Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy

NCT06997887 | Recruiting

• 1 other identifier: 202503152RIPE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Malignancy

Keywords

pelvic radiotherapy; CH2 vagina gel; vagina rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CH2 vaginal gel

EXPERIMENTAL

Female patients who have completed pelvic radiotherapy, participants will undergo a 12-week intervention with CH2 vaginal gel.

Other: CH2 vaginal gel

vaginal rehabilitation exercises

ACTIVE COMPARATOR

Female patients who have completed pelvic radiotherapy, participants will undergo a 12-week intervention with vaginal rehabilitation exercises.

Other: vaginal rehabilitation exercises

Interventions

CH2 vaginal gel OTHER

12-week intervention with CH2 vaginal gel

CH2 vaginal gel

vaginal rehabilitation exercises OTHER

12-week intervention with vaginal rehabilitation exercises

vaginal rehabilitation exercises

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Cancer Center

Taipei, Taiwan

RECRUITING

Study Officials

• Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD

CONTACT

886-2-23123456; ntuhrec@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jenny Ling-Yu Chen, MD PhD

Model Details: Participants will undergo a 12-week intervention with either CH2 vaginal gel or vaginal rehabilitation exercises.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 31, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): May 9, 2028
• Study Completion (Estimated): May 9, 2030
• Last Updated: June 27, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)