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Use of transdermal Testosterone in women with decreased sexual desire and tendency for aggressiveness: a double blind randomized clinical trial

Use of transdermal Testosterone Nanoemulsion in women with Hypoactive sexual desire and tendency for aggressiveness: a double blind randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-27cqn5
Enrollment
Unknown
Registered
2019-09-11
Start date
2018-07-05
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

Experimental group: 35 women with hypoactive sexual desire will receive transdermal biolipid-associated testosterone nanoemulsion (1 gram puff containing 300mcg / day). Control group: 35 women with hy
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 between 18 and 45 years old with regular menstrual cycles; decreased sexual desire; sexual activity present with at least one sexual event per month with actual partner; be in good general health; use of an effective contraceptive method; women over 40 years old should have a clinically acceptable mammogram in 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; antiandrogen therapy for acne or hirsutism in the last 5 years; moderate or severe acne, hirsutism, or androgenetic alopecia; participant with any hyperandrogenic syndrome; any clinical illness or severe depression, active cancer, or treatment of malignancy in the last six months; pregnancy or breastfeeding; do not come to our center for follow-up study visits;

Design outcomes

Primary

MeasureTime frame
Evaluate behavioral changes with a tendency towards aggressiveness after the intervention, determined by a change of classification in a validated questionnaire (aggressiveness tendency assessment scale) applied at the beginning and end of the study

Secondary

MeasureTime frame
To determine improvement in sexual desire after intervention, assessed by increasing of the total score of a validated questionnaire (female sexual function index) applied at the beginning and end of the study

Countries

Brazil

Contacts

Public ContactMaria Eugenia Lopes Cardoso

Universidade Federal de São Paulo - UNIFESP

mariae_clc@hotmail.com+55(11)55496174

Outcome results

None listed

Source: REBEC (via WHO ICTRP)