Actively Recruiting
Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)
Led by University of Sao Paulo General Hospital · Updated on 2025-12-29
140
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Menopause time of 2 to 6 years
- Body Mass Index between 25 and 30 kg/m2
- Women who have had hysterectomy and ovariectomy due to cervical cancer
- Women under 40 years old with premature ovarian failure
- Active sex life
- No severe depression or anxiety, as confirmed by Beck questionnaires
You will not qualify if you...
- Disabling illnesses
- Use of medications that inhibit sexual desire
- Inability to answer questionnaires
- Severe hypertension with blood pressure > 160 x 90 mmHg in two measurements
- Clinical or subclinical thyroid dysfunction with TSH > 4 mIU/L
- Dyslipidemia with fasting triglycerides > 400 mg/dL
- Presence of occult blood in feces
- Hyperprolactinemia (>29 ng/mL)
- Fasting blood glucose > 100 mg/dL
- Presence of osteopenia or osteoporosis
- BIRADS classification ≥ 3 on mammography
- Endometrial echo > 4mm on transvaginal ultrasound
- Changes in oncotic colpocytology
- Moderate to severe anxiety or depression diagnosed after psychological screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil, 05401-000
Actively Recruiting
Research Team
A
André Malavasi, PhD
CONTACT
E
Edmund Baracat, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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