A sustained-release pessary containing oligomeric lactic acid for the treatment of bacterial vaginosis

Completed

• Conditions: Bacterial vaginosis; Urological and Genital Diseases

• Registration Number: ISRCTN86053784
• Lead Sponsor: accure AB (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

1. Females at least 18 years of age
2. Confirmed current diagnosis of bacterial vaginosis (determined at study screening) using Amsel's criteria
3. Subjects who are willing to refrain from the use of all other vaginal products throughout the study except for intrauterine device
4. Subjects must abstain from sexual intercourse or use condoms throughout the duration of the study
5. Women of child-bearing potential must have a negative urine pregnancy test result upon entry into the study
6. Subject is willing to answer questions mainly related to product acceptability but some that are related to sexual activity
7. Subjects who are able to give written informed consent and agree to follow-up on time

Exclusion Criteria

1. Women planning to become pregnant during the study period
2. Menstruating at the time of the diagnosis or anticipate the onset of menses during the course of the study
3. Post-menopausal women (definition: a woman experiencing 12 consecutive months of amenorrhea)
4. Received vaginal or oral antibiotics or pH restoring product(s) within two weeks prior to study enrolment
5. Subjects with yeast or trichomonas infection, diagnosed by microscopy
6. Suspicion of low genital tract infection, e.g. chlamydia or gonococcus infection
7. Subject with signs of vulvovaginal irriation where concomitant vaginal disease is suspected
8. Subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days
9. Subjects previously participated in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of patients with no bacterial vaginosis (BV) according to Amsel's criteria after 1 week in the once a week OMLA pessary treatment group compared with the control group.

Secondary Outcome Measures

Name	Time	Method
1. Frequency of patients with no BV after 1 week in the group treated twice a week with OMLA pessary (TW) vs the control group (CG), as well as in the once a week (OW) vs the twice a week group (TW) and the pooled OMLA pessary treatment groups (OW+TW) vs the control group<br>2. Frequency of patients after 1 week (day 8) positive for each of the four Amsel criteria in each treatment arm<br>3. Change in vaginal pH over time (day 4 and day 8) compared to baseline in each study arm<br>4. Patient treatment satisfaction after completed treatment in each treatment arm<br>5. Frequency of spontaneously reported adverse events during treatment in each treatment arm<br>6. Proportion of patients with any adverse findings upon vulvo-vaginal mucosa examination on day 8 compared to baseline