Health TrialsbyHealthPanel

Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

ConditionsMenopauseTestosterone DeficiencyEstrogen Deficiency
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorUniversity of Sao Paulo General Hospital

About this trial

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. Pharmacokinetic, biochemical, metabolic, thromboembolic and hormonal data will be evaluated, as well as the effects on quality of life, menopausal symptoms and sexual function after treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

disabling illnesses;

use of medications that inhibit sexual desire;

inability to answer the questionnaires;

Severe hypertension with Blood Pressure measurement > 160 x 90 mmHg in two measurements

Trial design

Design model

Parallel

Treatments tested in this trial

  • testosterone pellet (100 mg)

    Drug

    Intervention arm: Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)

  • Placebo

    Drug

    Pellet of cholesterol (placebo)

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: TestosteroneActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms

evaluate concentration in serum of luteinizing hormone, follicle stimulating hormone, estradiol, estrone, total testosterone and sex hormone-binding globulin.

Time frame
6 months

Secondary outcomes

1

Evaluate response in quality of life and sexual function

Evaluate response on vulvovaginal atrophy and genitourinary syndrome of menopause, hormonal and metabolic effects on climacteric symptoms, using the Kupperman Menopausal Index; response in quality of life and sexual function; hormonal and metabolic effects;

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Source ClinicalTrials.gov
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