EFFICACY AND SAFETY OF OVA AND LAVAGE MEDICAL DEVICES IN THE TREATMENT OF NON-SPECIFIC VULVOVAGINITIS

NACompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

July 17, 2020

Primary Completion Date

December 15, 2021

Study Completion Date

August 13, 2022

Conditions
Vaginosis, Bacterial
Interventions
DEVICE

Logusgyn ovules

"LOGUSGYN ovules is a CE certified Class I medical device, according to MD Directive 93/42 / EEC as amended by Directive 2007/47 / EC, manufactured by ERBOZETA S.p.a. designed for its intended use. It consists of a vaginal ova dressing for topical use containing tindalised cultures, Guar fibre, Lactic acid and Calendula.~It is supplied in a container with 10 vaginal ova. For this study, LOGUSGYN/CANDIDEP ova/wash will be packaged according to good manufacturing practice and local regulatory requirements and will be labelled in accordance with local regulatory requirements and according to GMP Annex 13."

DEVICE

Logusgyn Lavander

"LOGUSGYN lavage is a CE certified class I medical device, according to MD Directive 93/42 / EEC as amended by Directive 2007/47 / EC, manufactured by ERBOZETA S.p.a. designed for its intended use. It consists of a gynaecological lavage dressing containing Chlorhexidine 0.2% and tindalised ferments, lactic acid, bisabolol.~It is supplied in a container with 5 vaginal douches.~For this study, LOGUSGYN/CANDIDEP ova/wash will be packaged according to good manufacturing practice and local regulatory requirements and will be labelled in accordance with local regulatory requirements and according to GMP Annex 13."

OTHER

Placebo

Sterile saline solution

Trial Locations (1)

81031

Ospedale San Giovanni Moscati, Aversa

All Listed Sponsors
collaborator

Erbozeta S.p.A

UNKNOWN

lead

Ospedale del Mare

OTHER

NCT05649735 - EFFICACY AND SAFETY OF OVA AND LAVAGE MEDICAL DEVICES IN THE TREATMENT OF NON-SPECIFIC VULVOVAGINITIS | Biotech Hunter | Biotech Hunter