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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02860845
Other study ID # DOBO-01-16
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 12, 2016
Est. completion date November 30, 2017

Study information

Verified date November 2019
Source Laboratorios Ordesa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a formula of boric acid and probiotics for vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis in comparison to pharmacological reference controls (depending on the suspected diagnosis).


Description:

Multicentre, Open, Prospective, Randomized, Controlled. Women with suspected vaginal infection will be randomized and distributed into two groups (control or boric acid + probiotics). Follow-up will last for three months and consists in 3 visits and a telephone interview.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date November 30, 2017
Est. primary completion date October 16, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age over 18 years and agreement to participate by signing the consent form.

- Women with clinical manifestations of acute infectious vulvovaginitis (burning, pruritus, erythema, oedema, and abnormal vaginal discharge).

Exclusion Criteria:

- Clinical findings compatible with Chlamydia trachomatis, Neisseria gonorrhoeae or Trichomonas vaginalis infection.

- Use of anti-fungal, antibiotic or probiotic medication within last 2 weeks prior to the study.

- Patients receiving other treatment (drug, probiotics or vitamin supplements) that can significantly interfere with study evaluations during the 3 months of follow-up.

- Pregnant or high risk for pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Boric acid and probiotics
Vaginal capsules administered once a day during 7 days.
Drug:
Antibiotic (Clindamycin)
Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.
Antifungal (Clotrimazole)
Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.

Locations

Country Name City State
Spain Ginemed Sevilla Sevilla Andalucía

Sponsors (2)

Lead Sponsor Collaborator
Laboratorios Ordesa Clever Instruments S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. Semi-quantitative scale where itching, erythema, edema, stinging and abnormal vaginal discharge are scored from 0 to 3: absent (0), mild (1), moderate (2), severe (3). Worse result is 3 (severe) Baseline and at 2 weeks after treatment finalization
Secondary Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures. Baseline and 2 weeks after treatment finalization
Secondary Number of Participants With Recurrent Infections Descriptive of the proportion of patients with vulvovaginitis recurrence At 3 months after recruitment
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