Sexual Effects of Transdermal or Vaginal Testosterone

Phase 2

Active, not recruiting

• Conditions: Female Sexual Dysfunction; Postmenopausal Symptoms; Testosterone Deficiency; Testosterone Adverse Reaction
• Interventions: Drug: Transdermal testosterone; Drug: Vaginal testosterone gel; Device: Placebo group

• Registration Number: NCT06794346
• Lead Sponsor: University of Sao Paulo General Hospital

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;

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2022-03-18
• Status Verified: 2024-04
• Primary Completion: 2024-10-01
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transdermal testosterone	Transdermal testosterone	In this group women will receive vaginal placebo cream and transdermal testosterone cream (300mcg)
Vaginal testosterone cream	Vaginal testosterone gel	In this group women will receive vaginal testosterone cream (300 mcg) and transdermal placebo cream
Placebo	Placebo group	In this group women will receive vaginal placebo cream e transdermal placebo cream

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Flavia Fairbanks; 🇧🇷 São Paulo, SP, Brazil