Evaluation of Viscosity of a Vaginal Moisturizer

Vaginal Dryness Clinical Trial

Official title:

Evaluation of Perceived Effectiveness to Evaluate Viscosity of a Vaginal Moisturizer in Menopaused Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03782961
• Other study ID #: FE4 - HIDRAFEMME - PA - 010
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 14, 2019
• Est. completion date: January 25, 2019

Study information

• Verified date: December 2018
• Source: Farmoquimica S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women

Description:

A unicentric, blind, non-comparative clinical study to prove the perceived efficacy of the research product.

It will be necessary 33 female research participants, aged between 45 and 70 years menopause with complaint of vaginal dryness.

The participant will remain in the study for one day, making use of the research product in the Research Center.

Participants will be divided into 2 groups so that each group observes the viscosity (flow) of the test product in a different anatomical position (lying down and standing) immediately after application of the product, after 15 and 30 minutes.

Participants will respond to a subjective assessment using a standardized questionnaire to capture possible feelings of discomfort during the study.

A gynecologist will be available to monitor the participants throughout the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

• Menopausal participants for at least 6 months;

• Participants with complaints of vaginal dryness;

• Skin integrity in the region of product analysis;

• Agreement to comply the procedures of the trial and attend the clinic on the days and times determined for applications and / or evaluations;

• Understanding, agreement and signing of the Informed Consent Term.

Exclusion Criteria:

• Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks prior to selection;

• Pathologies and / or active skin lesions (local and / or disseminated) in the evaluation area;

• Immunosuppression by drugs or active diseases;

• Decompensated endocrinopathies;

• Relevant clinical history or current evidence of alcohol or other drug abuse;

• known history or suspected intolerance to products of the same category;

• Intense sun exposure up to 15 days before evaluation;

• Gynecological treatment up to 4 weeks before evaluation;

• Other conditions considered by the researcher to be reasonable for disqualification of study participation.

Related Conditions & MeSH terms

• Menopausal Women
• Vaginal Dryness

Intervention

Device:
• sodium lactate and combination of polymers
sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Farmoquimica S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate subjectively the perceived viscosity change	Perceived viscosity change of the research product from the point of view of the target public under normal conditions of use through a questionnaire	Immediately after application, 15 and 30 minutes after application