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 range

38 Years – 60 Years

Sex

FEMALE

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT06794346

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Female Sexual Dysfunction trials