Female Sexual Dysfunction, Postmenopausal Symptoms, Testosterone Adverse Reaction, Testosterone Deficiency
Conditions
Keywords
Sexual effects of transdermal or vaginal testosterone, low sexual desire, postmenopause, transdermal testosterone, vaginal testosterone
Brief summary
The aim of the study is to elucidate the role of testosterone treatment in postmenopausal women's sexual function and their therapeutic safety.
Detailed description
-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;
Interventions
women will receive 300mcg of transdermal testosterone in cream daily for six months
DRUGVaginal testosterone gel
women will receive 300mcg of vaginal gel testosterone daily for six months
DEVICEPlacebo group
women will receive both vaginal gel and transdermal cream placebo for six months
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patients are randomized into 3 different groups and given a number 1 to 132 to identify wich arm is she in.
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
38 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sexual disorders measured by FSFI (Female Sexual Function index) after 12 and 24 weeks of treatment | From enrollment to the end of treatment at 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hypoactive desire and arousal measured by FSFI ( Female Sexual Function Index) after 12 and 24 weeks of treatment | From enrollment to the end of treatment at 24 weeks | 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. |
| Change in orgasm measured by FSFI ( Female Sexual Function Index) after 12 and 24 weeks of treatment | From enrollment to the end of treatment at 24 weeks | 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 |
| change in genitopelvic pain measured by FSFI ( Female Sexual Function Index) after 12 and 24 weeks of treatment | From enrollment to the end of treatment at 24 weeks | 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 |
| Change in climateric symptoms measured by Blatt-Kupperman Menopausal Index questionaire after 12 and 24 weeks of treatment | From enrollment to the end of treatment at 24 weeks | 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. |
Countries
Brazil
Outcome results
None listed