Implant vs. gel: which hormone delivery wins for menopause?
NCT ID NCT07754630
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial tests two ways of delivering the hormone estradiol to women going through menopause: a small implant placed under the skin versus a daily gel applied to the skin. The study will measure hormone levels in the blood and track how well each method eases menopause symptoms like hot flashes. Fifty women aged 41 to 59 with low estrogen will be randomly assigned to one of the two treatments and followed for six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- estradiol (as a subcutaneous implant or transdermal gel)
- What this could lead to
- If successful, this could help doctors choose the best way to deliver hormone therapy for menopause, potentially improving symptom relief and quality of life.
- What could go wrong
- This is a small, early-stage trial, so results may not apply to all women. Hormone therapy carries risks, including blood clots and breast cancer, which the study will monitor.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
50 people
The number who actually took part.
- Started
-
Feb 2025
- Expected to finish
-
Oct 2027
An estimate. End dates often move.
- Lead sponsor
-
A research network
The lead sponsor is a research network or cooperative group.
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
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: Women aged 41 to 59 years with climacteric symptoms, weighing 50 to 90 kg, with a BMI of 18.5 to 34.9 kg/m². Hysterectomy (with or without oophorectomy). Hypoestrogenism defined by a total serum estradiol concentration ≤ 50 pg/mL and a serum FSH concentration ≥ 25 mIU/mL. Absence of signs, symptoms, or clinical findings suggestive of breast cancer, as evidenced by a mammography report (for women \> 40 years of age) dated within the last 12 months showing BI-RADS 1 or BI-RADS 2 classification. Agreement not to use other hormones (estrogens, androgens, and/or progestogens) or contraceptives in any pharmaceutical form during the study. Exclusion Criteria: Contraindications to the use of menopausal hormone therapy: vaginal bleeding of unknown cause; personal history of hormone-dependent neoplasia, including breast cancer or breast cancer precursor lesions; liver disease; porphyria; personal history of coronary artery disease, cerebrovascular disease, or venous thromboembolism; systemic lupus erythematosus with high thromboembolic risk; and meningioma. Comorbidities associated with increased cardiovascular risk: smoking, uncontrolled diabetes, dyslipidemia, and uncontrolled hypertension. Severe chronic disorders, including metastatic malignancies, end-stage renal disease (with or without dialysis), clinically unstable heart disease, or any other disorder that, in the investigator's opinion, excludes the participant from the study. Immunocompromise or suspected/confirmed diagnosis of immunodeficiency based on history and/or physical or laboratory examination. Active liver disease or dysfunction. Benign or malignant liver tumors. Clinical diagnosis of polycystic ovary syndrome. Use of other hormones (estrogens, androgens, and/or progestogens) in any pharmaceutical form within the last month. Use of contraceptives. Current use of medications that alter cytochrome P450 activity and estrogen metabolism. Current use of tamoxifen, aromatase inhibitors, or GnRH agonists/antagonists for cancer or any other condition. Current use of phytoestrogens. Participation in another clinical study within 30 days prior to the start of study treatment. Patients who do not complete all study stages, who do not adhere to the intervention, or who experience an intercurrent event that interferes with the study outcome. \-
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Nutrindo Ideais Research Center
Rio de Janeiro, Rio de Janeiro, 22421000, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A phone game takes on menopause brain fog