Female Sexual DysfunctionPhase 2NCT06794346
Sexual Effects of Transdermal or Vaginal Testosterone
A Phase 2 study testing Transdermal testosterone and Vaginal testosterone gel in people with Female Sexual Dysfunction and Postmenopausal Symptoms, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The aim of the study is to elucidate the role of testosterone treatment in postmenopausal women's sexual function and their therapeutic safety. Read more about this study
- Who is it for?
- Ages 38 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Sexual Dysfunction, Postmenopausal Symptoms, Testosterone Deficiency
- What is being tested?
- Transdermal testosterone and Vaginal testosterone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2020to 1 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
-General To evaluate the therapeutic efficacy of testosterone treatment in sexual dysfunction in postmenopausal patients.
-Specifics
- 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;
- To evaluate the response on climacteric symptoms after testosterone replacement using the Kupperman Menopausal Index;
- Conditions
- Female Sexual Dysfunction, Postmenopausal Symptoms, Testosterone Deficiency, Testosterone Adverse Reaction
- Being tested
- Transdermal testosterone, Vaginal testosterone gel, Placebo group
- Keywords
- Sexual effects of transdermal or vaginal testosterone, low sexual desire, postmenopause, transdermal testosterone, vaginal testosterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal testosteroneDrug
Also called transdermal group
women will receive 300mcg of transdermal testosterone in cream daily for six months
Vaginal testosterone gelDrug
Also called vaginal group
women will receive 300mcg of vaginal gel testosterone daily for six months
Placebo groupDevice
women will receive both vaginal gel and transdermal cream placebo for six months
| Study group | Role | What they receive |
|---|---|---|
| Transdermal testosterone | Experimental | In this group women will receive vaginal placebo cream and transdermal testosterone cream (300mcg) Receives: Drug: Transdermal testosterone |
| Vaginal testosterone cream | Experimental | In this group women will receive vaginal testosterone cream (300 mcg) and transdermal placebo cream Receives: Drug: Vaginal testosterone gel |
| Placebo | Placebo comparator | In this group women will receive vaginal placebo cream e transdermal placebo cream Receives: Device: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
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
Measured: 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
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:
- Kupperman et al, Menopausal Syndrome. JAMA, 171 (12): 1627-1637. Nov 1959.
- Alder E. The Blatt-Kupperman Menopausal Index: a critique. Maturitas, 29(1): 19-24. May 1998.
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Oct 2020
- Primary completion1 Oct 2024
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Maria Soares Junior, University of Sao Paulo General Hospital
- Investigators
- Edmund C Baracat, Head, Study chair, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794346
- Sponsor's protocol ID
- 2907493
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study is still in progress and we don´t have the preliminary data available.
Publications
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.
PubMed 14961047Alexander 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.
PubMed 19803917
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vaginal or Transdermal Testosterone on Sexual Response and Climacteric Symptoms in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06794346
- Acronym / sponsor ID
- 2907493
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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;
- To evaluate the response on climacteric symptoms after testosterone replacement using the Kupperman Menopausal Index;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Transdermal testosterone | Experimental | Drug: Transdermal testosteroneIn this group women will receive vaginal placebo cream and transdermal testosterone cream (300mcg) |
| Vaginal testosterone cream | Experimental | Drug: Vaginal testosterone gelIn this group women will receive vaginal testosterone cream (300 mcg) and transdermal placebo cream |
| Placebo | Placebo comparator | Device: Placebo groupIn this group women will receive vaginal placebo cream e transdermal placebo cream |
Who may qualify
- Ages
- 38 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (15 listed)
- disabling diseases;
- use of medicines that inhibit sexual desire;
- inability to answer the questionnaires;
- altered routine exams and comorbidities:
- Diagnosis after psychological screening for moderate to severe anxiety / depression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal testosteroneAlso: transdermal groupwomen will receive 300mcg of transdermal testosterone in cream daily for six months | Drug | Transdermal testosterone |
| Vaginal testosterone gelAlso: vaginal groupwomen will receive 300mcg of vaginal gel testosterone daily for six months | Drug | Vaginal testosterone cream |
| Placebo groupwomen will receive both vaginal gel and transdermal cream placebo for six months | Device | Placebo |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Background: PubMed 14961047Abdo 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.
- Background: PubMed 19803917Alexander 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.
- Individual participant dataSharing planned: Undecided. The study is still in progress and we don´t have the preliminary data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmund C Baracat, Head study chair
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transdermal testosterone and Vaginal testosterone gel in people with Female Sexual Dysfunction and Postmenopausal Symptoms, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06794346, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.