Sexual Effects of Transdermal or Vaginal Testosterone

January 20, 2025 updated by: Jose Maria Soares Junior, University of Sao Paulo General Hospital

Effects of Vaginal or Transdermal Testosterone on Sexual Response and Climacteric Symptoms in Postmenopausal Women

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04002021
        • Flavia Fairbanks

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transdermal testosterone
In this group women will receive vaginal placebo cream and transdermal testosterone cream (300mcg)
Drug: Transdermal testosterone
women will receive 300mcg of transdermal testosterone in cream daily for six months
Other Names:
  • transdermal group
Experimental: Vaginal testosterone cream
In this group women will receive vaginal testosterone cream (300 mcg) and transdermal placebo cream
Drug: Vaginal testosterone gel
women will receive 300mcg of vaginal gel testosterone daily for six months
Other Names:
  • vaginal group
Placebo Comparator: Placebo
In this group women will receive vaginal placebo cream e transdermal placebo cream
Device: Placebo group
women will receive both vaginal gel and transdermal cream placebo for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in sexual disorders measured by FSFI (Female Sexual Function index) after 12 and 24 weeks of treatment
Time Frame: 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.
From enrollment to the end of treatment at 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in hypoactive desire and arousal measured by FSFI ( Female Sexual Function Index) after 12 and 24 weeks of treatment
Time Frame: 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.
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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.
From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Chair: Edmund C Baracat, Head, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

October 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2907493

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The study is still in progress and we don´t have the preliminary data available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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