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.
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%).
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Contacts