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RecruitingNCT06997887Updated Jun 27, 2025

Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy

An interventional study of CH2 vaginal gel and vaginal rehabilitation exercises in Gynecologic Malignancy, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Gynecologic Malignancy

Keywords

  • pelvic radiotherapy
  • CH2 vagina gel
  • vagina rehabilitation
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherCH2 vaginal gel

    12-week intervention with CH2 vaginal gel

  • Othervaginal rehabilitation exercises

    12-week intervention with vaginal rehabilitation exercises

06

What researchers measure

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.

    Time frame: From enrollment to the end of intervention at at 3, 6, and 12 months

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Cancer Center
    Taipei, Taiwan
    • Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD · Contact · ntuhrec@ntuh.gov.tw · 886-2-23123456
    • Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Patient privacy consideration.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06997887
Lead sponsor
National Taiwan University Hospital
Responsible party
National Taiwan University Clinical Trial Center (Jenny Ling-Yu Chen, MD PhD, National Taiwan University Hospital) — Principal investigator
First posted
May 31, 2025
Start date
May 9, 2025
Primary completion
May 9, 2028 (estimated)
Completion
May 9, 2030 (estimated)
Last update
Jun 27, 2025

Study contacts

Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD
Contact
ntuhrec@ntuh.gov.tw
886-2-23123456
Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD
principal investigator · National Taiwan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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