Hormone pellet study tracks estrogen levels for six months
NCT ID NCT06136208
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looked at how a 25-mg estradiol pellet, placed under the skin, releases estrogen over 24 weeks in 20 postmenopausal women. Researchers took many blood samples to measure hormone levels and understand the pellet's release pattern. The goal was to gather detailed information on how the body absorbs this form of hormone therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- estradiol pellet
- What this could lead to
- If successful, this could help doctors better understand how estradiol pellets work, leading to more precise hormone therapy dosing for menopause symptoms.
- What could go wrong
- This is a small, completed study with only 20 participants, so results may not apply to all women. It measured hormone levels, not symptom relief or long-term safety.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
20 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
41 to 59 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed Informed Consent Form * Woman aged ≥ 41 and ≤ 59 years * Weight ≥ 50 kg and ≤ 98 kg * BMI ≥ 18.5 and ≤ 34.9 kg/m² * Hysterectomy (with or without oophorectomy) * Serum total estradiol concentration ≤ 50 pg/mL and serum FSH concentration ≥ 25 mIU/mL, both determined by immunoassays * Presence of menopause-associated symptoms * Absence of signs and symptoms and propedeutics suggestive of breast cancer evidenced by mammography report (woman aged \> 40 years) for less than 12 months = BI-RADS1 or BI-RADS2 * Agreement not to use other hormones (estrogens, androgens and/or progestogens) in any pharmaceutical form during the study Exclusion Criteria: * Contraindications to the use of menopausal hormone therapy: Bleeding vaginal of unknown cause; personal history of hormone-dependent neoplasm including breast cancer, precursor lesions of breast cancer; liver disease; porphyria; personal history of coronary artery disease, cerebrovascular and venous thromboembolism; systemic lupus erythematosus with high thromboembolic risk and meningioma * Comorbidities associated with increased cardiovascular risk: smoking, uncontrolled diabetes, dyslipidemia, and uncontrolled hypertension * Serious chronic disorders, including metastatic malignancies, kidney disease in the end-stage with or without dialysis, clinically unstable heart disease, or any another disorder that, in the opinion of the investigator, excludes the participant from the study * Immunocompromise or suspected or confirmed diagnosis of immunodeficiency based on history and/or physical or laboratory examination * Active liver disease or dysfunction * Benign or malignant tumors of the liver * Clinical diagnosis of polycystic ovary syndrome * Use of other hormones (estrogens, androgens and/or progestogens) in any pharmaceutical form in the last month * Current use of drugs that alter cytochrome P450 and metabolization of Estrogens * Current use of tamoxifen, aromatase inhibitors, or agonists/antagonists GnRH for cancer or any other condition * Current use of phytoestrogens * Participation in another clinical study within 30 days prior to the start of the Study treatment
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Irmandade Da Santa Casa De Misericórdia De Santos - Science Valley Research Center
Santos, São Paulo, 11075-900, Brazil
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