Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
This study has been completed.
Sponsor:
Federal University of São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00697814
First received: June 12, 2008
Last updated: June 13, 2008
Last verified: June 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypogonadotropic Hypogonadism Prolactinoma |
Drug: Clomiphene citrate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Primary Purpose: Treatment |
| Official Title: | Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism |
Resource links provided by NLM:
Further study details as provided by Federal University of São Paulo:
Primary Outcome Measures:
- assess the effects of CC treatment on testosterone levels in male patients with prolactinomas and persistent HH on dopaminergic agonist therapy [ Time Frame: 10 days, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess the effects of CC on sexual function, fertility, body composition, lipid and glucose metabolism, and quality of life were also evaluated.
| Enrollment: | 15 |
| Study Start Date: | June 2004 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Clomiphene
Clomiphene 50 mg/day for 12 weeks
|
Drug: Clomiphene citrate
Clomiphene 50 mg/day for 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697814
Locations
| Brazil | |
| Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP) | |
| Sao Paulo, SP, Brazil, 09541-330 | |
Sponsors and Collaborators
Federal University of São Paulo
Investigators
| Study Chair: | Julio Abucham, MD, PhD | Neuroendocrine Unit |
More Information
No publications provided
| Responsible Party: | Julio Abucham, Neuroendocrine Unit |
| ClinicalTrials.gov Identifier: | NCT00697814 History of Changes |
| Other Study ID Numbers: | 1374/04 |
| Study First Received: | June 12, 2008 |
| Last Updated: | June 13, 2008 |
| Health Authority: | Brazil: National Committee of Ethics in Research Brazil: Ministry of Health |
Keywords provided by Federal University of São Paulo:
|
Hypogonadotropic hypogonadism Prolactinoma |
Additional relevant MeSH terms:
|
Hypogonadism Prolactinoma Gonadal Disorders Endocrine System Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pituitary Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Pituitary Diseases Hypothalamic Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Clomiphene Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Fertility Agents, Female Fertility Agents Reproductive Control Agents Therapeutic Uses Selective Estrogen Receptor Modulators |
ClinicalTrials.gov processed this record on May 16, 2013