Hypoactive Sexual Desire DisorderTESTOFSDNCT04336891
Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
An observational study of Hypoactive Sexual Desire Disorder and Vulvovaginal Disease, run by University of Florence at 1 site in Italy.
Trial summary
The regulation of clitoral vascularization by sex steroids is still under-investigated. We aimed to explore the effects of 6 months transdermal Testosterone (T) therapy on clitoral color Doppler ultrasound (CDU) parameters in pre- and postmenopausal women with female sexual dysfunction (FSD). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder, Vulvovaginal Disease, Menopause Related Conditions
- What is being tested?
- Testosterone gel, Estradiol ovules and Moisturizer
- How many people
- 81 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2019to 31 Mar 2020
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pre- and postmenopausal women who attended our outpatient clinic at Andrology, Women's Endocrinology and Gender Incongruence Unit, University of Florence (Florence, Italy) for sexual concerns.
Who may be able to join
- being heterosexual.
Who cannot join
- history of drug or alcohol abuse
- a diagnosis of uncontrolled or unstable mental or organic disease.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Andrology, Women's Endocrinology and Gender Incongruence Unit, University of Florence, Azienda Ospedaliero-Universitaria Careggi
Florence, 50136
About this study
Official title: Pilot Retrospective Study on the Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
The regulation of clitoral vascularization by sex steroids is still under-investigated. We aimed to explore the effects of 6 months transdermal Testosterone (T) therapy on clitoral color Doppler ultrasound (CDU) parameters in pre- and postmenopausal women with female sexual dysfunction (FSD). In order to do that, we retrospectively recruited n=81 women with FSD, divided into 4 groups according to different treatments followed as per clinical practice, for 6 months: transdermal systemic 2% T gel; local estradiol ovules; local non-hormonal moisturizers; transdermal T plus local estrogens.
Our main hypothesis is that systemic T treatment is able to positively modulate clitoral blood flow in basal conditions, specifically to increase clitoral artery Peak systolic velocity (PSV).
Read the detailed description
Strong clinical evidence supports the use of transdermal systemic testosterone (T) treatment for Hypoactive Sexual Desire Disorder (HSDD) in menopausal women. According to preclinical studies, T is necessary to maintain the functional machinery underlying clitoral arousal response. In hypogonadal men with erectile dysfunction, T replacement therapy is able to improve penile vasodilation as assessed by using color Doppler ultrasound (CDU). On the other hand, the regulation of clitoral vascularization by sex steroids is still under-investigated.
We aimed to explore the effects of 6 months T therapy on clitoral CDU parameters and sexual function in pre- and postmenopausal women with female sexual dysfunction (FSD).
Adult heterosexual women attending our clinic for sexual concerns were retrospectively recruited. A subgroup of sexually active patients with FSD (n=81) was divided into 4 different groups according to different treatments followed as per clinical practice: women with Hypoactive Sexual Desire Disorder (HSDD) treated with off-label transdermal 2% T gel once daily (300 mcg T per day, n=23); women with dyspareunia due to moderate to severe vulvovaginal atrophy (VVA), treated with local estrogens (estradiol ovules) taken daily for 2 weeks and afterwards twice a week (n=12); women with dyspareunia due to mild to moderate VVA, treated with non-hormonal moisturizers every 2-3 days (n=37); women with HSDD reporting also significant dyspareunia due to moderate to severe VVA, treated with combined therapy (transdermal T and local estrogens) (n=9). Patients underwent physical, laboratory, uterine and genital (clitoral and uterine arteries) CDU examinations, and completed the Female Sexual Function Index (FSFI). at baseline and after 6 months.
Our main hypothesis is that systemic T treatment is able to positively modulate clitoral blood flow in basal conditions, specifically to increase clitoral artery Peak systolic velocity (PSV).
