Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247267
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-04-26
Brief Title:
The Effect of Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population
Sponsor:
Walter Reed National Military Medical Center
Organization:
Walter Reed National Military Medical Center
Study Overview
Official Title:
The Effect on Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population on Bone Density Fractures MemoryCognitive Function and Qualities of Life
Status:
RECRUITING
Status Verified Date:
2024-01
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:
It has been known that both estrogen and testosterone are the major sex steroids regulating bone metabolism and other physiological changes in both male and female respectively In postmenopausal women osteoporosis is a major concern secondary to the lack of estrogen These patients also experience a number of physiological changes that affect their life permanently to include hot flashes irritability difficulty concentrating depression and mental confusion In hypogonadal men testosterone deficiency could lead to higher prevalence of depression osteoporosis fracture and frailty Given the new military policy starting to support treatment for gender identity dysphoria military personnel the number of transgender patients in our Endocrinology clinic has been slowly increasing over the past several months These patients will require either testosterone replacement therapy or estrogen therapy to achieve their desired sexual characteristics However as mentioned above the lack of estrogen or testosterone in female and male respectively could cause several issue in their body composition cognitive function and quality of life We designed this prospective case-control study to include patients with hypogonadism and the transgendered populations to learn about the long-term effects of these hormonal replacement therapies on bone density fractures memorycognitive function and quality of life This is a repetitive measures study taken at baseline 6-months and 12-months for three groups consisting of at least 75 subjects The study will involve 3 arms ie Group 1 primarysecondary untreated hypogonadism Group 2 male-to female MTF and Group 3 female-to-male FTM participants that are planning to start hormone replacement therapy as per standard clinical guidelines
Detailed Description:
The Endocrine Society defines male hypogonadism as a clinical syndrome that results from failure of the testis to produce physiological levels of testosterone androgen deficiency and the normal number of spermatozoa caused by disruption of one or more levels of the hypothalamic-pituitary-gonadal HPG axis It is characterized by low serum testosterone high LHhigh FSH concentrations primary hypogonadism or low testosteronelow LHlow FSH secondary hypogonadism The main constellation of signs and symptoms may include erectile dysfunction decreased libido and volume of ejaculation decreased lean body mass with increased body fat loss of body and facial hair weakness fatigue anemia and decreased bone density There is only little data from large cross-sectional studies that address the impact of hypogonadism on morbidity However some small studies have concluded that testosterone deficiency could lead to a higher prevalence of depression osteoporosis fracture and frailty Hypogonadism defined as serum total testosterone level 300 ngdl has been shown to be related to decreased bone mineral density BMD Further review of the literature found various epidemiological studies in men that showed the associations between testosterone and estradiol levels and BMD They found that estrogen has a major role in regulating bone resorption but both estrogen and testosterone play a role in maintaining bone formation A recent published trial in 2017 also showed that testosterone replacement therapy in older men was associated with significant greater improvements in stair-climbing power muscle mass and power Similar studies found that deficiency of testosterone would lead to decrease in lean mass muscle size and strength Given that these two sex steroid hormones testosterone and estrogen play an important role in men and women respectively we also study their long-term effects in the transgender population once they were started on the opposite gender hormone and lack of their own endogenous production
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None