N76.1
Conditions
Interventions
Group 1: Lactal Gel administered as vaginal 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
Rolf Kullgren AB
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study. • Newly diagnosed BV episode, based on Amsel criteria (Amsel et al., 1983), i.e. presence of three of the following criteria: - increased homogeneous thin vaginal discharge - pH of the secretion >4.5 - amine odor when potassium hydroxide (KOH) 10% solution is added to a drop of vaginal secretions - presence of clue cells in wet preparations • Suffering from symptoms associated with BV, such as unusual vaginal discharge, odour and discomfort • Having access to a smartphone or a computer with an internet access and familiar with the use thereof • Readiness and ability to comply with study requirements, in particular: - to use IMD as recommended (in particular, for 7 consecutive days during the non-bleeding period of the menstrual cycle) - to avoid the use of any other interventional options for BV during the study (other than the IMD) - to avoid the use of any other intravaginal product (e.g. suppositories, gels, foams, lubricants, disinfectants, chemically based contraceptives etc.) during the study - to fill in the electronic Diary (eDiary) • Commitment to use contraception methods (with the exception of those defined in the previous inclusion criterion • Readiness not to participate in another clinical study during this study • Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at baseline visit (V1)
Exclusion criteria
Exclusion criteria: • Known allergy or hypersensitivity to the components of the IMD (self-reported). • Manifested or suspected Candida infection or any other vaginal mycosis. • Trichomoniasis. • Urogenital (dipstick testing), anal or rectal infection within the 3 weeks prior to (self-reported) / at baseline (V1). • History of recurrent genital herpes (self-reported). • Lesions/infections in the vaginal area. • Use of preparations that may influence the study outcome within the last 3 weeks prior to V1 and during the study (e.g. antibiotics, antimycotics, probiotics, corticosteroids etc.). • History in the past 6 months prior to V1 or presence of a sexually transmitted disease (self-reported). • History or presence of any other clinically significant known (self-reported) condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject. • Pregnancy, nursing or within first 3 months post-partum. • History of or current abuse of drugs, alcohol or medication. • Participation in another study during the last 30 days prior to V1. • Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of bacterial vaginosis (BV)-free subjects evaluating the Amsel criteria and the Amsel criteria score at the final visit (day 11 ± 2) . | — |
Secondary
| Measure | Time frame |
|---|---|
| • Improvement in each Amsel parameter from baseline to final visit (day 11 ± 2) • Patient evaluation for subjective discomfort, itching, and odor from baseline to final visit (day 11 ± 2) • Investigator and patient global evaluation of performance at final visit (day 11 ± 2) • Safety evaluation by collection of adverse events and by a global safety evaluation performed by patient and investigator from baseline to final visit (day 11 ± 2) • Assessment of patient satisfaction and usability of the tested device final visit (day 11 ± 2) | — |
Countries
Germany
Contacts
Public ContactSophie von Welser
Frauenarztpraxis Berlin Gemeinschaftspraxis
Outcome results
None listed