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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001120-19 | EudraCT Number |
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In this first-in-human volunteer phase I clinical trial, a vaginal ring that slowly releases lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy volunteering women and left in place for 7 days. The primary objective of this phase I study is to assess the safety and the tolerability of this new intravaginal delivery system.
The eventual goal of this and related studies is to develop a vaginal ring that reduces recurrences in women suffering from bacterial vaginosis, which is the commonest form of vaginal infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Ring | Experimental | A vaginal ring that slowly releases lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy volunteering women and left in place for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal ring releasing lactic acid (racemic mixture) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy | 1 hour after insertion | |
| Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy | 2 hours after insertion | |
| Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy | 4 hours after insertion | |
| Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy | 8 hours after insertion | |
| Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy | 24 hours after insertion | |
| Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy | 7 days after insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of vaginal pH | each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Verstraelen, Prof. dr. | University & University Hospital Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics & Gynaecology, Ghent University Hospital P4 | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27093291 | Derived | Verstraelen H, Vervaet C, Remon JP. Rationale and Safety Assessment of a Novel Intravaginal Drug-Delivery System with Sustained DL-Lactic Acid Release, Intended for Long-Term Protection of the Vaginal Microbiome. PLoS One. 2016 Apr 19;11(4):e0153441. doi: 10.1371/journal.pone.0153441. eCollection 2016. |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |