Status:

RECRUITING

Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy

Lead Sponsor:

National Taiwan University Hospital

Conditions:

Gynecologic Malignancy

Eligibility:

FEMALE

20-70 years

Phase:

NA

Brief Summary

This is a prospective clinical trial planning to enroll female patients who have completed pelvic radiotherapy. Participants will undergo a 12-week intervention with either CH2 vaginal gel or vaginal ...

Detailed Description

This is a prospective clinical trial planning to enroll female patients who have completed pelvic radiotherapy. Participants will undergo a 12-week intervention with either CH2 vaginal gel or vaginal ...

Eligibility Criteria

Inclusion

  • Female patients aged between 20 and 70 years.
  • Completion of pelvic radiotherapy for gynecologic cancer, which may include external beam radiotherapy (EBRT), brachytherapy (BT), or a combination of both.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.

Exclusion

  • Individuals under the age of 18.
  • Presence of distant metastases or a history of malignancy currently under treatment within the past five years (excluding non-melanoma skin cancer).
  • Presence of severe comorbidities, such as uncontrolled diabetes, cardiovascular disease, or autoimmune disorders that may interfere with treatment or study participation.
  • Diagnosed psychiatric disorders or significant social factors that may prevent adherence to study requirements or completion of follow-up evaluations.
  • Inability to self-administer vaginal gel or vaginal rehabilitation exercises.

Key Trial Info

Start Date :

May 9 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 9 2030

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06997887

Start Date

May 9 2025

End Date

May 9 2030

Last Update

June 27 2025

Active Locations (1)

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1

National Taiwan University Cancer Center

Taipei, Taiwan