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.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2010
INTERVENTION: 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. CONDITION: Study with the purpose of check clinical non‐inferiority and tolerance of two vaginal cream based on the conjugated estrogen manufactured by different manufacturers. Women in post menopause with indications for estrogen replacement therapy. PRIMARY OUTCOME: Endometrium thickness ‐ test used: transvaginal ultrasound exam SECONDARY OUTCOME: Alterations in clinical examination (gynecological) ‐ Citology INCLUSION CRITERIA: Women in post menopause with indications for estrogen replacement therapy
Epistemonikos ID: 89f10646b3cd0bbd7df1c76678808bb4b6cf873a
First added on: Aug 25, 2024