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Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)
Sponsor: University of Sao Paulo General Hospital
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.
Official title: Pharmacokinetic, Clinical, Hormonal and Therapeutic Effects of the Use of Estradiol and Testosterone Hormonal Subdermal Implants in Women With Natural Menopause, Premature Ovarian Failure or Surgical Menopause Due to Cervical Cancer.
Key Details
Gender
FEMALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-12-18
Completion Date
2027-04-30
Last Updated
2025-12-29
Healthy Volunteers
No
Interventions
testosterone pellet (100 mg)
Intervention arm: Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)
Placebo
Pellet of cholesterol (placebo)
Locations (1)
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil