What this trial studies
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. Parenteral administration of estradiol and testosterone could be effective to treat symptoms secondary to estrogen and androgen deficiencies and minimize these adverse events. This study evaluates the efficiency of subdermal implant-bioabsorbable use in women with menopausal symptoms associated with secondary estrogen and androgen deficiencies in women with natural menopause, premature ovarian failure or surgical menopause due to cervical cancer.
Conditions in scope
- Menopause
- Testosterone Deficiency
- Estrogen Deficiency
Interventions
- testosterone pellet (100 mg) (Drug) — Intervention arm: Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)
- Placebo (Drug) — Pellet of cholesterol (placebo)
Who can join
Women only · Ages 18 Years to 60 Years
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
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| São Paulo | São Paulo | Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: PHASE3
- Start date: 2025-12-18
- Primary completion: 2026-08-18
- Last update posted: 2025-12-29
- First posted: 2024-04-03
Sponsor & contact
Lead sponsor: University of Sao Paulo General Hospital (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms (6 months)
evaluate concentration in serum of luteinizing hormone, follicle stimulating hormone, estradiol, estrone, total testosterone and sex hormone-binding globulin.
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06343870 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.