Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)
140 patients around the world
Available in Brazil
The clinical study will be carried out on 140 women, who will be divided into three
groups: (1) postmenopausal women with menopausal and sexual symptoms (n=60); (2) women
with premature ovarian failure (n=40); (3) women with cervical cancer undergoing
abdominal hysterectomy with bilateral adnexectomy, with menopausal and sexual symptoms
(n=40).
All participants will answer questionnaires to assess quality of life, menopausal
symptoms and sexual function. All participants will undergo general physical and
gynecological examinations, as well as hormonal, biochemical, thromboembolic and imaging
tests.
The study will last six months. The included participants will undergo the following
visits: inclusion (post-selection) and 1, 3 and 6 months after implant insertion. For the
pharmacokinetic study, blood samples will be collected at the following periods:
inclusion (before implant placement) and after 1h, 2h, 3h, 6h and 12h; one week, two
weeks and one month after placement, and then monthly until six months after implant
insertion, to evaluate serum levels of Luteinizing hormone, Follicle stimulating hormone,
estradiol, estrone, total testosterone and sex hormone-binding globulin.
Clinical, biochemical, hormonal and therapeutic parameters will be evaluated before
placement (inclusion) and after 3 and 6 months. The Mann Whitney test will be applied to
evaluate differences between measurements and the chi-square test will be applied to
analyze the proportions of improvement between groups before and after treatment.
University of Sao Paulo General Hospital
1Research sites
140Patients around the world
This study is for people with
Menopause
Requirements for the patient
To 60 Years
Female
Medical requirements
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.
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.