaire assessing knowledge and attitudes at baseline, before the educational intervention, and again at week 12 after counseling and use of the educational materials.
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's enrollment of 150 is above the median of 63 across 126 interventional 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.
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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.
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.
The human immunodeficiency virus, which weakens the immune system.
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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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One Halova vaginal ovule was administered intravaginally once daily for 10 days per month for three months, during the intermenstrual period.
Device: Halova vaginal ovules
One placebo vaginal ovule was administered intravaginally once daily for 10 days per month for three months, during the intermenstrual period.
Device: Placebo vaginal ovules
Halova is a vaginal medical device formulated as ovules containing sodium hyaluronate (5 mg per ovule) and xylitol (3 mg per ovule), together with semi-synthetic glycerides, lanolin, Aloe vera oil extract, Calendula officinalis extract, colloidal silicon dioxide, and vitamin E. One ovule was administered intravaginally once daily, preferably in the evening, for 10 consecutive days per month, during the intermenstrual period, for three consecutive months.
Placebo vaginal ovules consisted of the same lipid-based excipient matrix as the investigational product, without sodium hyaluronate and xylitol. The placebo was designed to maintain blinding and was administered according to the same schedule as the active intervention.
Change From Baseline in Most Bothersome Symptom (MBS) Score at Week 12
At baseline, each participant identified the genitourinary symptom causing the greatest discomfort (Most Bothersome Symptom, MBS), including vaginal dryness, dyspareunia, or urinary symptoms. The same symptom was reassessed at Week 12 using an 11-point numerical rating scale from 0 (symptom absent) to 10 (maximum severity). Improvement was calculated as the baseline score minus the Week 12 score, with positive values indicating reduced symptom severity.
Time frame: Baseline and Week 12
Change From Baseline in Vaginal Health Index (VHI) Total Score at Week 12
Vaginal health was assessed using a study-adapted version of the Vaginal Health Index (VHI), as defined in the study-specific standardized clinical assessment guide. Five parameters were evaluated: vaginal elasticity, moisture, vaginal pH category, epithelial integrity, and inflammation. Each parameter was scored from 0 (severely impaired) to 5 (normal). The total score was calculated as the sum of the five component scores and ranged from 0 to 25, with higher scores indicating better vaginal health. Change was calculated as the Week 12 total score minus the baseline total score, with positive values indicating improvement.
Time frame: Baseline and Week 12
Change From Baseline in Vaginal Health Index pH Component Score at Week 12
Vaginal pH was evaluated using the ordinal pH component of the Vaginal Health Index (VHI), based on predefined pH categories. Component scores ranged from 0 (pH greater than 6.5) to 5 (pH of 4.5 or lower), with higher scores indicating a more favorable vaginal pH category. The recorded outcome was the categorical component score rather than the exact numerical pH value. Change was calculated as the Week 12 component score minus the baseline score, with positive values indicating improvement.
Time frame: Baseline and Week 12
Change From Baseline in Female Sexual Function Index (FSFI) Total Score at Week 12
Female sexual function was assessed using the 19-item Female Sexual Function Index (FSFI), covering six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores range from 2 to 36, with higher scores indicating better sexual function. The outcome was calculated as the Week 12 total score minus the baseline score, with positive values indicating improvement. The primary FSFI analysis included participants with calculable total scores; analysis restricted to participants sexually active at baseline was supplementary.
Time frame: Baseline and Week 12
Change From Baseline in Most Bothersome Symptom (MBS) Score at Week 24
The Most Bothersome Symptom identified at baseline was reassessed at Week 24 using the same 0-10 numerical rating scale. Improvement was calculated as the baseline score minus the Week 24 score, with positive values indicating reduced symptom severity. This assessment evaluated the persistence of symptom improvement after treatment discontinuation.
Time frame: Baseline and Week 24
Change From Baseline in Vaginal Health Index Score at Week 24
The Vaginal Health Index total score (0-25), calculated according to the study-specific standardized scoring guide, was reassessed at Week 24. Change was calculated as the Week 24 total score minus the baseline score, with positive values indicating improved vaginal health. This assessment evaluated the persistence of treatment effects.
Time frame: Baseline and Week 24
Change From Baseline in Vaginal Health Index pH Component Score at Week 24
The ordinal vaginal pH component score of the VHI (0-5) was reassessed at Week 24 using the same predefined categories. Change was calculated as the Week 24 component score minus the baseline score, with positive values indicating improvement in the vaginal pH category.
Time frame: Baseline and Week 24
Change From Baseline in Female Sexual Function Index (FSFI) Total Score at Week 24
The Female Sexual Function Index total score (2-36) was reassessed at Week 24. Change was calculated as the Week 24 total score minus the baseline score, with positive values indicating improvement in sexual function. This assessment evaluated the persistence of treatment-related changes.
Time frame: Baseline and Week 24
Number of Participants With Adverse Events During the Study
Safety was assessed by recording adverse events reported by participants or identified during scheduled clinical assessments and telephone follow-up. The outcome was the number of participants experiencing at least one adverse event during the study. Events were documented according to severity, suspected relationship to the assigned intervention, clinical management, and outcome.
Time frame: From baseline through Week 24
Item-Level Responses to a Menopause-Related Knowledge, Attitudes, and Behaviors Questionnaire
Participants completed a study-specific questionnaire at baseline, before individualized educational counseling and receipt of written educational materials, and again at Week 12. The questionnaire assessed recognition of menopause-related symptoms, associated health risks, and management options, as well as attitudes, information-seeking behaviors, and willingness to seek professional advice or accept local treatment. For each questionnaire item, outcomes were the number and percentage of participants selecting each response option at baseline and Week 12, and the change in these percentages between assessments. For questions allowing multiple responses, each response option was evaluated separately. No composite scoring algorithm was prespecified in the study protocol.
Time frame: Baseline and Week 12
Self-Reported Adherence to the Assigned Intervention at Weeks 4 and 8
Treatment adherence was assessed through structured telephone follow-up at Weeks 4 and 8. Participants reported whether they had used the assigned vaginal ovules according to the prescribed administration schedule (Yes/No). The outcome was the number and percentage of participants reporting adherence at each assessment.
Time frame: Weeks 4 and 8
Plan to share: No — Individual participant data will not be made publicly available due to participant confidentiality and data protection considerations. Study results will be reported in aggregate form through peer-reviewed scientific publications.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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