Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Mar 26, 2024

Keywords

ClinConnect Summary

The ESTIME clinical trial is exploring a new treatment for women experiencing menopause symptoms due to low levels of estrogen and testosterone. The study aims to see how effective small, under-the-skin implants of these hormones are in improving symptoms like hot flashes, mood changes, and sexual function. This trial is specifically for women who have been menopausal for 2 to 6 years, including those who have had their ovaries removed due to cervical cancer or those with premature ovarian failure.

To participate, women need to be between 65 and 74 years old or between 21 and 94 years old, have an active sex life, and have a body mass index (BMI) between 25 and 30. They should also be free from severe anxiety and depression, as evaluated by specific questionnaires. Participants will have regular check-ups to monitor their health and assess the effects of the treatment on their quality of life. This important study aims to offer new options for women struggling with menopausal symptoms and to better understand how these hormone implants can help.

Gender

FEMALE

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.