- Conditions
- Hypoactive Sexual Desire Disorder, Vulvovaginal Disease, Menopause Related Conditions, Dyspareunia (Female Excluding Psychogenic), Hypoestrogenism, Arousal Disorders, Sexual
- Being tested
- Testosterone gel, Estradiol ovules, Moisturizer, Testosterone gel + Estradiol ovules
- Keywords
- testosterone, female sexual dysfunction, genital vascularization, clitoris, dyspareunia
- Medical subject headings
- Sexual Dysfunctions, Psychological, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gelDrug
Transdermal 2% T gel applied once daily to the thighs or lower abdominal/pubic area (300 mcg T per day) for 6 months
Estradiol ovulesDrug
Intravaginal estradiol ovules taken daily for 2 weeks and afterwards twice a week, for 6 months
MoisturizerDrug
Local non-hormonal moisturizers applied regularly every 2-3 days and lubricants as needed
Testosterone gel + Estradiol ovulesDrug
Also called Estradiol
Transdermal 2% T gel applied once daily to the thighs or lower abdominal/pubic area (300 mcg T per day), plus Intravaginal estradiol ovules taken daily for 2 weeks and afterwards twice a week, for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Hypoactive Sexual Desire Disorder | Women with Hypoactive Sexual Desire Disorder (HSDD, n=23) Receives: Drug: Testosterone gel | |
| Moderate to severe VVA | Women with dyspareunia due to moderate to severe vulvovaginal atrophy (VVA) (n=12) Receives: Drug: Estradiol ovules | |
| Mild to moderate VVA | Women with dyspareunia due to mild to moderate VVA (n=37) Receives: Drug: Moisturizer | |
| HSDD + VVA | Women with HSDD reporting also significant dyspareunia due to moderate to severe VVA (n=9). Receives: Drug: Testosterone gel + Estradiol ovules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of clitoral artery peak systolic velocity (PSV) in women treated with testosterone gel
parameter evaluated at clitoral color Doppler ultrasound
Measured: 6 months
Changes of clitoral artery pulsatility index (PI) in women treated with testosterone gel
parameter evaluated at clitoral color Doppler ultrasound
Measured: 6 months
Changes of clitoral artery acceleration (ACC) in women treated with testosterone gel
parameter evaluated at clitoral color Doppler ultrasound
Measured: 6 months
Secondary outcomes (3)
Difference in changes of clitoral artery PSV among the 4 intervention groups
Measured: 6 months
Difference in changes of clitoral artery PI among the 4 intervention groups
Measured: 6 months
Difference in changes of clitoral artery ACC among the 4 intervention groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start20 Mar 2019
- Primary completion31 Dec 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypoactive Sexual Desire DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Vignozzi, MD, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336891
- Sponsor's protocol ID
- FEMENDO1
- Other IDs
- 14457_oss
- Acronym
- TESTOFSD
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scavello I, Maseroli E, Di Stasi V, Cipriani S, Verde N, Magini A, Maggi M, Vignozzi L. Nomegestrol acetate/17beta-estradiol does not negatively alter the vascular resistance of clitoral arteries: a prospective, exploratory study. Int J Impot Res. 2020 Mar;32(2):239-247. doi: 10.1038/s41443-019-0162-7. Epub 2019 Jul 1.
PubMed 31263248Maseroli E, Scavello I, Vignozzi L. Cardiometabolic Risk and Female Sexuality-Part II. Understanding (and Overcoming) Gender Differences: The Key Role of an Adequate Methodological Approach. Sex Med Rev. 2018 Oct;6(4):525-534. doi: 10.1016/j.sxmr.2018.03.004. Epub 2018 Apr 13.
PubMed 29661689Davis SR, Baber R, Panay N, Bitzer J, Perez SC, Islam RM, Kaunitz AM, Kingsberg SA, Lambrinoudaki I, Liu J, Parish SJ, Pinkerton J, Rymer J, Simon JA, Vignozzi L, Wierman ME. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4660-4666. doi: 10.1210/jc.2019-01603.
