Status:

UNKNOWN

Evaluation of Viscosity of a Vaginal Moisturizer

Lead Sponsor:

Farmoquimica S.A.

Conditions:

Vaginal Dryness

Menopausal Women

Eligibility:

FEMALE

45-70 years

Phase:

PHASE4

Brief Summary

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

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 menopau...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 14 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 25 2019

Estimated Enrollment :

33 Patients enrolled

Trial Details

Trial ID

NCT03782961

Start Date

January 14 2019

End Date

January 25 2019

Last Update

December 21 2018

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