RecruitingPhase 3NCT06343870

Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

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.

Sponsor

University of Sao Paulo General Hospital

Enrollment

140 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Menopause Testosterone Deficiency Estrogen Deficiency

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

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether small implants placed under the skin that slowly release estradiol and testosterone can improve symptoms of menopause — including sexual function, mood, and quality of life — in women who have had their uterus and ovaries removed or have premature ovarian failure. **You may be eligible if...** - You are a woman who went through menopause 2 to 6 years ago - You have had your uterus and ovaries removed (for cervical cancer treatment) or have premature ovarian failure and are under 40 - Your BMI is between 25 and 30 kg/m² - You are sexually active and do not have severe depression or anxiety **You may NOT be eligible if...** - You have disabling illnesses or take medications that reduce sexual desire - You have poorly controlled high blood pressure, thyroid problems, very high triglycerides, or elevated blood sugar - You have signs of precancerous or abnormal breast or uterine findings on exam - You have osteoporosis or osteopenia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.