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Evaluation of Viscosity of a Vaginal Moisturizer

Sponsor
Farmoquimica S.A. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03782961
Collaborator
(none)
33
Enrollment
2
Arms
11
Anticipated Duration (Days)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: sodium lactate and combination of polymers
 Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Evaluation of Perceived Effectiveness to Evaluate Viscosity of a Vaginal Moisturizer in Menopaused Women
Anticipated Study Start Date :
Jan 14, 2019
Anticipated Primary Completion Date :
Jan 25, 2019
Anticipated Study Completion Date :
Jan 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stand up

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

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

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

Outcome Measures

Primary Outcome Measures

  1. To evaluate subjectively the perceived viscosity change [Immediately after application, 15 and 30 minutes after application]

    Perceived viscosity change of the research product from the point of view of the target public under normal conditions of use through a questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Farmoquimica S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Farmoquimica S.A.
ClinicalTrials.gov Identifier:
NCT03782961
Other Study ID Numbers:
  • FE4 - HIDRAFEMME - PA - 010
First Posted:
Dec 20, 2018
Last Update Posted:
Dec 21, 2018
Last Verified:
Dec 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 21, 2018