Sexual Effects of Transdermal or Vaginal Testosterone (NCT06794346) | Clinical Trial Compass
UnknownPhase 2
Sexual Effects of Transdermal or Vaginal Testosterone
Brazil132 participantsStarted 2020-10-01
Plain-language summary
The aim of the study is to elucidate the role of testosterone treatment in postmenopausal women's sexual function and their therapeutic safety.
Who can participate
Age range38 Years – 60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Brazilian women with menopause time from 2 to 6 years;
* active sex life;
* absence of severe depression and anxiety, as evidenced by the Beck (depression specific) and Beck (anxiety specific) questionnaires;
Exclusion Criteria:
* disabling diseases;
* use of medicines that inhibit sexual desire;
* inability to answer the questionnaires;
* altered routine exams and comorbidities:
* Severe hypertension with Blood Pressure measurement \> 160 mmHg (maximum) or/and 90 mmHg (minimum) in two measurements
* clinical or subclinical thyroid dysfunction: thyroid-stimulating hormone over 4
* triglyceride dyslipidemia\> 400
* presence of occult blood in stool
* hyperprolactinemia
* fasting blood glucose\> 100
* presence of osteopenia or osteoporosis
* BIRADS score 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 for moderate to severe anxiety / depression.
What they're measuring
1
Changes in sexual disorders measured by FSFI (Female Sexual Function index) after 12 and 24 weeks of treatment
Timeframe: From enrollment to the end of treatment at 24 weeks