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New treatment option for Menopause
Official title Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)
ClinicalTrials.gov ID: NCT06343870
What this study is testing
What is testosterone pellet (100 mg)?
testosterone pellet (100 mg) is an investigational medicine, given as a monthly, being studied as a potential treatment for menopause.
Also referred to as testosterone subdermal implant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join if
- 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;
You likely can't join if
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.