Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 11, 2019

Primary Completion Date

November 22, 2019

Study Completion Date

November 22, 2019

Conditions
Vaginal Disease
Interventions
DEVICE

Ainara

Each administration kit (subject kit) for patients of Ainara® will contain a box with 1 tube with 30 g gel, 1 cannula and 1 plunger. The gel quantity is enough for one subject over the course of the study (1 g at each administration).

DEVICE

HyaloGin

"Active Comparator: HyaloGin Each administration kit (subject kit) for patients allocated to HyaloGyn® group will contain a box with: 1 tube with 30g gel and 10 single-use applicators consisting of a piston and one opaque plastic plunger.~The gel quantity is enough for one subject (3g application every three days over the course of the study)."

Trial Locations (1)

Unknown

Fizio Center, Timișoara

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Opera CRO, a TIGERMED Group Company

OTHER

lead

Italfarmaco

INDUSTRY