NCT01904734

Brief Summary

This study aims to explore whether men with low testosterone levels, due to altered brain regulation of male hormone function, who have been previously treated with testosterone, respond as well as men who have not been so treated to clomiphene citrate, an agent commonly used for female infertility that has been shown to improve male hormone secretion in some cases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2012

Longer than P75 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

October 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

6.1 years

First QC Date

July 15, 2013

Last Update Submit

March 8, 2021

Conditions

Hypogonadism, Male

Keywords

testosteronehypogonadismpituitary

Outcome Measures

Primary Outcomes (1)

  • Total serum testosterone

    laboratory measurement by standard immunometric method

    at the end of 8 weeks of treatment

Secondary Outcomes (2)

  • Bioavailable testosterone

    at the end of 8 weeks of treatment

  • Serum sex hormone binding globulin (SHBG)level

    at the end of 8 weeks of treatment

Study Arms (2)

No previous male hormone treatment

ACTIVE COMPARATOR

Clomiphene

Drug: Clomiphene

Previously treated with testosterone

ACTIVE COMPARATOR

Clomiphene

Drug: Clomiphene

Interventions

ClomipheneDRUG

Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks

Also known as: Clomid, Clomiphene citrate
No previous male hormone treatmentPreviously treated with testosterone

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient or eligible for care at Phoenix VA Health Care System
  • Male ages 30-70 years
  • testosterone level below 250 ng/dl before treatment
  • able to provide informed written consent

You may not qualify if:

  • evidence of pituitary tumor \>1mm by MRI or CAT scan
  • chronic illness (renal, cardiac, liver failure)
  • Prostate specific antigen (PSA) \>4.0 ng/ml
  • history of prostate, breast, or testicular cancer
  • eye disease compromising vision (e.g. cataracts)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix VA Health Care System

Phoenix, Arizona, 85012, United States

Location

Related Publications (3)

  • Moskovic DJ, Katz DJ, Akhavan A, Park K, Mulhall JP. Clomiphene citrate is safe and effective for long-term management of hypogonadism. BJU Int. 2012 Nov;110(10):1524-8. doi: 10.1111/j.1464-410X.2012.10968.x. Epub 2012 Mar 28.

    PMID: 22458540BACKGROUND

  • Katz DJ, Nabulsi O, Tal R, Mulhall JP. Outcomes of clomiphene citrate treatment in young hypogonadal men. BJU Int. 2012 Aug;110(4):573-8. doi: 10.1111/j.1464-410X.2011.10702.x. Epub 2011 Nov 1.

    PMID: 22044663BACKGROUND

  • Taylor F, Levine L. Clomiphene citrate and testosterone gel replacement therapy for male hypogonadism: efficacy and treatment cost. J Sex Med. 2010 Jan;7(1 Pt 1):269-76. doi: 10.1111/j.1743-6109.2009.01454.x. Epub 2009 Aug 17.

    PMID: 19694928BACKGROUND

MeSH Terms

Conditions

EunuchismHypogonadismPituitary Diseases

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sherman M Harman, MD, PhD

    Phoenix VA Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Endocrine Division, Dept. of Internal Medicine

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 22, 2013

Study Start

October 1, 2012

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

US(1)