PubMed 31498871Cipriani S, Maseroli E, Di Stasi V, Scavello I, Todisco T, Rastrelli G, Fambrini M, Sorbi F, Petraglia F, Jannini EA, Maggi M, Vignozzi L. Effects of testosterone treatment on clitoral haemodynamics in women with sexual dysfunction. J Endocrinol Invest. 2021 Dec;44(12):2765-2776. doi: 10.1007/s40618-021-01598-1. Epub 2021 Jun 12.
PubMed 34118018
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Retrospective Study on the Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
- ClinicalTrials.gov ID
- NCT04336891
- Acronym / sponsor ID
- TESTOFSD / FEMENDO1
- Conditions
- Hypoactive Sexual Desire Disorder, Vulvovaginal Disease, Menopause Related Conditions, Dyspareunia (Female Excluding Psychogenic), Hypoestrogenism, Arousal Disorders, Sexual
- Keywords
- testosterone, female sexual dysfunction, genital vascularization, clitoris, dyspareunia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 7 Apr 2020 (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 regulation of clitoral vascularization by sex steroids is still under-investigated. We aimed to explore the effects of 6 months transdermal Testosterone (T) therapy on clitoral color Doppler ultrasound (CDU) parameters in pre- and postmenopausal women with female sexual dysfunction (FSD). In order to do that, we retrospectively recruited n=81 women with FSD, divided into 4 groups according to different treatments followed as per clinical practice, for 6 months: transdermal systemic 2% T gel; local estradiol ovules; local non-hormonal moisturizers; transdermal T plus local estrogens.
Our main hypothesis is that systemic T treatment is able to positively modulate clitoral blood flow in basal conditions, specifically to increase clitoral artery Peak systolic velocity (PSV).
Detailed description
Strong clinical evidence supports the use of transdermal systemic testosterone (T) treatment for Hypoactive Sexual Desire Disorder (HSDD) in menopausal women. According to preclinical studies, T is necessary to maintain the functional machinery underlying clitoral arousal response. In hypogonadal men with erectile dysfunction, T replacement therapy is able to improve penile vasodilation as assessed by using color Doppler ultrasound (CDU). On the other hand, the regulation of clitoral vascularization by sex steroids is still under-investigated.
We aimed to explore the effects of 6 months T therapy on clitoral CDU parameters and sexual function in pre- and postmenopausal women with female sexual dysfunction (FSD).
Adult heterosexual women attending our clinic for sexual concerns were retrospectively recruited. A subgroup of sexually active patients with FSD (n=81) was divided into 4 different groups according to different treatments followed as per clinical practice: women with Hypoactive Sexual Desire Disorder (HSDD) treated with off-label transdermal 2% T gel once daily (300 mcg T per day, n=23); women with dyspareunia due to moderate to severe vulvovaginal atrophy (VVA), treated with local estrogens (estradiol ovules) taken daily for 2 weeks and afterwards twice a week (n=12); women with dyspareunia due to mild to moderate VVA, treated with non-hormonal moisturizers every 2-3 days (n=37); women with HSDD reporting also significant dyspareunia due to moderate to severe VVA, treated with combined therapy (transdermal T and local estrogens) (n=9). Patients underwent physical, laboratory, uterine and genital (clitoral and uterine arteries) CDU examinations, and completed the Female Sexual Function Index (FSFI). at baseline and after 6 months.
Our main hypothesis is that systemic T treatment is able to positively modulate clitoral blood flow in basal conditions, specifically to increase clitoral artery Peak systolic velocity (PSV).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypoactive Sexual Desire Disorder | – | Drug: Testosterone gelWomen with Hypoactive Sexual Desire Disorder (HSDD, n=23) |
| Moderate to severe VVA | – | Drug: Estradiol ovulesWomen with dyspareunia due to moderate to severe vulvovaginal atrophy (VVA) (n=12) |
| Mild to moderate VVA | – | Drug: MoisturizerWomen with dyspareunia due to mild to moderate VVA (n=37) |
| HSDD + VVA | – | Drug: Testosterone gel + Estradiol ovulesWomen with HSDD reporting also significant dyspareunia due to moderate to severe VVA (n=9). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre- and postmenopausal women who attended our outpatient clinic at Andrology, Women's Endocrinology and Gender Incongruence Unit, University of Florence (Florence, Italy) for sexual concerns.
