Subdermal estradiol and testosterone implants for relieving menopausal symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial will enroll 140 women divided into three groups: natural postmenopausal women with symptoms, women with premature ovarian failure, and women with surgical menopause after hysterectomy for cervical cancer. Participants will receive subdermal bioabsorbable estradiol and a 100 mg testosterone pellet or placebo and be followed for six months with visits at baseline, 1, 3, and 6 months. The protocol includes intensive pharmacokinetic sampling shortly after implant insertion and monthly, plus hormone, biochemical, metabolic, thromboembolic and imaging tests and standardized questionnaires on quality of life, menopausal symptoms, and sexual function. Clinical and laboratory outcomes will be compared over time using nonparametric tests and chi-square analysis for categorical improvements.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Edmund Baracat, PhD — Instituto do Coracao
• Study coordinator: André Malavasi, PhD
• Email: drandreluiz@usp.br
• Phone: 55 11 981348231

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.