Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

Sponsor
University of Sao Paulo General Hospital
Study ID
NCT06343870
Phase
PHASE3
Status
Recruiting
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Conditions

  • Estrogen Deficiency
  • Menopause
  • Testosterone Deficiency

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • testosterone pellet (100 mg) — DRUG
    Intervention arm: Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)
  • Placebo — DRUG
    Pellet of cholesterol (placebo)

Study Details

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.

Key Dates

First listed
Apr 3, 2024
Start date
Dec 18, 2025
Status verified
Dec 2025
Primary completion
Aug 18, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Testosterone
    Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)
  • Placebo Comparator: Placebo
    Subdermal implant-bioabsorbable placebo pellet (cholesterol)

Primary Outcome Measure

Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms [ Time Frame: 6 months ]

Central Contacts

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