Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146146
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2005-09-01
Brief Title:
Testosterone and Its Metabolites in GID
Sponsor:
Unita Complessa di Ostetricia e Ginecologia
Organization:
Unita Complessa di Ostetricia e Ginecologia
Study Overview
Official Title:
Role of Testosterone and Its Metabolites Regarding Different Physiological Functions in Subjects Affected by Gender Identity Disorder FtM Transsexuals
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are
to determine the role of testosterone versus dihydrotestosterone with respect to the following physiological functions bone metabolism body composition insulin resistance and lipid profile
to determine the role of testosterone and dihydrotestosterone versus estradiol with respect to the following physiological functions bone metabolism body composition insulin resistance and lipid profile
to determine the role of testosterone versus dihydrotestosterone with respect to the following physiological functions bone metabolism body composition insulin resistance and lipid profile
to determine the role of testosterone and dihydrotestosterone versus estradiol with respect to the following physiological functions bone metabolism body composition insulin resistance and lipid profile
Detailed Description:
BACKGROUND GID is a psychic disorder in which an otherwise normal person feels like heshe is a member of the opposite sex to which shehe belongs biologically These patients require hormonal treatment to suppress the somatic characteristics of their own sex and to develop the somatic characteristics of the other sex After psychotherapy and a period of hormonal treatment they undergo surgical sex reassignment which in the case of FtM subjects consists of hystero-adnexectomy reductive mastoplasty and possibly penile reconstruction Thereafter and for their entire life they must be treated with testosterone T to maintain androgen-dependent physiological functions
RATIONALE After sex-reassignment surgery FtM subjects must be treated with T for their entire life in order to maintain androgen-estrogen dependent physiological functions
These subjects represent an interesting model for the study of the effects of testosterone and its metabolites on different physiological functions As of now there is no information that the androgen receptors differ in males and females Therefore induction of the androgen effects in the FtM subjects can be considered similar to those in hypogonadal men and FtM subjects can serve as a model of the hypogonadal male
Therefore the aim of this trial is to evaluate the effects of selective steroid replacement on different physiological functions In particular in this study we will evaluate the relative role of testosterone DHT and estradiol on the different physiological functions For these purposes we will administer testosterone undecanoate alone Group A or in combination with letrozole an aromatase inhibitor Group B A third group of FtM subjects will be treated with TU plus dutasteride Group C
In view of the development of selective androgen receptor modulators the understanding of the relative role of each steroid on different physiological functions will provide useful information for future therapeutic indications The information collected in this study will greatly help to optimize the long-term treatment of FtM subjects
In particular in this study we will test the following questions
what is the role of testosterone vs DHT on the physiological functions evaluated in this study ie bone metabolism body composition insulin resistance and lipid profile Group B vs Group C
what is the role of testosterone and DHT vs estradiol on the physiological functions evaluated in this study ie bone metabolism body composition insulin resistance and lipid profile Group C vs Group A
DESIGN
For this purpose in this study we will treat FtM castrated subjects for 54 weeks with
testosterone undecanoate 1000 mg 6-12 weeks injection at week 0 6 18 30 42 and 54n5 Group A
testosterone undecanoate 1000 mg 6-12 weeks injection at week 0 6 18 30 42 and 54 mgday plus letrozole 25 mgday n5 Group B
testosterone undecanoate 1000 mg 6-12 weeks injection at week 0 6 18 30 42 and 54 plus dutasteride 05 mgday n5 Group C
Overall study design and plan-description Prospective phase III randomized study design will be used The study consists of a control phase lasting 3 weeks and a 54-week treatment period
Control phase will last 3 weeks In this period subjects will provide three fasting at least 10 hours blood samples and one urine sample Subjects will undergo 2 visits to ensure fulfillment of inclusion criteria and absence of exclusion criteria to determine state of health and to be informed about the purposes of the study During the two visits they will undergo
