Hypogonadotropic Hypogonadism, Prolactinoma
Conditions
Keywords
Hypogonadotropic hypogonadism, Prolactinoma
Brief summary
Prolactinomas are usually associated with hypogonadotropic hypogonadism in both sexes. Clomiphene citrate is a well known selective estrogen receptor modulator that increases gonadotropin secretion via hypothalamic-pituitary action. We conducted a prospective, open label clinical trial of CC to evaluate its effects in reverting persistent HH in male patients with prolactinomas under dopaminergic agonist treatment.
Interventions
DRUGClomiphene citrate
Clomiphene 50 mg/day for 12 weeks
Sponsors
Federal University of São Paulo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* a minimum follow-up of 6 months under DA therapy with normal serum prolactin or with maximum DA dose (3.5 mg/week of cabergoline or 10 mg/day of bromocriptine for at least 2 months) * serum total testosterone less than 300ng/dl with normal or low LH and FSH levels after discontinuing testosterone replacement for at least 2 months.
Exclusion criteria
* impossibility to attend scheduled visits and irregular compliance to DA treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| assess the effects of CC treatment on testosterone levels in male patients with prolactinomas and persistent HH on dopaminergic agonist therapy | 10 days, 4, 8 and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assess the effects of CC on sexual function, fertility, body composition, lipid and glucose metabolism, and quality of life were also evaluated. | — |
Countries
Brazil
Outcome results
None listed