Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
Phase 2
Completed
- Conditions
- Hypogonadotropic HypogonadismProlactinoma
- Interventions
- Registration Number
- NCT00697814
- Lead Sponsor
- Federal University of São Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Clomiphene Clomiphene citrate Clomiphene 50 mg/day for 12 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Assess the effects of CC on sexual function, fertility, body composition, lipid and glucose metabolism, and quality of life were also evaluated.
Trial Locations
- Locations (1)
Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)
🇧🇷Sao Paulo, SP, Brazil