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Gynecological perceived efficacy of HB22

Clinical assessment of gynecological acceptability and subjective perceived efficacy under Normal conditions of use for Vaginal Moisture Restorative Moisturizer HB22

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-59q849
Enrollment
Unknown
Registered
2020-05-21
Start date
2023-04-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other specified noninflammatory disorders of vagina

Interventions

Initially, 70 participants will be recruited through their database profiles based on the inclusion and exclusion criteria informed in the item “Selection of Participants”. Only participants who are s

Sponsors

INFAN - Indústria Química e Farmacêutica Nacional
Lead Sponsor
INFAN - Indústria Química e Farmacêutica Nacional
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Vaginal hydration for up to 3 days, verified by subjective questionnaire gynecological examination.

Secondary

MeasureTime frame
secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactMarcelo Oliveira

INFAN - Indústria Química e Farmacêutica Nacional

marcelo.alvaro@hebron.com.br+55 (81) 3722-1333

Outcome results

None listed

Source: REBEC (via WHO ICTRP)