Key inclusion criteria (1 listed)
- being heterosexual.
Key exclusion criteria (2 listed)
- history of drug or alcohol abuse
- a diagnosis of uncontrolled or unstable mental or organic disease.
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 |
|---|---|---|
| Testosterone gelTransdermal 2% T gel applied once daily to the thighs or lower abdominal/pubic area (300 mcg T per day) for 6 months | Drug | Hypoactive Sexual Desire Disorder |
| Estradiol ovulesIntravaginal estradiol ovules taken daily for 2 weeks and afterwards twice a week, for 6 months | Drug | Moderate to severe VVA |
| MoisturizerLocal non-hormonal moisturizers applied regularly every 2-3 days and lubricants as needed | Drug | Mild to moderate VVA |
| Testosterone gel + Estradiol ovulesAlso: EstradiolTransdermal 2% T gel applied once daily to the thighs or lower abdominal/pubic area (300 mcg T per day), plus Intravaginal estradiol ovules taken daily for 2 weeks and afterwards twice a week, for 6 months | Drug | HSDD + VVA |
Primary outcome
Changes of clitoral artery peak systolic velocity (PSV) in women treated with testosterone gel
Time frame: 6 months
parameter evaluated at clitoral color Doppler ultrasound
Changes of clitoral artery pulsatility index (PI) in women treated with testosterone gel
Time frame: 6 months
parameter evaluated at clitoral color Doppler ultrasound
Changes of clitoral artery acceleration (ACC) in women treated with testosterone gel
Time frame: 6 months
parameter evaluated at clitoral color Doppler ultrasound
3 secondary outcomes
Difference in changes of clitoral artery PSV among the 4 intervention groups
Time frame: 6 months
Difference in changes of clitoral artery PI among the 4 intervention groups
Time frame: 6 months
Difference in changes of clitoral artery ACC among the 4 intervention groups
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Background: PubMed 31263248Scavello I, Maseroli E, Di Stasi V, Cipriani S, Verde N, Magini A, Maggi M, Vignozzi L. Nomegestrol acetate/17beta-estradiol does not negatively alter the vascular resistance of clitoral arteries: a prospective, exploratory study. Int J Impot Res. 2020 Mar;32(2):239-247. doi: 10.1038/s41443-019-0162-7. Epub 2019 Jul 1.
- Background: PubMed 29661689Maseroli E, Scavello I, Vignozzi L. Cardiometabolic Risk and Female Sexuality-Part II. Understanding (and Overcoming) Gender Differences: The Key Role of an Adequate Methodological Approach. Sex Med Rev. 2018 Oct;6(4):525-534. doi: 10.1016/j.sxmr.2018.03.004. Epub 2018 Apr 13.
- Background: PubMed 31498871Davis SR, Baber R, Panay N, Bitzer J, Perez SC, Islam RM, Kaunitz AM, Kingsberg SA, Lambrinoudaki I, Liu J, Parish SJ, Pinkerton J, Rymer J, Simon JA, Vignozzi L, Wierman ME. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4660-4666. doi: 10.1210/jc.2019-01603.
- Derived from this study: PubMed 34118018Cipriani S, Maseroli E, Di Stasi V, Scavello I, Todisco T, Rastrelli G, Fambrini M, Sorbi F, Petraglia F, Jannini EA, Maggi M, Vignozzi L. Effects of testosterone treatment on clitoral haemodynamics in women with sexual dysfunction. J Endocrinol Invest. 2021 Dec;44(12):2765-2776. doi: 10.1007/s40618-021-01598-1. Epub 2021 Jun 12.
Related trials for Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Hypoactive Sexual Desire Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoactive Sexual Desire Disorder and Vulvovaginal Disease, run by University of Florence at 1 site in Italy.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 7 Apr 2020. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of clitoral artery peak systolic velocity (PSV) in women treated with testosterone gel (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT04336891, which also lists 4 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 7 Apr 2020.