Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-09

Study Completion Date

2030-05-09

Brief Summary

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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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Detailed Description

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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

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Gynecologic Malignancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will undergo a 12-week intervention with either CH2 vaginal gel or vaginal rehabilitation exercises.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CH2 vaginal gel

Female patients who have completed pelvic radiotherapy, participants will undergo a 12-week intervention with CH2 vaginal gel.

Group Type EXPERIMENTAL

CH2 vaginal gel

Intervention Type OTHER

12-week intervention with CH2 vaginal gel

vaginal rehabilitation exercises

Female patients who have completed pelvic radiotherapy, participants will undergo a 12-week intervention with vaginal rehabilitation exercises.

Group Type ACTIVE_COMPARATOR

vaginal rehabilitation exercises

Intervention Type OTHER

12-week intervention with vaginal rehabilitation exercises

Interventions

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CH2 vaginal gel

12-week intervention with CH2 vaginal gel

Intervention Type OTHER

vaginal rehabilitation exercises

12-week intervention with vaginal rehabilitation exercises

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No