NCT06343870RecruitingPhase 3
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.
Source: ClinicalTrials.gov · Last updated 29 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 18 Mar 2024
- Start date
- 18 Dec 2025
- Primary completion date
- 18 Aug 2026
- Lead sponsor
- University of Sao Paulo General Hospital
- Diseases
- Cervical cancer, Ovarian cancer
- NCT number
- NCT06343870
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 140
- From 18 Dec 2025 to the primary completion date, 18 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- use of medications that inhibit sexual desire;
Other illness
- disabling illnesses;
Lab values
- 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
Other
- inability to answer the questionnaires;
- diagnosis after psychological screening of moderate to severe anxiety/depression.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.