Halova Vaginal Ovules Versus Vaginal Estriol for Genitourinary Symptoms in Postmenopausal Women
NCT07932990, 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 Vaginal Estriol for Genitourinary Symptoms in Postmenopausal Women | ClinicalTrials.gov |
| NCT number | NCT07932990 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 252 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Perfect Care Distribution | ClinicalTrials.gov |
| Conditions | Genitourinary Syndrome of Menopause (GSM), Vaginal Dryness, Vulvo Vaginal Atrophy (VVA) | ClinicalTrials.gov |
| Interventions | Halova vaginal ovules, Estriol 0.5 mg vaginal ovules, Menopause-related education and counseling | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 17
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, such as 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 Study-Adapted 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 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 pH Component Score of the Study-Adapted VHI at Week 12 | Baseline and Week 12 | Vaginal pH was summarized using the ordinal pH component of the study-adapted VHI. Scores ranged from 0 to 5: 5 for pH 4.5 or lower; 4 for pH above 4.5 to 5.0; 3 for pH above 5.0 to 5.5; 2 for pH above 5.5 to 6.0; 1 for pH above 6.0 to 6.5; and 0 for pH above 6.5. Higher scores indicated a more favorable vaginal pH category. Change was calculated as the Week 12 component score minus the baseline score, with positive values indicating improvement. The analyzed outcome was the component score rather than the raw numerical pH value. | 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 desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores ranged from 2 to 36, with higher scores indicating better sexual function. Change was calculated as the Week 12 total score minus the baseline total score, with positive values indicating improvement. The main 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 | At baseline, each participant identified the genitourinary symptom causing the greatest discomfort, such as vaginal dryness, dyspareunia, or urinary symptoms. The same symptom was reassessed at Week 24 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 24 score, with positive values indicating reduced symptom severity. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Study-Adapted Vaginal Health Index (VHI) Total Score at Week 24 | Baseline and Week 24 | 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 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 24 total score minus the baseline total score, with positive values indicating improvement. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Vaginal pH Component Score of the Study-Adapted VHI at Week 24 | Baseline and Week 24 | Vaginal pH was summarized using the ordinal pH component of the study-adapted VHI. Scores ranged from 0 to 5: 5 for pH 4.5 or lower; 4 for pH above 4.5 to 5.0; 3 for pH above 5.0 to 5.5; 2 for pH above 5.5 to 6.0; 1 for pH above 6.0 to 6.5; and 0 for pH above 6.5. Higher scores indicated a more favorable vaginal pH category. Change was calculated as the Week 24 component score minus the baseline score, with positive values indicating improvement. The analyzed outcome was the component score rather than the raw numerical pH value. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Female Sexual Function Index (FSFI) Total Score at Week 24 | Baseline and Week 24 | Female sexual function was assessed using the 19-item Female Sexual Function Index (FSFI), covering desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores ranged from 2 to 36, with higher scores indicating better sexual function. Change was calculated as the Week 24 total score minus the baseline total score, with positive values indicating improvement. The main 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 Endometrial Thickness at Week 12 | Baseline and Week 12 | Endometrial thickness was measured in millimeters by transvaginal ultrasound. Change was calculated as the Week 12 measurement minus the baseline measurement; positive values indicated increased thickness. The quantitative analysis included participants with measurable values greater than zero at both assessments. Zero values treated as not applicable in the context of an absent uterus were excluded from this continuous analysis. Clinically relevant individual findings were also documented in the safety record. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Endometrial Thickness at Week 24 | Baseline and Week 24 | Endometrial thickness was measured in millimeters by transvaginal ultrasound. Change was calculated as the Week 24 measurement minus the baseline measurement; positive values indicated increased thickness. The quantitative analysis included participants with measurable values greater than zero at both assessments. Zero values treated as not applicable in the context of an absent uterus were excluded from this continuous analysis. Clinically relevant individual findings were also documented in the safety record. | ClinicalTrials.gov |
| Secondary | Number of Participants With Adverse Events During the Study | From baseline through Week 24 | Safety was assessed by documenting adverse events reported by participants or identified during clinical assessments and telephone follow-up, regardless of the suspected relationship to treatment. The outcome was the number and percentage of treated participants experiencing at least one adverse event. Events were characterized by seriousness, severity, suspected relationship to the assigned intervention, action taken, and outcome. Safety summaries included all treated participants, with separate reporting for the randomized subset when appropriate. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Item-Level Responses to a Menopause-Related Knowledge, Attitudes, and Behaviors Questionnaire at Week 12. | 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 perceptions and behaviors related to menopause. For each 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 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 Week 2 | Week 2 | Adherence to the prescribed administration schedule was assessed from participant reports and recorded in the study case report form. The outcome was the number and percentage of participants documented as adherent at Week 2. The denominator was the number of participants with available adherence data at that assessment | ClinicalTrials.gov |
| Secondary | Self-Reported Adherence to the Assigned Intervention at Week 4 | Week 4 | Adherence to the prescribed administration schedule was assessed from participant reports and recorded in the study case report form. The outcome was the number and percentage of participants documented as adherent at Week 4. The denominator was the number of participants with available adherence data at that assessment. | ClinicalTrials.gov |
| Secondary | Self-Reported Adherence to the Assigned Intervention at Week 8 | Week 8 | Adherence to the prescribed administration schedule was assessed from participant reports and recorded in the study case report form. The outcome was the number and percentage of participants documented as adherent at Week 8. The denominator was the number of participants with available adherence data at that assessment | ClinicalTrials.gov |
| Secondary | Self-Reported Adherence to the Assigned Intervention at Week 12 | Week 12 | Adherence to the prescribed administration schedule was assessed from participant reports and recorded in the study case report form. The outcome was the number and percentage of participants documented as adherent at Week 12. The denominator was the number of participants with available adherence data at that assessment. | ClinicalTrials.gov |
| Other | Participant-Reported Treatment Satisfaction at Week 12 | Week 12 | Participants reported overall treatment satisfaction using five response categories: very satisfied, satisfied, no opinion, dissatisfied, or very dissatisfied. The outcome was the number and percentage of evaluable participants in each response category at the end-of-treatment assessment. Positive satisfaction was summarized as the number and percentage selecting very satisfied or satisfied. | 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)