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RECRUITING
NCT06343870
PHASE3

Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

Sponsor: University of Sao Paulo General Hospital

View on ClinicalTrials.gov

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.

Official title: Pharmacokinetic, Clinical, Hormonal and Therapeutic Effects of the Use of Estradiol and Testosterone Hormonal Subdermal Implants in Women With Natural Menopause, Premature Ovarian Failure or Surgical Menopause Due to Cervical Cancer.

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-12-18

Completion Date

2027-04-30

Last Updated

2025-12-29

Healthy Volunteers

No

Interventions

DRUG

testosterone pellet (100 mg)

Intervention arm: Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)

DRUG

Placebo

Pellet of cholesterol (placebo)

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil