Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)
Recruiting
Phase 3
Interventional Study
Menopause
Testosterone Deficiency
Estrogen Deficiency
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 140 (estimated)
- Sponsor
- University of Sao Paulo General Hospital · Other
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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 eval…
Trial Locations
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Eligibility Criteria
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, confir…
Contacts
Edmund Baracat, PhD
55 11 98149-6253
CONTACT