The aim of the study is to elucidate the role of testosterone treatment in postmenopausal women's sexual function and their therapeutic safety.
-General To evaluate the therapeutic efficacy of testosterone treatment in sexual dysfunction in postmenopausal patients. -Specifics 1. To evaluate the prevalence of different sexual dysfunctions in postmenopausal patients, classifying them according to Diagnostic and Statistical Manual of Mental Disorders 5th (2013): * Female sexual desire / arousal disorder; * Female orgasm disorder; * pelvic or genital pain / penetration disorder; 2. To evaluate the response on climacteric symptoms after testosterone replacement using the Kupperman Menopausal Index;
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
women will receive 300mcg of transdermal testosterone in cream daily for six months
women will receive 300mcg of vaginal gel testosterone daily for six months
women will receive both vaginal gel and transdermal cream placebo for six months
Flavia Fairbanks
São Paulo, São Paulo, Brazil
Changes in sexual disorders measured by FSFI (Female Sexual Function index) after 12 and 24 weeks of treatment
We expect a 40% change for better in sexual complaints for the experimental group when compared with the placebo group. We will use the FSFI questionaire (Female sexual function index): a multidimensional self-Report instrument for the assessment of female sexual function (including desire/ libido, arousal, pain/discomfort, and orgasm) translated and validated to portuguese applied on time 0, 12 weeks and 24 weeks for each patient. Cite: Pacagnella RC, Martinez EZ, Vieira EM. Cad. Saúde Pública, Rio de Janeiro; 25 (11): 2333-2344. Nov 2009.
Time frame: From enrollment to the end of treatment at 24 weeks
Changes in hypoactive desire and arousal measured by FSFI ( Female Sexual Function Index) after 12 and 24 weeks of treatment
We expect a 40% change for better in hypoactive desire and arousal complaints in the group that receive testosterone, either the transdermal or vaginal . We will use the FSFI (Female sexual function index) translated and validated to portuguese to access the desire/libido before, during and after intervention. Cite: Pacagnella RC, Martinez EZ, Vieira EM. Cad Saúde Pública, Rio de Janeiro; 25(11): 2333-2344, Nov 2009.
Time frame: From enrollment to the end of treatment at 24 weeks
Change in orgasm measured by FSFI ( Female Sexual Function Index) after 12 and 24 weeks of treatment
We expect a 40% change for better in orgasm complaints in the group that receive testosterone, either the transdermal or vaginal . We will use the FSFI (Female sexual function index) translated and validated to portuguese to access changes in orgasm before, during and after intervention. Cite: Pacagnella RC, Martinez EZ, Vieira EM. Cad Saúde Pública, Rio de Janeiro; 25(11): 2333-2344, Nov 2009
Time frame: From enrollment to the end of treatment at 24 weeks
change in genitopelvic pain measured by FSFI ( Female Sexual Function Index) after 12 and 24 weeks of treatment
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We expect a 40% change for better in pain complaints in the group that receive testosterone, either the transdermal or vaginal . We will use the FSFI (Female sexual function index) translated and validated to portuguese to access changes in orgasm before, during and after intervention. Cite: Pacagnella RC, Martinez EZ, Vieira EM. Cad Saúde Pública, Rio de Janeiro; 25(11): 2333-2344, Nov 2009
Time frame: From enrollment to the end of treatment at 24 weeks
Change in climateric symptoms measured by Blatt-Kupperman Menopausal Index questionaire after 12 and 24 weeks of treatment
We expect a 50% change for better of climateric symptoms complaints in the group that receive testosterone, either transdermal or vaginal . We will use Blatt-Kupperman menopausal índex questionnaire before, during and after the intervention. cite: 1. Kupperman et al, Menopausal Syndrome. JAMA, 171 (12): 1627-1637. Nov 1959. 2. Alder E. The Blatt-Kupperman Menopausal Index: a critique. Maturitas, 29(1): 19-24. May 1998.
Time frame: From enrollment to the end of treatment at 24 weeks