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.
Phase 3
- Conditions
- Study with the purpose of check clinical non- inferiority and tolerance of conjugated estrogen coated tablet manufactured by different manufacturesReproductive Health and Childbirth - Menstruation and menopauseWomen in post menopause with indications for estrogens replacement therapy.
- Registration Number
- ACTRN12610000119099
- Lead Sponsor
- Sanval Comercio e Industria Ltda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 66
Inclusion Criteria
Women in menopause with indications for estrogen replacement therapy.
Exclusion Criteria
Patients with contraindications for estrogen use.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endometium thickness; alterations in clinical examination (gynecological)[at 90 days from baseline.]
- Secondary Outcome Measures
Name Time Method il[Nil]
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms differentiate Estrogenon (Sanval) from Premarin (Wyeth) in conjugated estrogen therapy for postmenopausal women?
How does Estrogenon (Sanval) compare to Premarin (Wyeth) in non-inferiority and tolerability for menopausal hormone replacement therapy?
Which biomarkers, such as ESR1 or CYP19A1, predict response to conjugated estrogen therapies in ACTRN12610000119099 postmenopausal patients?
What adverse event profiles and management strategies are reported for Estrogenon (Sanval) versus Premarin (Wyeth) in ACTRN12610000119099 Phase III trial?
Are there alternative estrogen formulations or combination therapies to Estrogenon (Sanval) and Premarin (Wyeth) for managing menopausal symptoms in postmenopausal women?