Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05012852
Status:
UNKNOWN
Last Update Posted:
2021-09-23
First Post:
2021-08-04
Brief Title:
Evaluation of VagiVitalAC for Treatment of Candida Vulvovaginitis
Sponsor:
PepTonic Medical AB
Organization:
PepTonic Medical AB
Study Overview
Official Title:
A Two-part Study Consisting of a Pilot Part Followed by a Randomized Parallel Group Part Comparing Topically Applied Novel Gel Containing Lactic Acid With no Treatment on Women With Candida Vulvovaginitis
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Candidiasis is an infection caused by a yeast a type of fungus called Candida Candidiasis in the vagina is commonly called a vaginal yeast infection Another names for this infection is vaginal candidiasis The symptoms of vaginal candidiasis include Vaginal itching or soreness Pain during sexual intercourse Pain or discomfort when urinating and Abnormal vaginal discharge VagiVitalAC is a modified version of the existing gel VagiVital formulated to act as a treatment for fungal infections
This clinical investigation is a two-part study consisting of a pilot part followed by a randomized part The aim of the pilot part is to evaluate if VagiVitalAC is able to cure the vulvovaginal candidiasis in at least 70 of the patients after 7 days treatment If the proportion of cured patients is at least 70 the next part the randomized part will be performed In the randomized part the treatment efficacy and safety of VagiVitalAC on candida vulvovaginitis will be evaluated by comparing a treatment group with a control group receiving no treatment
This clinical investigation is a two-part study consisting of a pilot part followed by a randomized part The aim of the pilot part is to evaluate if VagiVitalAC is able to cure the vulvovaginal candidiasis in at least 70 of the patients after 7 days treatment If the proportion of cured patients is at least 70 the next part the randomized part will be performed In the randomized part the treatment efficacy and safety of VagiVitalAC on candida vulvovaginitis will be evaluated by comparing a treatment group with a control group receiving no treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIV-21-06-037087 | REGISTRY | EUDAMED | None |