Promotion of Vaginal Health With CH2 Vaginal Gel After Pe... | NCT06997887

Studies
Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy

NCT06997887

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Jun 27, 2025Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Gynecologic Malignancy

Interventions

CH2 vaginal gel
vaginal rehabilitation exercises

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 9, 2025Actual

Primary Completion Date

May 9, 2028Estimated

Completion Date

May 9, 2030Estimated

First Submitted Date

May 21, 2025

First Submission Date that Met QC Criteria

May 21, 2025

First Posted Date

May 31, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2025

Last Update Posted Date

Jun 27, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

National Taiwan University Clinical Trial Center, Jenny Ling-Yu Chen, MD PhD, National Taiwan University HospitalPrincipal Investigator

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CH2 vaginal gel	Other	12-week intervention with CH2 vaginal gel	CH2 vaginal gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD	Contact	886-2-23123456		ntuhrec@ntuh.gov.tw

Overall Officials

Name	Affiliation	Role
Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD	National Taiwan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Cancer Center	Recruiting	Taipei			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Patient privacy consideration.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided