NCT00697814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2008

Completed
Last Updated

June 16, 2008

Status Verified

June 1, 2008

Enrollment Period

1 year

First QC Date

June 12, 2008

Last Update Submit

June 13, 2008

Conditions

Hypogonadotropic HypogonadismProlactinoma

Keywords

Hypogonadotropic hypogonadismProlactinoma

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

Study Arms (1)

Clomiphene

EXPERIMENTAL

Clomiphene 50 mg/day for 12 weeks

Drug: Clomiphene citrate

Interventions

Clomiphene citrateDRUG

Clomiphene 50 mg/day for 12 weeks

Clomiphene

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • impossibility to attend scheduled visits and irregular compliance to DA treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)

São Paulo, São Paulo, 09541-330, Brazil

Location

MeSH Terms

Conditions

HypogonadismProlactinoma

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPituitary NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SitePituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Julio Abucham, MD, PhD

    Neuroendocrine Unit

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 16, 2008

Study Start

June 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

June 16, 2008

Record last verified: 2008-06

Locations

BR(1)