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Use of testosterone cream applied to skin in women with hypoactive sexual desire and quality of life

Transdermal use of testosterone nanoemulsion in women with desire hypoactive sex disorder and quality of life: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7sx64c
Enrollment
Unknown
Registered
2019-10-31
Start date
2018-04-25
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lack or loss of sexual desire

Interventions

This is a randomized clinical trial involving women between 18 and 45 years old, complaining about low sexual desire. They will be randomized into two groups, with 25 patients in each group, and will
Drug

Sponsors

Universidade Federal de São Paulo - UNIFESP
Lead Sponsor
Universidade Federal de São Paulo - UNIFESP
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women over the age of 18 and the maximum age of 45 who are menstruating physiologically; decrease in sexual desire; sexual activity present with at least one sexual event per month and with current partner; be in good general health; being on contraceptive method (MAC); women over 40 years of age should have a clinically acceptable mammogram within the last 2 years;

Exclusion criteria

Exclusion criteria: Sexual dysfunction caused by another medical condition; body mass index (BMI) below 18 kg / m2 or above 35 kg / m2; undiagnosed genital bleeding; androgen therapy in the last 6 months (testosterone implant, testosterone transdermal cream, oral testosterone or injectable testosterone); antiandrogen therapy for acne or hirsutism in the last 5 years; moderate or severe acne, hirsutism, and androgenetic alopecia; participant with any hyperandrogenic syndrome; any clinical illness or severe depression, active cancer, or treatment of malignancy within the last six months; pregnancy or nursing; not attending our center for follow-up study visits

Design outcomes

Primary

MeasureTime frame
Evaluate the improvement in quality of life after transdermal testosterone use in women with hypoactive sexual desire through a shortened quality of life questionnaire that will be applied before and after the use of a placebo or testosterone gel;Evaluate whether transdermal testosterone use in women with hypoactive sexual desire improved sexual complaints through a specific sexuality questionnaire (FSFI) applied before and after the transdermal gel;Evaluate in patients undergoing treatment with a history of depression whether there was improvement in depressive symptoms after medication use through the Beck questionnaire applied before and after the transdermal gel

Secondary

MeasureTime frame
Evaluate possible side effects of medications perceived in outpatient medical consultation after gel use

Countries

Brazil

Contacts

Public ContactMarcela Margato

Universidade Federal de São Paulo - UNIFESP

mahmargato@gmail.com+551155496174

Outcome results

None listed

Source: REBEC (via WHO ICTRP)