Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clever Instruments S.L. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether a formula of boric acid and probiotics for vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis in comparison to pharmacological reference controls (depending on the suspected diagnosis).
Multicentre, Open, Prospective, Randomized, Controlled. Women with suspected vaginal infection will be randomized and distributed into two groups (control or boric acid + probiotics). Follow-up will last for three months and consists in 3 visits and a telephone interview.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boric acid and probiotics | Experimental | Boric acid with L.gasseri and L.rhamnosus |
|
| Antibiotic/Antifungal | Active Comparator | Antibiotic: Clindamicine Antifungal: Clotrimazol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boric acid and probiotics | Device | Vaginal capsules administered once a day during 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Semi-quantitative scale where itching, erythema, edema, stinging and abnormal vaginal discharge are scored from 0 to 3: absent (0), mild (1), moderate (2), severe (3). Worse result is 3 (severe) | Baseline and at 2 weeks after treatment finalization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. | Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures. | Baseline and 2 weeks after treatment finalization |
| Number of Participants With Recurrent Infections |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juan A Tena, Dr. | Ginemed Sevilla | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ginemed Sevilla | Seville | Andalusia | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Boric Acid and Probiotics | Boric acid with L.gasseri and L.rhamnosus Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. |
| FG001 | Antibiotic/Antifungal | Antibiotic: Clindamicine Antifungal: Clotrimazol Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Boric Acid and Probiotics | Boric acid with L.gasseri and L.rhamnosus Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. |
| BG001 | Antibiotic/Antifungal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Semi-quantitative scale where itching, erythema, edema, stinging and abnormal vaginal discharge are scored from 0 to 3: absent (0), mild (1), moderate (2), severe (3). Worse result is 3 (severe) | Subscore Sobel Score values at baseline and visit 1 (from 0 to 3) | Posted | Mean | Standard Deviation | score on a scale | Baseline and at 2 weeks after treatment finalization |
|
From baseline to three months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Boric Acid and Probiotics | Boric acid with L.gasseri and L.rhamnosus Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roser De Castellar | Laboratorios Ordesa | +34 902105243 | Roser.DeCastellar@ordesa.es |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2016 | Aug 19, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D002981 | Clindamycin |
| D000935 | Antifungal Agents |
| D003022 | Clotrimazole |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Antibiotic (Clindamycin) | Drug | Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. |
|
|
| Antifungal (Clotrimazole) | Drug | Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days. |
|
|
Descriptive of the proportion of patients with vulvovaginitis recurrence |
| At 3 months after recruitment |
Antibiotic: Clindamicine Antifungal: Clotrimazol
Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.
Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Antibiotic: Clindamicine Antifungal: Clotrimazol
Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.
Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
| OG002 | Boric Acid and Probiotics Visit 1 | Boric acid with L.gasseri and L.rhamnosus Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. |
| OG003 | Antibiotic/Antifungal Visit 1 | Antibiotic: Clindamicine Antifungal: Clotrimazol Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days. |
|
|
| Secondary | Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. | Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures. | Posted | Mean | Standard Deviation | Count of Organism/counting chamber | Baseline and 2 weeks after treatment finalization |
|
|
|
| Secondary | Number of Participants With Recurrent Infections | Descriptive of the proportion of patients with vulvovaginitis recurrence | Posted | Count of Participants | Participants | At 3 months after recruitment |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Antibiotic/Antifungal | Antibiotic: Clindamicine Antifungal: Clotrimazol Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days. | 0 | 24 | 0 | 24 | 0 | 24 |
Not provided
Not provided
| D014627 |
| Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D008034 |
| Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D007093 | Imidazoles |
| D001393 | Azoles |