Evaluation of four types of therapies for the treatment of urogenital atrophy in postmenopausal wome

Not Applicable

Not yet recruiting

• Conditions: In postmenopausal women with symptoms of urogenital atrophy; N95.2

• Registration Number: RBR-2wjrp4
• Lead Sponsor: Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM Unicamp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: not yet recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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