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Hormone implants could ease menopause symptoms for years

NCT ID NCT06343870

Symptom relief Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests small hormone implants placed under the skin to relieve menopause symptoms like hot flashes, low mood, and sexual problems. It includes 140 women with natural menopause, early ovarian failure, or menopause from cervical cancer treatment. Researchers will check hormone levels, quality of life, and safety over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
estradiol and testosterone subdermal implants
What this could lead to
If successful, this could offer a convenient, long-lasting treatment option for menopause symptoms like hot flashes and low sexual desire.
What could go wrong
This is a phase 3 trial, but it is still relatively small (140 participants) and results may not apply to all women. Hormone therapy carries risks like blood clots, 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

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

18 to 60 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cervical cancer hypogonadism hypogonadism, male premature menopause

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Estrogen deficiency Menopause Testosterone deficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    RECRUITING

    São Paulo, São Paulo, 05401-000, Brazil

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