None listed
Conditions
Brief summary
Patients at post-menopause phase, after signing Free and Informed Consent Term, shall pass through medical consultation and laboratorial exams (clinical analysis) including plasmatic dosing of Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), Glutamate Oxaloacetate Transaminase (GOT) and glutamic-pyruvic transaminase (GPT), calcium and Total Estrogen (Estradiol) and Free Estrogen (Free Estriol), Glucose and total Cholesterol. A mammography will be performed in order to exclude patients with counter indication for the drug use. Patients shall be sent to undergo transvaginal ultrasound exam in order to assess their endometrium thickness. During medical consultation, vaginal walls as well as the cervix will be scraped for functional cytological and oncologic exam, using Papanicolaou test method. The procedures, in total or in part, shall be repeated at the following visits, within three months follow-up time period.
Interventions
Estrogenon (conjugated estrogens), vaginal cream 0,625mg/g manufactured by Sanval Comercio e Industria Ltda,administered once a each two days for a total of 90 days, applied with cream disposable applicator, in comparasion to Premarin(Estrogen conjugated) 0,625 mg/g manufactured by Wyeth Industria Farmaceutica Ltda, taken once the each two days for a total of 90 days, administrated by cream disposable applicator.
Sponsors
Sanval Comercio e Industria Ltda.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes
Inclusion criteria
Women in post menopause with indications for estrogen replacement therapy
Exclusion criteria
Patients with contraindications for estrogen use
Outcome results
None listed