Clinical trial · Interventional
Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy
NCT06997887CI-TRIAL-00091505recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CH2 vaginal gel | Other | — | UNRESOLVED |
| vaginal rehabilitation exercises | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CH2 vaginal gel
- description
- Female patients who have completed pelvic radiotherapy, participants will undergo a 12-week intervention with CH2 vaginal gel.
- interventionNames
- Other: CH2 vaginal gel
- type
- ACTIVE_COMPARATOR
- label
- vaginal rehabilitation exercises
- description
- Female patients who have completed pelvic radiotherapy, participants will undergo a 12-week intervention with vaginal rehabilitation exercises.
- interventionNames
- Other: vaginal rehabilitation exercises
Primary outcomes (1)
- measure
- Female Sexual Function Index (FSFI) score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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: 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.
References
Publications (0)
Data not yet available
No reference posted for this study.