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Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

RecruitingPhase 3Ages 18 Years - 60 YearsFemaleUniversity of Sao Paulo General Hospital
NCT06343870 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * menopause time of 2 to 6 years; * Body Mass Index between 25 and 30 kg/m2; * women hysterectomized and ovariectomized due to cervical cancer; * women with premature ovarian failure and under 40 years of age; * active sex life; * absence of severe depression and anxiety, confirmed by evaluation using the Beck (specific for depression) and Beck (specific for anxiety) questionnaires. Exclusion Criteria: * disabling illnesses; * use of medications that inhibit sexual desire; * inability to answer the questionnaires; * altered routine exams and comorbidities: * Severe hypertension with Blood Pressure measurement \> 160 x 90 mmHg in two measurements * clinical or subclinical thyroid dysfunction with Thyroid-stimulating hormone \> 4 mIU/L * dyslipidemia - fasting triglyceride level \> 400 mg/dL * presence of occult blood in feces * hyperprolactinemia (\>29ng/mL) * fasting blood glucose \> 100 mg/dL * presence of osteopenia or osteoporosis * BIRADS classification greater than or equal to 3 on mammography * presence of endometrial echo \> 4mm on transvaginal ultrasound * presence of changes in oncotic colpocytology * diagnosis after psychological screening of moderate to severe anxiety/depression.
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What it tests

  • testosterone pellet (100 mg)
  • Placebo
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Where

1 site
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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