Atrophic vaginitis
Conditions
Interventions
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women aged 45-70 years; 2. More than 12 months since the last natural menstruation, or spontaneous amenorrhea for more than 6 months but less than 12 months and serum FSH level > 40 mIU/ml, or more than 6 months after bilateral oophorectomy; 3. At least one vaginal symptom (intravaginal or extravaginal) from the following list, moderate or severe experienced within the past 30 days: (1) Feeling dry at least once a week; (2) feel itching at least once a week; (3) feel stimulation at least once a week; (4) feel soreness/pain at least once a week; (5) Pain related to sexual behavior at least once a week; 4. BMI between 18.5-30.0 kg/m2; 5. Breast nodules graded in grade 1-3 by breast ultrasonography, or mammography within 9 months before the start of the study meets the above criteria; 6. Participate voluntarily and sign the informed consent form; 7. Patients were able to adhere to the treatment protocol and complete the study.
Exclusion criteria
Exclusion criteria: 1. Hysterectomy or endometrial thickness >= 5 mm; 2. Thrombosis or thromboembolic disease within 6 months before enrollment; 3. Patients with undiagnosed abnormal genital tract bleeding; 4. There is a vaginal infection requiring treatment; 5. Have estrogen-dependent neoplasms; 6. Known or suspected malignant tumors; 7. Blood ALT and BUN values ??exceed 1.5 times the upper limit of normal, and blood Scr exceeds the upper limit of normal; 8. Those who are allergic to the drug and its excipients; 9. Received estrogen replacement therapy (including local and systemic medication) within 90 days before enrollment; received any drug for the treatment of postmenopausal atrophic vaginitis within three months; used corticosteroids 6 weeks before the start of the study Drug treatment; long-term application of corticosteroids (intermittent use of nasal spray or skin application, eye drops and ear drops is allowed), and other experimental drugs have been used within 3 months before enrollment in this trial; 10. Had vaginal or pelvic surgery within 60 days; 11. Severe heart disease, liver disease, kidney disease, endocrine disease, etc., blood pressure >= 160/95 mmHg, or hypertension that cannot be controlled by conventional medication, recurrent migraine that cannot be controlled by conventional treatment; 12. Diagnosed with a history of depression or severe mental illness; 13. Subjects judged by doctors to be unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maturity value;most bothersome symptom;symptoms of vaginal atrophy;vaginal health index score;female sexual function index; | — |
Countries
China
Contacts
Public ContactChun Fu
The Second Xiangya Hospital of Central South University
Outcome results
None listed