Sexual Effects of Transdermal or Vaginal Testosterone

University of Sao Paulo General Hospital

Status and phase: Active, not recruiting; Phase 2

Conditions: Testosterone Deficiency; Testosterone Adverse Reaction; Female Sexual Dysfunction; Postmenopausal Symptoms

Treatments: Drug: Transdermal testosterone; Device: Placebo group; Drug: Vaginal testosterone gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06794346

2907493

Details and patient eligibility

About

The aim of the study is to elucidate the role of testosterone treatment in postmenopausal women's sexual function and their therapeutic safety.

Full 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;

Enrollment: 132 estimated patients

Sex: Female

Ages: 38 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 3 patient groups, including a placebo group

Transdermal testosterone

Experimental group

Description:

In this group women will receive vaginal placebo cream and transdermal testosterone cream (300mcg)

Treatment:

Drug: Transdermal testosterone

Vaginal testosterone cream

Experimental group

Description:

In this group women will receive vaginal testosterone cream (300 mcg) and transdermal placebo cream

Treatment:

Drug: Vaginal testosterone gel

Placebo

Placebo Comparator group

Description:

In this group women will receive vaginal placebo cream e transdermal placebo cream

Treatment:

Device: Placebo group