Not Yet RecruitingPhase 3ACTRN12610000119099

Study for the assessment of clinical non-inferiority and tolerability of Estrogenon (Sanval Comercio e Industria Ltda) in comparasion to Premarin (Wyeth Industria Farmaceutica Ltda) in women post menopause.

Study for the assessment of clinical non-inferiority and tolerability of Estrogenon drug – conjugated estrogens, coated tablets coated tablet manufactured by Sanval Comercio e Industria Ltda. in comparison to (PREMARIN) coated tablets manufactured by Wyeth Industria Farmaceutica Ltda. in women post menopause

Sponsor

Sanval Comercio e Industria Ltda

Enrollment

66 participants

Start Date

Mar 1, 2010

Study Type

Interventional

Conditions

Study with the purpose of check clinical non- inferiority and tolerance of conjugated estrogen coated tablet manufactured by different manufactures Women in post menopause with indications for estrogens replacement therapy.

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.

Eligibility

Sex: Females

Plain Language Summary

Simplified for easier understanding

This study compares two estrogen cream products for postmenopausal women who need hormone replacement therapy. Women who are past menopause and have a medical need for estrogen therapy may participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Estrogen drug - conjugated estrogens, coated tablets 0,625mg/coated tablet manufactured by Sanval Comercio e Industria Ltda,taken orally once a day for a total of 90 days, in comparasion to Premarin 0,625 mg/coated tablet manufactured by Wyeth Industria Farmaceutica Ltda, taken orally once a day also for a total of 90 days.

Locations(1)

Minas Gerais, Brazil

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ACTRN12610000119099