Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy

Not Applicable

Recruiting

• Conditions: Gynecologic Malignancy

• Registration Number: NCT06997887
• Lead Sponsor: National Taiwan University Hospital

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 rehabilitation exercises. The primary endpoint is the change in the Female Sexual Function Index scores.

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 rehabilitation exercises. The primary endpoint is the change in the Female Sexual Function Index (FSFI) scores. Follow-up assessments will be conducted to determine whether CH2 vaginal gel or vaginal rehabilitation can improve post-radiotherapy vaginal health and enhance the long-term quality of life for women with cancer.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-09
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Study First Posted: 2025-05-31
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-27
• Primary Completion: 2028-05-09
• Study Completion: 2030-05-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Female Sexual Function Index (FSFI) score	From enrollment to the end of intervention at at 3, 6, and 12 months	Female Sexual Function Index (FSFI) score. The score ranges from a minimum of 2 to a maximum of 36. Higher scores indicate better sexual function.

Trial Locations

Locations (1)

National Taiwan University Cancer Center; 🇨🇳 Taipei, Taiwan