Sexual Effects of Transdermal or Vaginal Testosterone

NCT06794346 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2907493
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

Transdermal testosterone

EXPERIMENTAL

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

Drug: Transdermal testosterone

Vaginal testosterone cream

EXPERIMENTAL

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

Drug: Vaginal testosterone gel

Placebo

PLACEBO COMPARATOR

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

Device: Placebo group

Interventions

Transdermal testosterone DRUG

women will receive 300mcg of transdermal testosterone in cream daily for six months

Also known as: transdermal group

Transdermal testosterone

Vaginal testosterone gel DRUG

women will receive 300mcg of vaginal gel testosterone daily for six months

Also known as: vaginal group

Vaginal testosterone cream

Placebo group DEVICE

women will receive both vaginal gel and transdermal cream placebo for six months

Placebo

Eligibility Criteria

• Age: 38 Years - 60 Years
• Gender Eligibility Details: Only female self-identified gender are accepted for the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Flavia Fairbanks

São Paulo, São Paulo, 04002021, Brazil

Location

Related Publications (2)

• 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.

  PMID: 14961047 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.

  PMID: 19803917 BACKGROUND

Study Officials

• Edmund C Baracat, Head

  University of Sao Paulo General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients are randomized into 3 different groups and given a number 1 to 132 to identify wich arm is she in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: January 27, 2025
• Study Start: October 1, 2020
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2024-04

Locations

BR (1)