Not Yet RecruitingPhase 3ACTRN12610000103066

Study for the assessment of clinical non-inferiority and tolerability of different conjugated estrogen vaginal cream ESTROGENON (Sanval Comercio e Industria Ltda) versus PREMARIN (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

Women in post menopause with indications for estrogen replacement therapy.Study with the purpose of check clinical non-inferiority and tolerance of two vaginal cream based on the conjugated estrogen manufactured by different manufacturers.

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 vaginal estrogen cream products for postmenopausal women who need estrogen replacement therapy. Women who are past menopause and have no contraindications to estrogen use 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

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.

Locations(1)

Brazil

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ACTRN12610000103066