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Hormone pellet study tracks estrogen levels for six months

NCT ID NCT06136208

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Dec 2023

Finished

Jul 2025

Lead sponsor

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

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Irmandade Da Santa Casa De Misericórdia De Santos - Science Valley Research Center

    Santos, São Paulo, 11075-900, Brazil

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