blood drawings for measurements of LH FSH estradiol testosterone DHEAS total cholesterol HDL cholesterol triglycerides insulin glucose leptin adiponectin uric acid urea creatinine Na K Ca P Mg Cl total protein bone alkaline phosphate PTH osteocalcin crosslaps 25OH vit D H RANKL osteoprotegerin
anthropometry weight measures
DEXA for bone mass determination and body composition
physical examination
a sexual and behavioral questionnaire
a pain questionnaire
Treatment phase All injections will be administered by the investigator or co-investigators for the entire study Fasting 10 hours blood samples will be taken immediately before giving the injections every time subjects come for injections week 0 6 18 30 and 42 and at the end of the treatment phase On these occasions a physical examination including weight blood pressure and pulse rate checks will be performed Volunteers will be asked to complete a sexual and behavioral questionnaire and a pain questionnaire during these visits
At week 6 18 30 and 42 the following tests will be performed
blood drawings for measurements of LH FSH estradiol testosterone DHT total cholesterol HDL cholesterol triglycerides insulin glucose leptin adiponectin uric acid urea creatinine Na K Ca P Mg Cl total protein
anthropometry weight measures
physical examination
sexual and behavioral questionnaire
pain questionnaire
At week 54 the following tests will be performed
blood drawings for measurements of LH FSH estradiol testosterone DHT DHEAS total cholesterol HDL cholesterol triglycerides insulin glucose leptin adiponectin uric acid urea creatinine Na K Ca P Mg Cl total protein bone alkaline phosphate PTH osteocalcin crosslaps 25OH vit D H RANKL osteoprotegerin
anthropometry weight measures
DEXA for bone mass determination and body composition
physical examination
sexual and behavioral questionnaire
pain questionnaire
Measurements
Blood samples10 hours from last food intake Blood collections will be carried out by venipuncture After resting at room temperature for 30 min the sample will be centrifuged at 3000 rpm for 10 min Serum samples about 10 ml from each blood sample will be stored at -20C for analysis
Physical examinations
They will include inspection of external genitalia clitorides and a visit to detect appearance of acne and gynecomastia
Sexual function and behavior questionnaire
In the sexual and behavior questionnaire the subjects will judge their sexual activity and behavior in the period between visits The subjects have the possibility to making additional comments about important events and disturbances
SELECTION OF STUDY POPULATION
Healthy female FtM subjects who have undergone SR surgery hystero-adnexectomy will be recruited to participate in this study Healthy female subjects between 18 to 45 years of age will be enrolled in the study according to InclusionExclusion Criteria listed below They will be informed about the nature aim and objectives of the study and will be required to give their written consent to participate in the study The presence of the inclusion criteria and the absence of the exclusion criteria will be documented in the Case Report Forms CRF
RATIONALE After sex-reassignment surgery FtM subjects must be treated with T for their entire life in order to maintain androgen-estrogen dependent physiological functions
These subjects represent an interesting model for the study of the effects of testosterone and its metabolites on different physiological functions As of now there is no information that the androgen receptors differ in males and females Therefore induction of the androgen effects in the FtM subjects can be considered similar to those in hypogonadal men and FtM subjects can serve as a model of the hypogonadal male
Therefore the aim of this trial is to evaluate the effects of selective steroid replacement on different physiological functions In particular in this study we will evaluate the relative role of testosterone DHT and estradiol on the different physiological functions For these purposes we will administer testosterone undecanoate alone Group A or in combination with letrozole an aromatase inhibitor Group B A third group of FtM subjects will be treated with TU plus dutasteride Group C
In view of the development of selective androgen receptor modulators the understanding of the relative role of each steroid on different physiological functions will provide useful information for future therapeutic indications The information collected in this study will greatly help to optimize the long-term treatment of FtM subjects
