A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Repros Therapeutics Inc.

ClinicalTrials.gov Identifier:

NCT01386567

First received: June 29, 2011

Last updated: May 16, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 29, 2011
Last Updated Date	May 16, 2013
Start Date ^ICMJE	July 2011
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 30, 2011)	Change in testosterone comparing Androxal to Testim [ Time Frame: 1 year ] [ Designated as safety issue: No ] Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01386567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 30, 2011)	Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) [ Time Frame: 1 year ] [ Designated as safety issue: No ] Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] Reproductive safety will be assessed by changes in values from baseline of semen volume, and sperm concentration, total count, morphology and motility at baseline (Visit 1), month 4, 6 and 12 comparing Androxal 12.5 and 25 mg to Testim
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
Official Title ^ICMJE	A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203
Brief Summary	The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hypogonadism Low Testosterone
Intervention ^ICMJE	Drug: Androxal (enclomiphene citrate) capsules oral 1x a day 1 year Other Name: enclomiphene citrate Drug: Testim (topical testosterone) topical 1 tube 1x a day 1 year Other Names: topical testosterone exogenous testosterone testosterone gel
Study Arm (s)	Experimental: Androxal Androxal (enclomiphene citrate)12.5 mg or 25 mg Intervention: Drug: Androxal (enclomiphene citrate) Active Comparator: Testim (topical testosterone) Intervention: Drug: Testim (topical testosterone)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	48
Completion Date	January 2013
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Successful completion of ZA-203 Ability to understand and provide written informed consent Agreement to use a condom, and with a fertile female partner, another form of contraception Agreement to provide semen samples in the clinic Exclusion Criteria: Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
Gender	Male
Ages	21 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01386567
Other Study ID Numbers ^ICMJE	ZA-203 Extension
Has Data Monitoring Committee	No
Responsible Party	Repros Therapeutics Inc.
Study Sponsor ^ICMJE	Repros Therapeutics Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Repros Therapeutics Inc.
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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