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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
To evaluate the prevalence of different sexual dysfunctions in postmenopausal patients, classifying them according to Diagnostic and Statistical Manual of Mental Disorders 5th (2013):
To evaluate the response on climacteric symptoms after testosterone replacement using the Kupperman Menopausal Index;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transdermal testosterone | Experimental | In this group women will receive vaginal placebo cream and transdermal testosterone cream (300mcg) |
|
| Vaginal testosterone cream | Experimental | In this group women will receive vaginal testosterone cream (300 mcg) and transdermal placebo cream |
|
| Placebo | Placebo Comparator | In this group women will receive vaginal placebo cream e transdermal placebo cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal testosterone | Drug | women will receive 300mcg of transdermal testosterone in cream daily for six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
disabling diseases;
use of medicines that inhibit sexual desire;
inability to answer the questionnaires;
altered routine exams and comorbidities:
Diagnosis after psychological screening for moderate to severe anxiety / depression.
Only female self-identified gender are accepted for the study
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| Name | Affiliation | Role |
|---|---|---|
| Edmund C Baracat, Head | University of Sao Paulo General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flavia Fairbanks | São Paulo | São Paulo | 04002021 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14961047 | Background | Abdo CH, Oliveira WM Jr, Moreira ED Jr, Fittipaldi JA. Prevalence of sexual dysfunctions and correlated conditions in a sample of Brazilian women--results of the Brazilian study on sexual behavior (BSSB). Int J Impot Res. 2004 Apr;16(2):160-6. doi: 10.1038/sj.ijir.3901198. | |
| 19803917 | Background | Alexander JL, Dennerstein L, Burger H, Graziottin A. Testosterone and libido in surgically and naturally menopausal women. Womens Health (Lond). 2006 May;2(3):459-77. doi: 10.2217/17455057.2.3.459. |
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The study is still in progress and we don´t have the preliminary data available.
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This is a phase 2, randomized, double-blind, parallel-group clinical trial with a 24-week follow-up of patients using testosterone 300 mcg (transdermal or vaginal cream) versus placebo.
The patients will be distributed as follows:
Group A : will receive transdermal testosterone (300 mcg) and vaginal placebo for 24 weeks Group B : will receive transdermal placebo and vaginal testosterone (300 mcg) for 24 weeks Group C: will receive transdermal and vaginal placebo for 24 weeks
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The patients are randomized into 3 different groups and given a number 1 to 132 to identify wich arm is she in.
| Vaginal testosterone gel | Drug | women will receive 300mcg of vaginal gel testosterone daily for six months |
|
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| Placebo group | Device | women will receive both vaginal gel and transdermal cream placebo for six months |
|
| 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 | 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 | 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 | 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:
| From enrollment to the end of treatment at 24 weeks |