In particular in this study we will test the following questions
what is the role of testosterone vs DHT on the physiological functions evaluated in this study ie bone metabolism body composition insulin resistance and lipid profile Group B vs Group C
what is the role of testosterone and DHT vs estradiol on the physiological functions evaluated in this study ie bone metabolism body composition insulin resistance and lipid profile Group C vs Group A
DESIGN
For this purpose in this study we will treat FtM castrated subjects for 54 weeks with
testosterone undecanoate 1000 mg 6-12 weeks injection at week 0 6 18 30 42 and 54n5 Group A
testosterone undecanoate 1000 mg 6-12 weeks injection at week 0 6 18 30 42 and 54 mgday plus letrozole 25 mgday n5 Group B
testosterone undecanoate 1000 mg 6-12 weeks injection at week 0 6 18 30 42 and 54 plus dutasteride 05 mgday n5 Group C
Overall study design and plan-description Prospective phase III randomized study design will be used The study consists of a control phase lasting 3 weeks and a 54-week treatment period
Control phase will last 3 weeks In this period subjects will provide three fasting at least 10 hours blood samples and one urine sample Subjects will undergo 2 visits to ensure fulfillment of inclusion criteria and absence of exclusion criteria to determine state of health and to be informed about the purposes of the study During the two visits they will undergo
blood drawings for measurements of LH FSH estradiol testosterone DHEAS total cholesterol HDL cholesterol triglycerides insulin glucose leptin adiponectin uric acid urea creatinine Na K Ca P Mg Cl total protein bone alkaline phosphate PTH osteocalcin crosslaps 25OH vit D H RANKL osteoprotegerin
anthropometry weight measures
DEXA for bone mass determination and body composition
physical examination
a sexual and behavioral questionnaire
a pain questionnaire
Treatment phase All injections will be administered by the investigator or co-investigators for the entire study Fasting 10 hours blood samples will be taken immediately before giving the injections every time subjects come for injections week 0 6 18 30 and 42 and at the end of the treatment phase On these occasions a physical examination including weight blood pressure and pulse rate checks will be performed Volunteers will be asked to complete a sexual and behavioral questionnaire and a pain questionnaire during these visits
At week 6 18 30 and 42 the following tests will be performed
blood drawings for measurements of LH FSH estradiol testosterone DHT total cholesterol HDL cholesterol triglycerides insulin glucose leptin adiponectin uric acid urea creatinine Na K Ca P Mg Cl total protein
anthropometry weight measures
physical examination
sexual and behavioral questionnaire
pain questionnaire
At week 54 the following tests will be performed
blood drawings for measurements of LH FSH estradiol testosterone DHT DHEAS total cholesterol HDL cholesterol triglycerides insulin glucose leptin adiponectin uric acid urea creatinine Na K Ca P Mg Cl total protein bone alkaline phosphate PTH osteocalcin crosslaps 25OH vit D H RANKL osteoprotegerin
anthropometry weight measures
DEXA for bone mass determination and body composition
physical examination
sexual and behavioral questionnaire
pain questionnaire
Measurements
Blood samples10 hours from last food intake Blood collections will be carried out by venipuncture After resting at room temperature for 30 min the sample will be centrifuged at 3000 rpm for 10 min Serum samples about 10 ml from each blood sample will be stored at -20C for analysis
Physical examinations
They will include inspection of external genitalia clitorides and a visit to detect appearance of acne and gynecomastia
Sexual function and behavior questionnaire
In the sexual and behavior questionnaire the subjects will judge their sexual activity and behavior in the period between visits The subjects have the possibility to making additional comments about important events and disturbances
SELECTION OF STUDY POPULATION
Healthy female FtM subjects who have undergone SR surgery hystero-adnexectomy will be recruited to participate in this study Healthy female subjects between 18 to 45 years of age will be enrolled in the study according to InclusionExclusion Criteria listed below They will be informed about the nature aim and objectives of the study and will be required to give their written consent to participate in the study The presence of the inclusion criteria and the absence of the exclusion criteria will be documented in the Case Report Forms CRF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None