Clomiphene in Males With Prolactinomas and Persistent Hyp... | NCT00697814

Studies
Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

NCT00697814

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Jun 16, 2008Estimated

Enrollment

15Actual

Phase

Phase 2

Conditions

Hypogonadotropic Hypogonadism
Prolactinoma

Interventions

Clomiphene citrate

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Jun 12, 2008

First Submission Date that Met QC Criteria

Jun 13, 2008

First Posted Date

Jun 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2008

Last Update Posted Date

Jun 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clomiphene	Experimental	Clomiphene 50 mg/day for 12 weeks	Drug: Clomiphene citrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clomiphene citrate	Drug	Clomiphene 50 mg/day for 12 weeks	Clomiphene

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
Assess the effects of CC on sexual function, fertility, body composition, lipid and glucose metabolism, and quality of life were also evaluated.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julio Abucham, MD, PhD	Neuroendocrine Unit	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)		São Paulo	São Paulo	09541-330	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D007006	Hypogonadism
D015175	Prolactinoma

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases
D000236	Adenoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002996	Clomiphene

Ancestor Terms

ID	Term
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided