Gynecologic MalignancyNCT06997887
Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy
A study testing CH2 vaginal gel and vaginal rehabilitation exercises in people with Gynecologic Malignancy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Gynecologic Malignancy
- What is being tested?
- CH2 vaginal gel and vaginal rehabilitation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 May 2025to 9 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Cancer Center
Taipei
Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD, 886-2-23123456, ntuhrec@ntuh.gov.tw
Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD
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 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.
- Conditions
- Gynecologic Malignancy
- Being tested
- CH2 vaginal gel, vaginal rehabilitation exercises
- Keywords
- pelvic radiotherapy, CH2 vagina gel, vagina rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CH2 vaginal gelOther
12-week intervention with CH2 vaginal gel
vaginal rehabilitation exercisesOther
12-week intervention with vaginal rehabilitation exercises
| Study group | Role | What they receive |
|---|---|---|
| CH2 vaginal gel | Experimental | Female patients who have completed pelvic radiotherapy, participants will undergo a 12-week intervention with CH2 vaginal gel. Receives: 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. Receives: Other: vaginal rehabilitation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of intervention at at 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start9 May 2025
- Primary completion9 May 2028 (estimated)
- Study completion9 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic MalignancyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will undergo a 12-week intervention with either CH2 vaginal gel or vaginal rehabilitation exercises.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
- Investigators
- Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997887
- Sponsor's protocol ID
- 202503152RIPE
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient privacy consideration.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy
- ClinicalTrials.gov ID
- NCT06997887
- Acronym / sponsor ID
- 202503152RIPE
- Conditions
- Gynecologic Malignancy
- Keywords
- pelvic radiotherapy, CH2 vagina gel, vagina rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- 9 May 2028 (estimated)
- Study completion
- 9 May 2030 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will undergo a 12-week intervention with either CH2 vaginal gel or vaginal rehabilitation exercises.
| Arm | Type | Receives |
|---|---|---|
| CH2 vaginal gel | Experimental | Other: CH2 vaginal gelFemale patients who have completed pelvic radiotherapy, participants will undergo a 12-week intervention with CH2 vaginal gel. |
| vaginal rehabilitation exercises | Active comparator | Other: vaginal rehabilitation exercisesFemale patients who have completed pelvic radiotherapy, participants will undergo a 12-week intervention with vaginal rehabilitation exercises. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CH2 vaginal gel12-week intervention with CH2 vaginal gel | Other | CH2 vaginal gel |
| vaginal rehabilitation exercises12-week intervention with vaginal rehabilitation exercises | Other | vaginal rehabilitation exercises |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No. Patient privacy consideration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CH2 vaginal gel and vaginal rehabilitation exercises in people with Gynecologic Malignancy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD (886-2-23123456, ntuhrec@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) score (time frame: From enrollment to the end of intervention at at 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.