NCT04342559: PRV01

Acceptability, Under Use in Real Conditions Of Two Vaginal Moistures Indicated for Women With Vaginal Drying

Completed NA Last updated 13 April 2020

What this trial tests

NA trial testing Belamy (vaginal moisturizer) in Vaginal Dryness in 74 participants. Completed in 6 April 2020.

Timeline

6 April 2020

Primary endpoint
6 April 2020

6 April 2020

Quick facts

Lead sponsor	Libbs Farmacêutica LTDA
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	74
Start date	6 April 2020
Primary completion	6 April 2020
Estimated completion	6 April 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Belamy (vaginal moisturizer)

Conditions studied

• Vaginal Dryness — all drugs for Vaginal Dryness →

Sponsor

Libbs Farmacêutica LTDA

Who can join

Eligibility, female only, with Vaginal Dryness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The studies carried out to evaluate the safety and efficacy of products aimed at the intimate area of women aim to confirm the absence of risk associated with its use, identify possible feelings of discomfort and / or clinical signs resulting from the use of the product and evaluate the benefits provided by the use of the product such as, gynecologically tested, clinically tested, hydration for 72 hours, hydration, does not drip or drip little, feeling of natural hydration, control of natural vaginal odor, preserves vaginal pH, does not promote irritation, use vaginal topic, feeling of comfort, relief from dryness, easy use of the applicator, the applicator does not cause discomfort during application, preferably use at night, does not change the vaginal flora, reduces pain and discomfort during or shortly after sexual intercourse, does not promote discomfort during or shortly after intercourse, reduction of vaginal bleeding during or right after sexual intercourse, if there is a small amount left in the applicator, the treatment is not compromised.

The research will be carried out with two new products for use in the internal intimate region in up to 74 research participants (up to 37 participants per product - each group of 37 will use one of the products), which meet the required inclusion and exclusion criteria. At the end of the treatment, the analysis must contain a minimum number of 30 participants per product. Participants will use the test products for 22 (+ 2) days and will be evaluated and monitored throughout the study by a gynecologist to verify the effectiveness of the products and possible adverse events. In addition, a profile questionnaire will be applied at the beginning of the study (T0 - day 1) and at the end of the study, the perceived efficacy questionnaire (T22), to assess signs and symptoms of the efficacy and safety of the product used.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.