Vulvovaginal atrophy
Conditions
Interventions
The control group:oral placebo
Sponsors
Second Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. aged 45-65 years old, menopause more than 1 year; 2. patients complained of vulvovaginal atrophy symptoms, such as vaginal dryness, vaginal or genital itching, painful sexual intercourse; 3. vaginal epithelial maturity index (VMI) = 10%, vaginal pH> 5; 4. FSH= 40mIU/ml, E2= 20 pg/ml; 5. Signed informed consent.;Inclusion criteria: 1. aged 45-65 years old, menopause more than 1 year; 2. patients complained of vulvovaginal atrophy symptoms, such as vaginal dryness, vaginal or genital itching, painful sexual intercourse; 3. vaginal epithelial maturity index (VMI) = 10%, vaginal pH> 5; 4. FSH= 40mIU/ml, E2= 20 pg/ml; 5. Signed informed consent.;Inclusion criteria: 1. aged 45-65 years old, menopause more than 1 year; 2. patients complained of vulvovaginal atrophy symptoms, such as vaginal dryness, vaginal or genital itching, painful sexual intercourse; 3. vaginal epithelial maturity index (VMI) = 10%, vaginal pH> 5; 4. FSH= 40mIU/ml, E2= 20 pg/ml; 5. Signed informed consent.;Inclusion criteria: 1. aged 45-65 years old, menopause more than 1 year; 2. patients complained of vulvovaginal atrophy symptoms, such as vaginal dryness, vaginal or genital itching, painful sexual intercourse; 3. vaginal epithelial maturity index (VMI) = 10%, vaginal pH> 5; 4. FSH= 40mIU/ml, E2= 20 pg/ml; 5. Signed informed consent.;Inclusion criteria: 1. aged 45-65 years old, menopause more than 1 year; 2. patients complained of vulvovaginal atrophy symptoms, such as vaginal dryness, vaginal or genital itching, painful sexual intercourse; 3. vaginal epithelial maturity index (VMI) = 10%, vaginal pH> 5; 4. FSH= 40mIU/ml, E2= 20 pg/ml; 5. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. With a history of reproductive system malignancy (such as endometrial cancer, ovarian cancer, cervical cancer, etc.) and breast cancer; 2. Unexplained uterine bleeding; 3. vulvovaginal other diseases, such as: vestibular prostatitis, vestibular glandular abscess, bacterial vaginitis, Candida albicans infection, trichomonas vaginitis; 4. Combined with severe cervicitis, cervical erosion, sexually transmitted diseases; 5. Liquid - based cytology abnormalities; 6. Endometrial thickness of vagina under ultrasound> 5mm; 7. B-breast hyperplasia or other significant abnormal breast hyperplasia; 8. Combined with severe disease of heart, liver, kidney, hematopoietic and other important organs and systems; 9. With diabetes, active central nervous system disorders or blood diseases; 10. Combined with neurological and mental disorders can not cooperate or unwilling to cooperate; 11. Those who are allergic to the constituents of the test drug and those who are allergic; 12. Take antidepressant, antipsychotic or containing its ingredients of drugs in 3 months; 13. Those who were treated within 1 month; 14. Patients who have participated in other clinical trials in the past 2 months; 15. Due to residence, work and other reasons can not be regularly followed up.;Exclusion criteria: 1. With a history of reproductive system malignancy (such as endometrial cancer, ovarian cancer, cervical cancer, etc.) and breast cancer; 2. Unexplained uterine bleeding; 3. vulvovaginal other diseases, such as: vestibular prostatitis, vestibular glandular abscess, bacterial vaginitis, Candida albicans infection, trichomonas vaginitis; 4. Combined with severe cervicitis, cervical erosion, sexually transmitted diseases; 5. Liquid - based cytology abnormalities; 6. Endometrial thickness of vagina under ultrasound> 5mm; 7. B-breast hyperplasia or other significant abnormal breast hyperplasia; 8. Combined with severe disease of heart, liver, kidney, hematopoietic and other important organs and systems; 9. With diabetes, active central nervous system disorders or blood diseases; 10. Combined with neurological and mental disorders can not cooperate or unwilling to cooperate; 11. Those who are allergic to the constituents of the test drug and those who are allergic; 12. Take antidepressant, antipsychotic or containing its ingredients of drugs in 3 months; 13. Those who were treated within 1 month; 14. Patients who have participated in other clinical trials in the past 2 months; 15. Due to residence, work and other reasons can not be regularly followed up.;Exclusion criteria: 1. With a history of reproductive system malignancy (such as endometrial cancer, ovarian cancer, cervical cancer, etc.) and breast cancer; 2. Unexplained