Prophylaxis of bacterial vaginosis Infections and Infestations
Conditions
Interventions
Women, cured (confirmed by the absence of 3 out of 4 Amsel criteria) from an episode of BV by an antibiotic treatment course of either metronidazole or clindamycin, were randomly assigned to receive v
Sponsors
Polichem SA (Switzerland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age = 18 years and < 50 years 2. Medical history positive for recurrent BV episodes (= 2 by years) 3. Regular menses 4. Diagnosis of BV (= 3 out of 4 Amsel criteria) at enrolment 5. Cure from the current BV episode (= 3 out of 4 Amsel criteria) with either metronidazole or clindamycin, according to the local therapeutic protocols 6. Written informed consent 7. Co-operative and reliable women
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to ascorbic acid or to any of the ingredients 2. Metrorrhagia, polymenorrhea, amenorrea 3. Current or previous infections due to Neisseria gonorrheae, Treponema palidum, Herpes genitalis during the last 2 weeks before enrolment 4. Current or previous infections due to Candida spp. or to Trichomonas vaginalis during the last 2 weeks before enrolment 5. Concomitant treatment with local antibiotics, such as metronidazole and clindamycin, during the study prophylaxis 6. Concomitant use of local acidifying agents, disinfectants, Lactobacillus preparations or vaginal douching during the last 2 weeks before enrolment and during the study period 7. Immunodepression, including HIV positive patients 8. Concomitant neoplastic diseases under treatment 9. Ongoing pregnancy of women willing to be pregnant during the study period 10. Participation to clinical trials with investigational drug / devices during the last 3 months before enrolment 11. History of alcohol and drug abuse 12. Subjects likely to be not compliant or uncooperative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the first BV relapse (according to Amsel criteria) in the 2 groups during the period of prophylaxis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Vaginal signs and symptoms (Erythema, Oedema, Fissures, Odour, Itching, Burning, Dysuria, Discharge) assessed by means of a four-point scale: 1=absent; 2=mild; 3=moderate; 4=severe 2. Measurement of vaginal pH 3. Investigator?s and subject?s judgement on product acceptability and tolerability assessed by means of a four-point scale: 1= very good, 2= good, 3=fair, 4= poor, 5= very poor 4. Assessment of adverse event (AEs) occurring at any time during the study | — |
Countries
Germany, Italy, Netherlands, Portugal, Russian Federation, Ukraine
Outcome results
None listed