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NCT Number: NCT06997887

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.

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Key information

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Cancer Center

Taipei, Taiwan

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

886-2-23123456

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

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

CH2 vaginal gel

Other

12-week intervention with CH2 vaginal gel

vaginal rehabilitation exercises

Other

12-week intervention with vaginal rehabilitation exercises

Primary outcomes

  1. Female Sexual Function Index (FSFI) score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

886-2-23123456

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
May 31, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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