Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters. (TESTOFSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336891
Recruitment Status : Completed
First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Linda Vignozzi, MD, University of Florence

Brief 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). 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).


Condition or disease Intervention/treatment
Hypoactive Sexual Desire Disorder Vulvovaginal Disease Menopause Related Conditions Dyspareunia (Female Excluding Psychogenic) Hypoestrogenism Arousal Disorders, Sexual Drug: Testosterone gel Drug: Estradiol ovules Drug: Moisturizer Drug: Testosterone gel + Estradiol ovules

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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pilot Retrospective Study on the Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
Actual Study Start Date : March 20, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : March 31, 2020


Group/Cohort Intervention/treatment
Hypoactive Sexual Desire Disorder
Women with Hypoactive Sexual Desire Disorder (HSDD, n=23)
Drug: Testosterone gel
Transdermal 2% T gel applied once daily to the thighs or lower abdominal/pubic area (300 mcg T per day) for 6 months

Moderate to severe VVA
Women with dyspareunia due to moderate to severe vulvovaginal atrophy (VVA) (n=12)
Drug: Estradiol ovules
Intravaginal estradiol ovules taken daily for 2 weeks and afterwards twice a week, for 6 months

Mild to moderate VVA
Women with dyspareunia due to mild to moderate VVA (n=37)
Drug: Moisturizer
Local non-hormonal moisturizers applied regularly every 2-3 days and lubricants as needed

HSDD + VVA
Women with HSDD reporting also significant dyspareunia due to moderate to severe VVA (n=9).
Drug: Testosterone gel + Estradiol ovules
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
Other Name: Estradiol




Primary Outcome Measures :
  1. 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

  2. Changes of clitoral artery pulsatility index (PI) in women treated with testosterone gel [ Time Frame: 6 months ]
    parameter evaluated at clitoral color Doppler ultrasound

  3. Changes of clitoral artery acceleration (ACC) in women treated with testosterone gel [ Time Frame: 6 months ]
    parameter evaluated at clitoral color Doppler ultrasound


Secondary Outcome Measures :
  1. Difference in changes of clitoral artery PSV among the 4 intervention groups [ Time Frame: 6 months ]
  2. Difference in changes of clitoral artery PI among the 4 intervention groups [ Time Frame: 6 months ]
  3. Difference in changes of clitoral artery ACC among the 4 intervention groups [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Changes in Female Sexual Function Index (FSFI) Total, desire, arousal, lubrication, orgasm, satisfaction and pain scores, in women treated with transdermal Testosterone [ Time Frame: 6 months ]
  2. Changes in serum total Testosterone levels in women treated with transdermal Testosterone [ Time Frame: 6 months ]
    Women were asked to have blood samples drawn in the morning, after an overnight fast, during the early follicular phase (if premenopausal)

  3. Changes in serum total Sex Hormone Binding Globulin (SHBG) levels in women treated with transdermal Testosterone [ Time Frame: 6 months ]
    Women were asked to have blood samples drawn in the morning, after an overnight fast, during the early follicular phase (if premenopausal)

  4. Difference in changes of - Total cholesterol, high-density lipoprotein cholesterol, triglycerides, glycated hemoglobin, fasting glucose and insulin levels among the 4 intervention groups [ Time Frame: 6 months ]
    Women were asked to have blood samples drawn in the morning, after an overnight fast



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • being heterosexual.

Exclusion Criteria:

  • history of drug or alcohol abuse
  • a diagnosis of uncontrolled or unstable mental or organic disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336891


Locations
Layout table for location information
Italy
Andrology, Women's Endocrinology and Gender Incongruence Unit, University of Florence, Azienda Ospedaliero-Universitaria Careggi
Florence, Italy, 50136
Sponsors and Collaborators
University of Florence
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Linda Vignozzi, MD, Associate Professor of Endocrinology; Chief of Andrology, Women's Endocrinology and Gender Incongruence, Careggi Hospital, University of Florence
ClinicalTrials.gov Identifier: NCT04336891    
Other Study ID Numbers: FEMENDO1
14457_oss ( Other Identifier: AOU Careggi Ethics Committee )
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linda Vignozzi, MD, University of Florence:
testosterone
female sexual dysfunction
genital vascularization
clitoris
dyspareunia
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyspareunia
Disease
Sexual Dysfunctions, Psychological
Pathologic Processes
Sexual Dysfunction, Physiological
Mental Disorders
Methyltestosterone
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol
Polyestradiol phosphate
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Androgens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents