Clinical trial NCT06794346: Sexual Effects of Transdermal or Vaginal Testosterone
Official title: Effects of Vaginal or Transdermal Testosterone on Sexual Response and Climacteric Symptoms in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Female Sexual Dysfunction
Postmenopausal Symptoms
Testosterone Deficiency
Testosterone Adverse Reaction
Keywords: Sexual effects of transdermal or vaginal testosterone
low sexual desire
postmenopause
transdermal testosterone
vaginal testosterone
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 132
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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;

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in sexual disorders measured by FSFI (Female Sexual Function index) after 12 and 24 weeks of treatment
timeFrame: From enrollment to the end of treatment at 24 weeks
Secondary outcomes:
measure: Changes in hypoactive desire and arousal measured by FSFI ( Female Sexual Function Index) after 12 and 24 weeks of treatment
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Change in orgasm measured by FSFI ( Female Sexual Function Index) after 12 and 24 weeks of treatment
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: change in genitopelvic pain measured by FSFI ( Female Sexual Function Index) after 12 and 24 weeks of treatment
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Change in climateric symptoms measured by Blatt-Kupperman Menopausal Index questionaire after 12 and 24 weeks of treatment
timeFrame: From enrollment to the end of treatment at 24 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Flavia Fairbanks
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Edmund C Baracat, Head
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.