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Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis

NCT07241871 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-21

No results posted yet for this study

Summary

The aim of this study is to find out how well the medical device Lactal Gel works and how safe it is. The product will be used to treat bacterial vaginosis in a group of fifty women aged 18 years or older.

All participants will receive the one-week treatment as part of their usual medical care.

Each participant will have two visits: one at the beginning of the study (the initial assessment) and another at day 11 (the final visit).

During these visits, the doctor will:

* Perform a normal medical check-up
* Diagnose bacterial vaginosis using the Amsel criteria (which include checking vaginal pH, appearance of discharge, odor, and microscopic examination)
* Ask about symptoms such as odor, discomfort, and itching
* Evaluate, together with the patient, how well the treatment is working
* Assess the patient's satisfaction and how easy the product is to use
* Check that the treatment is safe and well tolerated The results of this study will help doctors choose the most effective and safest treatment for bacterial vaginosis.

Conditions

  • Bacterial Vaginosis

Interventions

DEVICE

Lactal Gel (Class IIa medical device)

One tube of Lactal Gel is daily administered for 7 consecutive days, before bedtime (not during menstrual bleeding period).

Sponsors & Collaborators

  • Analyze & Realize

    collaborator NETWORK

  • Rolf Kullgren AB

    lead INDUSTRY

Principal Investigators

  • Christiane Bünemann-Buschmann, Dr. med · Frauenarztpraxis Berlin Gemeinschaftspraxis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-29
Primary Completion
2023-03-29
Completion
2023-03-29

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07241871 on ClinicalTrials.gov