Subdermal estradiol and testosterone implants for relieving menopausal symptoms
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.
This project will try bioabsorbable subdermal estradiol and testosterone implants in women with menopause-related estrogen and testosterone deficiency to see if they reduce menopausal and sexual symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06343870 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional trial will enroll 140 women divided into three groups: natural postmenopausal women with symptoms, women with premature ovarian failure, and women with surgical menopause after hysterectomy for cervical cancer. Participants will receive subdermal bioabsorbable estradiol and a 100 mg testosterone pellet or placebo and be followed for six months with visits at baseline, 1, 3, and 6 months. The protocol includes intensive pharmacokinetic sampling shortly after implant insertion and monthly, plus hormone, biochemical, metabolic, thromboembolic and imaging tests and standardized questionnaires on quality of life, menopausal symptoms, and sexual function. Clinical and laboratory outcomes will be compared over time using nonparametric tests and chi-square analysis for categorical improvements.
Who should consider this trial
Good fit: Women 2–6 years postmenopause, women under 40 with premature ovarian failure, or women with surgical menopause after hysterectomy and bilateral adnexectomy who have an active sex life, BMI 25–30 kg/m2, and no severe depression or disqualifying comorbidities are ideal candidates.
Not a fit: Women with uncontrolled hypertension, clinical/subclinical thyroid dysfunction, very high triglycerides or fasting glucose, osteopenia/osteoporosis, hyperprolactinemia, use of medications that inhibit sexual desire, or inability to complete questionnaires may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could offer sustained relief of menopausal and sexual symptoms with steady hormone delivery and fewer daily dosing issues.
How similar studies have performed: Oral and transdermal estrogen and testosterone therapies have shown benefit for menopausal symptoms and sexual function, but bioabsorbable subdermal implants have a smaller and less mature evidence base.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, São Paulo
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Edmund Baracat, PhD — Instituto do Coracao
- Study coordinator: André Malavasi, PhD
- Email: drandreluiz@usp.br
- Phone: 55 11 981348231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.