NCT01739582

Brief Summary

To determine the safety profile of Androxal in men with secondary hypogonadism.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2012

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2014

Enrollment Period

1.4 years

First QC Date

November 29, 2012

Last Update Submit

April 15, 2014

Conditions

Secondary Hypogonadism

Outcome Measures

Primary Outcomes (1)

  • Testosterone levels

    Values of total morning testosterone levels at each visit

    26 weeks

Secondary Outcomes (3)

  • Follicle Stimulating Hormone and Leutinizing Hormone

    26 weeks

  • Diabetic Parameters

    26 weeks

  • Change in weight and body mass index (BMI)

    26 weeks

Study Arms (1)

Androxal

EXPERIMENTAL

Androxal (enclomiphene citrate) 12.5 mg, once daily, oral capsule. Subjects will be up-titrated to 25 mg if testosterone levels remain below 450 ng/dL at visit 2.

Drug: Androxal

Interventions

AndroxalDRUG
Also known as: enclomiphene citrate
Androxal

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Successful completion of either ZA-301 or ZA-302

You may not qualify if:

  • Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hypogonadism

Interventions

Enclomiphene

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ClomipheneStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 3, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 16, 2014

Record last verified: 2014-04