Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME) (NCT06343870) | Clinical Trial Compass
RecruitingPhase 3
Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)
Brazil140 participantsStarted 2025-12-18
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms