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A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jun 2026 → Jun 2027
Primary endpoints removed 16 → 1 primary endpoints
See other at-risk trials from Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 2026 to Jun 2027 Show 10 more changesShow less
    • Primary endpoint(s) modified
    • Recruitment opened
    • Study completion pushed from Sep 2026 to Jun 2027
    • Enrollment target: 180 to 195
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2025 to Oct 15, 2025
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: 3 to 8
    • Study description shortened, about 16 words
    • Publications: details revised at 65 of 67 entries
  2. Primary completion date: Sep 2024 to Jun 2026
    • Start date: Jun 2024 to Oct 2025
    • Study completion date: Jun 2026 to Sep 2026
    v4
  3. Enrollment target: 98 to 180v3 Show 5 more changesShow less
    • Primary completion date: Mar 2023 to Sep 2024
    • Start date: Dec 2022 to Jun 2024
    • Study completion date: Jan 2026 to Jun 2026
    • Study description expanded, about 20 words
    • Study arms: 2 to 3
  4. Start date: Oct 2022 to Dec 2022
    • Study completion date: Nov 2025 to Jan 2026
    • Study description shortened, about 1 word
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The genito-urinary syndrome of menopause severely affects patients with a history of gynecological cancer, especially those diagnosed with breast cancer. At the present time, we do not have solid scientific evidence on treatments that can be effective and safe to address this pathology. Based on the above, we have developed our working hypothesis where it is postulated that the microfractionated laser treatment of C02, in conjunction with topical regenerative treatment, constitute an effective alternative in the management of vulvo-vaginal atrophy in oncological patients who have contraindicated hormonal treatments.
Trial Details
NCT Number NCT05585476
Lead Sponsor Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators: Lumenis Be Ltd., Mucosa Innovations, S.L.
Conditions
(from sponsor)		 Female Urogenital Diseases, Breast Cancer Female
Related terms Breast Neoplasms, Female Urogenital Diseases
Enrollment 195 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov