Evaluation of Viscosity of a Vaginal Moisturizer

NCT03782961 | Unknown Phase 4

• 1 other identifier: FE4 - HIDRAFEMME - PA - 010
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Vaginal Dryness; Menopausal Women

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Stand up

EXPERIMENTAL

After application of the product (sodium lactate and combination of polymers) will remain standing for 30 minutes

Device: sodium lactate and combination of polymers

Lying down

EXPERIMENTAL

After application of the product (sodium lactate and combination of polymers) remained lying down with the legs stretched for 30 minutes;

Device: sodium lactate and combination of polymers

Interventions

sodium lactate and combination of polymers DEVICE

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

Lying down; Stand up

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Farmoquimica S.A.: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: January 14, 2019
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: December 21, 2018

Record last verified: 2018-12