Using CH2 vaginal gel or vaginal rehabilitation exercises to improve vaginal health after pelvic radiotherapy
Official title: Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy
Run by National Taiwan University Hospital · NCT06997887 · Data updated 2026-11-12
This project will test whether CH2 vaginal gel or vaginal rehabilitation exercises help women who completed pelvic radiotherapy improve vaginal health and sexual function.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 70 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | May 9, 2025 |
| Main results expected | May 9, 2028 |
| Study ends | May 9, 2030 |
| Registry record updated | June 27, 2025 |
| Trial ID | NCT06997887 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 20–70 who have completed pelvic radiotherapy for gynecologic cancer, have ECOG performance status 0–1, and can self-administer the assigned intervention and attend follow-up visits.
✕Probably not a fit
Patients with distant metastases or recent active malignancy, severe uncontrolled comorbidities, major psychiatric or social barriers, inability to self-administer the intervention, or those outside the 20–70 age range may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective enrollment will offer eligible women a 12-week intervention of either CH2 vaginal gel or a program of vaginal rehabilitation exercises. Participants will be followed with standardized questionnaires, including the Female Sexual Function Index (FSFI), to measure changes from baseline. The primary outcome is change in FSFI scores, with additional follow-up to track vaginal symptoms and quality of life. The goal is to determine which approach better supports long-term vaginal health after pelvic radiotherapy.
Why it matters
Potential benefit: If successful, the intervention could reduce post-radiotherapy vaginal symptoms and improve sexual function and quality of life for affected women.
How similar studies have gone: Related approaches such as vaginal moisturizers, dilator use, and pelvic floor rehabilitation have shown some benefit for post-radiotherapy vaginal symptoms, but CH2 gel specifically is relatively novel and less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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National Taiwan University Cancer Center
Taipei, Taiwan Recruiting
Study contacts
- Principal investigator: Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD — National Taiwan University
- Study coordinator: Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD
- Email: ntuhrec@ntuh.gov.tw
- Phone: 886-2-23123456
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.