Halova Vaginal Ovules Versus Placebo for Genitourinary Symptoms in Premenopausal Women
NCT07927088, Not applicable, Completed, Perfect Care Distribution
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Halova Vaginal Ovules Versus Placebo for Genitourinary Symptoms in Premenopausal Women | ClinicalTrials.gov |
| NCT number | NCT07927088 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 150 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Perfect Care Distribution | ClinicalTrials.gov |
| Conditions | Vaginal Dryness, Genitourinary Symptoms | ClinicalTrials.gov |
| Interventions | Halova vaginal ovules, Placebo vaginal ovules | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline in Most Bothersome Symptom (MBS) Score at Week 12 | Baseline and 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. | ClinicalTrials.gov |
| Primary | Change From Baseline in Vaginal Health Index (VHI) Total Score at Week 12 | Baseline and 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. | ClinicalTrials.gov |
| Primary | Change From Baseline in Vaginal Health Index pH Component Score at Week 12 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Female Sexual Function Index (FSFI) Total Score at Week 12 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Most Bothersome Symptom (MBS) Score at Week 24 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Vaginal Health Index Score at Week 24 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Vaginal Health Index pH Component Score at Week 24 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Female Sexual Function Index (FSFI) Total Score at Week 24 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Number of Participants With Adverse Events During the Study | From baseline through Week 24 | 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. | ClinicalTrials.gov |
| Secondary | Item-Level Responses to a Menopause-Related Knowledge, Attitudes, and Behaviors Questionnaire | Baseline and Week 12 | 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. | ClinicalTrials.gov |
| Secondary | Self-Reported Adherence to the Assigned Intervention at Weeks 4 and 8 | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)