uterine bleeding; 3. vulvovaginal other diseases, such as: vestibular prostatitis, vestibular glandular abscess, bacterial vaginitis, Candida albicans infection, trichomonas vaginitis; 4. Combined with severe cervicitis, cervical erosion, sexually transmitted diseases; 5. Liquid - based cytology abnormalities; 6. Endometrial thickness of vagina under ultrasound> 5mm; 7. B-breast hyperplasia or other significant abnormal breast hyperplasia; 8. Combined with severe disease of heart, liver, kidney, hematopoietic and other important organs and systems; 9. With diabetes, active central nervous system disorders or blood diseases; 10. Combined with neurological and mental disorders can not cooperate or unwilling to cooperate; 11. Those who are allergic to the constituents of the test drug and those who are allergic; 12. Take antidepressant, antipsychotic or containing its ingredients of drugs in 3 months; 13. Those who were treated within 1 month; 14. Patients who have participated in other clinical trials in the past 2 months; 15. Due to residence, work and other reasons can not be regularly followed up.;Exclusion criteria: 1. With a history of reproductive system malignancy (such as endometrial cancer, ovarian cancer, cervical cancer, etc.) and breast cancer; 2. Unexplained uterine bleeding; 3. vulvovaginal other diseases, such as: vestibular prostatitis, vestibular glandular abscess, bacterial vaginitis, Candida albicans infection, trichomonas vaginitis; 4. Combined with severe cervicitis, cervical erosion, sexually transmitted diseases; 5. Liquid - based cytology abnormalities; 6. Endometrial thickness of vagina under ultrasound> 5mm; 7. B-breast hyperplasia or other significant abnormal breast hyperplasia; 8. Combined with severe disease of heart, liver, kidney, hematopoietic and other important organs and systems; 9. With diabetes, active central nervous system disorders or blood diseases; 10. Combined with neurological and mental disorders can not cooperate or unwilling to cooperate; 11. Those who are allergic to the constituents of the test drug and those who are allergic; 12. Take antidepressant, antipsychotic or containing its ingredients of drugs in 3 months; 13. Those who were treated within 1 month; 14. Patients who have participated in other clinical trials in the past 2 months; 15. Due to residence, work and other reasons can not be regularly followed up.;Exclusion criteria: 1. With a history of reproductive system malignancy (such as endometrial cancer, ovarian cancer, cervical cancer, etc.) and breast cancer; 2. Unexplained uterine bleeding; 3. vulvovaginal other diseases, such as: vestibular prostatitis, vestibular glandular abscess, bacterial vaginitis, Candida albicans infection, trichomonas vaginitis; 4. Combined with severe cervicitis, cervical erosion, sexually transmitted diseases; 5. Liquid - based cytology abnormalities; 6. Endometrial thickness of vagina under ultrasound> 5mm; 7. B-breast hyperplasia or other significant abnormal breast hyperplasia; 8. Combined with severe disease of heart, liver, kidney, hematopoietic and other important organs and systems; 9. With diabetes, active central nervous system disorders or blood diseases; 10. Combined with neurological and mental disorders can not cooperate or unwilling to cooperate; 11. Those who are allergic to the constituents of the test drug and those who are allergic; 12. Take antidepressant, antipsychotic or containing its ingredients of drugs in 3 months; 13. Those who were treated within 1 month; 14. Patients who have participated in other clinical trials in the past 2 months; 15. Due to residence, work and other reasons can not be regularly followed up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal Health Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginitis score;Vaginal epithelial maturation index;female sexual function index;Improved Kupperman score;Blood lipids (triglycerides, cholesterol, high-density lipoprotein, low-density lipoprotein);Bone mineral density; | — |
Countries
China
Contacts
Public ContactDianrong Song;Dianrong Song;Dianrong Song;Dianrong Song;Dianrong Song ;;;;
Second Hospital Affiliated to Tianjin University of Traditional Chinese Medicine;Second Hospital Affiliated to Tianjin University of Traditional Chinese Medicine;Second Hospital Affiliated to Tianjin University of Traditional Chinese Medicine;Second Hospital Affiliated to Tianjin University of Traditional Chinese Medicine;Second Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Outcome results
None listed