Transsexualism Clinical Trial
Official title:
Role of Testosterone and Its Metabolites Regarding Different Physiological Functions in Subjects Affected by Gender Identity Disorder (FtM Transsexuals)
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
BACKGROUND GID is a psychic disorder in which an otherwise normal person feels like he/she is
a member of the opposite sex to which she/he 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 i.e. 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 i.e. 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
54)(n=5) (Group A)
- testosterone undecanoate 1000 mg 6-12 weeks (injection at week 0, 6, 18, 30, 42 and 54)
mg/day plus letrozole 2.5 mg/day (n=5) (Group B)
- testosterone undecanoate 1000 mg 6-12 weeks (injection at week 0, 6, 18, 30, 42 and 54)
plus dutasteride 0.5 mg/day (n=5) (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, 25(OH) 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, 25(OH) 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 samples(10 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
-20°C 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 Inclusion/Exclusion 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).
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