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Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

Study acronym: ESTIME
StatusRecruiting
PhasePhase 3
Started2025-12-18
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 29, 2025 (before its estimated August 18, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-12-20
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-01-31→2026-08-18
Completion date2025-04-30→2027-04-30
Start dateestimated 2024-05-31→confirmed 2025-12-18
Study sites0→1
2024-03-26
minor
Original filing
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.
Trial Details
NCT Number NCT06343870
Lead Sponsor University of Sao Paulo General Hospital
Conditions Menopause, Testosterone Deficiency, Estrogen Deficiency
Enrollment 140 participants
Start Date 2025-12-18
Primary Completion 2026-08-18 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-29