Clinical Trial

Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

Study acronym: ESTIME
Recruiting Phase 3
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Summary
Estrogen and androgen deficiencies negatively impact the quality of life of women at different stages of life, especially after menopause. New modalities and new therapeutic alternatives have been researched. Parenteral administration of estradiol and testosterone could be effective to treat symptoms secondary to estrogen and androgen deficiencies and minimize these adverse events. This study evaluates the efficiency of subdermal implant-bioabsorbable use in women with menopausal symptoms associated with secondary estrogen and androgen deficiencies in women with natural menopause, premature ovarian failure or surgical menopause due to cervical cancer. Pharmacokinetic, biochemical, metabolic, thromboembolic and hormonal data will be evaluated, as well as the effects on quality of life, menopausal symptoms and sexual function after treatment.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-03-26.
Status change: Not Yet Recruiting → Recruiting 2025-12-20
Trial Details
NCT Number NCT06343870
Lead Sponsor University of Sao Paulo General Hospital
Conditions Menopause, Testosterone Deficiency, Estrogen Deficiency
Enrollment 140 participants
Start Date 2025-12-18
Primary Completion 2026-08-18 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-29