Tests hormone implants under the skin for menopause symptoms
Tests estradiol and testosterone implants placed under the skin in women with menopause symptoms.
Plain-language title generated from the registry record
Registry title: Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)
Key facts
- Where
- São Paulo, BrazilSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06343870, who can take part
Where in Brazil
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São PauloSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Sao Paulo General Hospital
- Trial code
- NCT06343870
- Record updated
- 29 December 2025
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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: use of medications that inhibit sexual desire; disabling illnesses; 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; inability to answer the questionnaires; diagnosis after psychological screening of moderate to severe anxiety/depression.