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NCT Number: NCT06508788

Combination of the Vaginal Laser With a Moisturizing and Repairing Niosomal Gel in the Treatment of Genitourinary Syndrome in Oncology Patients

Vaginal laser together with the use of moisturizing and repairing gels could be an effective therapy for the treatment of genitourinary syndrome in women with a history of neoplasia in whom the use of estrogens is not recommended.

The purpose of this study is to evaluate the effectiveness of vaginal laser together with adjuvant treatment with a hydrating and repairing niosomal gel as a beneficial treatment in this group of patients.

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Key information

Conditions

Genitourinary Syndrome of Menopause

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Carlos

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location status: Recruiting

Location contact

Carlos Ortega-Expósito

CONTACT

[email protected]

932607500 ext. 6814

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with an established SGM diagnosis.
  • Patients with a history of neoplasia in whom the use of estrogens as the first alternative for the treatment of GMS is not recommended.

Exclusion criteria

  • Patients with concomitant vulvovaginal pathology.
  • Patients with a diagnosis of pelvic organ prolapse grade II or greater.

Treatment and study plan

CO2 laser

Device

Application of CO2 vulvo-vaginal laser according to standard therapy and moisturizing gels

Primary outcomes

  1. Effectiveness

    Time frame: 12 months

    To evaluate the effectiveness of CO2 vaginal laser together with adjuvant treatment with a hydrating and repairing niosomal gel as a beneficial treatment in patients with a history of neoplasia in whom the use of estrogens is not recommended

Secondary outcomes

  1. Security

    Time frame: 12 months

    To determine the safety (side effects) of vaginal laser therapy

  2. Duration

    Time frame: 12 months

    To determine the durability of the effects produced by vaginal laser therapy

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

Combinación Del láser Vaginal Con un Gel Niosomal Hidratante y Reparador en el Tratamiento Del síndrome Genitourinario en Pacientes oncológicas

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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