To study whether higher estradiol levels in obese men are responisble for the lower testosterone levels also found in these men
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
before every change of estradiol dose and at the end of the study blood is
drawn for determination of estradiol, testosterone, sex hormone binding
globulin and LH
Secondary outcome
non applicable
Background summary
from our previously conducted studies it appeared that circulating estradiol
has a strong and inhibitive effect on gonadotropin release by the male
pituitary. Obese men have higher mean plasma estradiollevels and lower mean
plasma testosterone levels compared to non-obese men.
Study objective
To study whether higher estradiol levels in obese men are responisble for the
lower testosterone levels also found in these men
Study design
open lable intervention study
Intervention
the endogenoud estradiolsynthesis is inhibited by letrozole tablest 2,5 mg
daily. Estradiol levels are varied by application of estradiol patches in
different doses. The effect of varying estradiol levels on the levels of LH and
testosterone are observed and compared with results from a similar study in
non-obese men.
Study burden and risks
duration of the study is 28 days comprising 5 visits (75 minutes in total), 5
venepunctures (35 ml in total). Intake of letrozole 2,5 mg tablets once daily
for 28 days. Application of estradiol patches 2 times per week for a total of 3
weeks.
postbus 7057
1007 mb
Nederland
postbus 7057
1007 mb
Nederland
Listed location countries
Age
Inclusion criteria
male, BMI > 35 kg/m2, age < 40 years
Exclusion criteria
history of hypogonadism, pituitary disease, venous thrombosis. Use of testosterone, aldactone, finasteride, glucocorticoids. LH > 8 IU/L
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19638.029.07 |