In postmenopausal women with symptoms of urogenital atrophy
Conditions
Interventions
A randomized clinical trial based on 96 postmenopausal women is to be conducted. Women undergoing follow-up care at the Unicamp Climacteric Outpatient Facility will be selected and randomized into fou
drug
N95.2
Sponsors
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM Unicamp
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM Unicamp
Eligibility
Sex/Gender
Female
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: Physiological menopause with amenorrhea over three years FSH> 30 IU Aged over 40 years and less than 75 years. Women are not on medication for hormonal treatment of menopausal symptoms in the last 6 months Women who have mammography and Pap smear in the last 12 months with appropriate result Women with symptoms of urogenital atrophy.
Exclusion criteria
Exclusion criteria: The patient's explicit refusal to participate Patient with bilateral oophorectomy Patients with a BMI less than 18.5 kg / m² or greater than 30 kg / m² Women who present contraindication to the use of topical estrogen, as follows: Absolute (recent myocardial infarction, severe hypertension, diabetes mellitus is difficult to control, history of thromboembolic disease, recent Liver failure, or severe, or activity, prior breast cancer , Cancer of the endometrium prior mammary dysplasia with atypical hyperplasia, genital bleeding of unknown origin) or relative (family history of breast cancer, endometrial hyperplasia prior Cholelithiasis) Women who have ulcerative colitis, Crohn's disease or diarrhea due to intestinal disease Women who have positive serology for HIV, Hepatitis B and C Patients on medication for depression or other psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Will be measured trophism, cytology, pH and vaginal collagen production at the beginning and end of treatment through physical examination and collection of laminates and vaginal biopsy in the first and last weeks of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Will also be measured genital and urological symptoms, aspects of sexuality and the level of serum concentration of estradiol, total and free testosterone, follicle stimulating hormone (FSH), androstenedione, dehydroepiandrosterone, dehydroepiandrosterone sulfate and SHBG in the first, sixth and last week of the study | — |
Countries
Brazil
Contacts
Public ContactAarão Pinto Neto
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM Unicamp
Outcome results
None listed