NCT00706719

Brief Summary

The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 8, 2010

Completed
Last Updated

August 19, 2015

Status Verified

July 1, 2015

Enrollment Period

1.1 years

First QC Date

June 25, 2008

Results QC Date

August 25, 2010

Last Update Submit

July 22, 2015

Conditions

Secondary Hypogonadism

Keywords

Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH)Secondary hypogonadismSemen volumeSperm countSperm motility

Outcome Measures

Primary Outcomes (3)

  • Sperm Concentration

    Total sperm concentration was measured.

    Baseline, Month 3, Month 6, Follow-Up (Month 7)

  • Motile Total Sperm Count

    Motile total sperm count was measured.

    Baseline, Month 3, Month 6, Follow-Up (Month 7)

  • Semen Volume

    Semen volume was measured.

    Baseline, Month 3, Month 6, Follow-Up (Month 7)

Secondary Outcomes (2)

  • Luteinizing Hormone (LH) Levels

    Baseline, Month 3, Month 6, Follow-Up (Month 7)

  • Follicle Stimulating Hormone (FSH) Levels

    Baseline, Month 3, Month 6, Follow-Up (Month 7)

Study Arms (3)

25 mg Androxal no wash out

EXPERIMENTAL

1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period

Drug: 25 mg Androxal

Testim 1% (topical testosterone)

ACTIVE COMPARATOR

Testim 1% Gel applied topically for 6 months

Drug: Testim 1%

25 mg Androxal wash out

EXPERIMENTAL

1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone

Drug: 25 mg Androxal

Interventions

25 mg AndroxalDRUG

25 mg Androxal capsules, 1 capsule daily for 6 months

Also known as: Enclomiphene citrate
25 mg Androxal no wash out25 mg Androxal wash out
Testim 1%DRUG

Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

Also known as: Topical testosterone
Testim 1% (topical testosterone)

Eligibility Criteria

Age21 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.
  • Subjects must have been treated with a topical testosterone replacement therapy (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more than 2 years.

You may not qualify if:

  • A history of idiopathic infertility due to primary hypogonadism, testicular failure, Kallmann's syndrome or any other infertility condition.
  • Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile other than AIHH.
  • Men with a history of, known, or suspected prostate disease not ruled out by a prostate biopsy, or a prostate specific antigen (PSA)\>3.6 or clinical suspicion of current prostate disease.
  • Men with a hematocrit in excess of 50 % or hemoglobin \>17 g/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Urology Associates

New York, New York, 10016, United States

Location

MAZE Labs

Purchase, New York, 10577, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

EnclomipheneTestosterone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ClomipheneStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Ronald Wiehle, PhD
Organization
Repros Therapeutics, Inc
rwiehle@reprosrx.com
281.719.3406

Study Officials

  • Ronald Wiehle, PhD

    Repros Therapeutics Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2008

First Posted

June 27, 2008

Study Start

June 1, 2008

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

August 19, 2015

Results First Posted

October 8, 2010

Record last verified: 2015-07

Locations

US(2)