Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Malignancy
• Intervention / Treatment: Other: CH2 vaginal gel; Other: vaginal rehabilitation exercises

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD; Phone Number: 886-2-23123456; Email: ntuhrec@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Cancer Center
    • Contact: Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD; Phone Number: 886-2-23123456; Email: ntuhrec@ntuh.gov.tw
    • Principal Investigator: Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CH2 vaginal gel; Female patients who have completed pelvic radiotherapy, participants will undergo a 12-week intervention with CH2 vaginal gel.	Other: CH2 vaginal gel; 12-week intervention with CH2 vaginal gel
Active Comparator: vaginal rehabilitation exercises; Female patients who have completed pelvic radiotherapy, participants will undergo a 12-week intervention with vaginal rehabilitation exercises.	Other: vaginal rehabilitation exercises; 12-week intervention with vaginal rehabilitation exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Function Index (FSFI) score	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.	From enrollment to the end of intervention at at 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD, National Taiwan University Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2025
• Primary Completion (Estimated): May 9, 2028
• Study Completion (Estimated): May 9, 2030

Study Registration Dates

• First Submitted: May 21, 2025
• First Submitted That Met QC Criteria: May 21, 2025
• First Posted (Actual): May 31, 2025

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: pelvic radiotherapy; CH2 vagina gel; vagina rehabilitation
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 202503152RIPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient privacy consideration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No