Overview

Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

Status:
NOT_YET_RECRUITING
Trial end date:
2025-04-30
Target enrollment:
Participant gender:
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.
Phase:
PHASE3
Details
Lead Sponsor:
University of Sao Paulo General Hospital