Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections

Recruiting N/A Interventional Study
Bacterial Vaginosis Vaginal Candidiasis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Karo Pharma AB · Industry
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About This Trial
The goal of this clinical trial is to assess the safety and efficacy of Multi-Gyn Femitotal to treat and prevent women suffering from bacterial vaginosis and vulvo vaginal candidiasis. 40 subjects with itching symptoms of VVC and 49 subjects with BV as confirmed using Amsel criteria will be included and will use the device for 7 days (treatment phase). If the VVC symptoms and BV are considered as …
Trial Locations
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Eligibility Criteria
Inclusion Criteria 1. Age ≥ 18 years old. 2. Women suffering from VVC or BV at the time of inclusion: 3. For VVC: Subject with at least itching score \> 2 and crumbly white discharge. 4. For BV: Subject with at least 3 out of 4 Amsel criteria positive, with at least presence of clue cells (\>20%). …
Contacts

Diana Zeneli, MD

0031614706949

diana.zeneli@karo.com

CONTACT

Johan Ohlson

johan.ohlson@karo.com

CONTACT