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Local Application of Promestriene Vaginal soft Capusules for the Prevention of Radiotherapy-associated Complication: a Single-center, Prospective Study.

Local Application of for the Prevention of Radiotherapy-associated Complication: a Single-center, Prospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095709
Enrollment
Unknown
Registered
2025-01-10
Start date
2025-01-10
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer

Interventions

Observation group (Cervical cancer patients receiving radiotherapy and using progestin):None
Control group (Cervical cancer patients who received radiation therapy but did not use progesterone):None

Sponsors

the First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in this study and sign an informed consent form; 2. Aged 18 years or older but less than 75 years; 3. ECOG performance status 0-2 and no contraindications to radiation therapy; 4. Histologically confirmed cervical adenocarcinoma, squamous cell carcinoma, or adeno-squamous cell carcinoma associated with HPV infection, without bladder or rectal affected before treatment, and initial treatment requires both external and intracavitary radiotherapy; 5. No use of estrogen or related drugs within 3 months prior to treatment; 6. No contraindications to the use of progesterone; 7. Willing to comply with the trial and follow-up procedures.

Exclusion criteria

Exclusion criteria: 1. Unknown cause of vaginal bleeding; 2. Known or suspected estrogen-dependent diseases (uterine fibroids, adenomyoma, adenomyosis, uterine sarcoma, breast cancer, etc.); 3. Contraindications to estrogen use (including recent myocardial infarction, severe hypertension, refractory diabetes mellitus, active venous or arterial thromboembolic disease in the last 6 months, decompensated hepatic disease, history of breast cancer, mammary dysplasia with atypical hyperplasia, family history of breast cancer); 4. History of local or systemic use of estrogen and related drugs in the last 3 months; 5. Suffering from acute inflammatory diseases of the genital tract, including gonorrhea, severe bacterial, fungal, trichomonas vaginitis, mycoplasma or chlamydia infections; 6. Ever having suffered a previous open vaginal injury; 7. Comorbid with vaginal ulcers or fistulas; 8. Poor compliance, not accepting the whole treatment and follow-up.

Design outcomes

Primary

MeasureTime frame
Incidence of radiation vaginitis ;Incidence of vaginal stenosis;Radiation-induced bladder injury;

Secondary

MeasureTime frame
Evaluation of vaginal secretions;Cleanliness of vaginal secretions;Vaginal microecology;HPV conversion rate;Radiation-induced rectal injury;

Countries

China

Contacts

Public ContactRuixia Guo

the First Affiliated Hospital of Zhengzhou University

grxcdxzzu@163.com+86 135 2556 9376

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026