Gynecological assessment of HG22

Not Applicable

• Conditions: oninflammatory disorder of vagina, unspecified

• Registration Number: RBR-9tf7y5
• Lead Sponsor: INFAN - Indústria Química e Farmacêutica Nacional

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-03
• Last Update Posted: 29 May 2023
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Female participants; Participants complaining of vaginal dryness and active sex life; Age between 18 to 65 years; Examination of gynecological inspection must be normal; Agreement to obey the trial procedures and attend the clinic on the days and times determined for medical evaluations; Understand, consent and sign the Free and Informed Consent Form (ICF).

Exclusion Criteria

Pregnancy or pregnancy risk; Lactation; Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study); Active skin pathologies (local and / or disseminated) in the evaluation area; Pathologies that cause suppression of immunity, such as diabetes, HIV, etc .; Endocrine pathologies such as thyroid diseases, ovarian or adrenal gland disorders; Any infection in the product analysis region diagnosed at the time of inclusion; Other conditions considered by the investigating physician as reasonable for the individual's disqualification from participation in the study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvements in vaginal hydration are expected to be seen in 85% of patients by gynecological evaluation after treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are not expected