NCT06343870 Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)
| NCT ID | NCT06343870 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2026-08-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 140 participants in total. It began in 2025-12-18 with a primary completion date of 2026-08-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Edmund Baracat, PhD
PRINCIPAL INVESTIGATOR
Instituto do Coracao
Frequently Asked Questions
Who can join the NCT06343870 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06343870 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 140 participants.
Is NCT06343870 currently recruiting?
Yes, NCT06343870 is actively recruiting participants. Contact the research team at drandreluiz@usp.br for enrollment information.
Where is the NCT06343870 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06343870 clinical trial?
NCT06343870 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Edmund Baracat, PhD at Instituto do Coracao. The trial plans to enroll 140 participants.