RecruitingNot ApplicableNCT06997887
Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy
Sponsor
National Taiwan University Hospital
Enrollment
60 participants
Start Date
May 9, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 20 YearsMax Age: 70 Years
Inclusion Criteria3
- 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 Criteria5
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
OTHERCH2 vaginal gel
12-week intervention with CH2 vaginal gel
OTHERvaginal rehabilitation exercises
12-week intervention with vaginal rehabilitation exercises
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06997887