To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

This study has been completed.

Study NCT00706719 Information provided by Repros Therapeutics Inc.

First Received on June 25, 2008. Last Updated on June 29, 2011 History of Changes

Results First Received: August 25, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Infertility in Men Secondary Hypogonadism
Interventions:	Drug: Androxal (enclomiphene citrate) Drug: topical testosterone gel

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Testim (Topical Testosterone)	1% Testim gel applied once daily
Androxal no Washout	25 mg Androxal capsules once daily in men who have not previously washed out topical testosterone
Androxal With Wash Out	25 mg capules once daily in men who have previously had a 3 month wash out of topical testosterone

Participant Flow: Overall Study

	Testim (Topical Testosterone)	Androxal no Washout	Androxal With Wash Out
STARTED	5	7	5
COMPLETED	5	6	1
NOT COMPLETED	0	1	4

Baseline Characteristics

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Reporting Groups

	Description
Group A Testim	1% Testim gel
Group B Androxal no Wash Out	25 mg Androxal 1 capusule per day in men who have not previously washed out topical testosterone for 3 months
Androxal Wash Out	25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone

Baseline Measures

	Group A Testim	Group B Androxal no Wash Out	Androxal Wash Out	Total
Number of Participants [units: participants]	5	7	5	17
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	5	7	5	17
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	54.4 ± 4.88	48.9 ± 8.99	56.4 ± 23.8	52.7 ± 7.72
Gender [units: participants]
Female	0	0	0	0
Male	5	7	5	17
Region of Enrollment [units: participants]
United States	5	7	5	17

Outcome Measures

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1. Primary:

Mean Sperm Concentration Baseline [ Time Frame: baseline ]

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2. Primary:

Mean Sperm Concentration 3 Months [ Time Frame: 3 months ]

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3. Primary:

Mean Sperm Concentraion 6 Months [ Time Frame: 6 months ]

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4. Primary:

Mean Total Sperm Count Basline [ Time Frame: baseline ]

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5. Primary:

Mean Total Sperm Count 3 Months [ Time Frame: 3 months ]

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6. Primary:

Mean Total Sperm Count 6 Months [ Time Frame: 6 months ]

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7. Primary:

Mean Semen Volume Baseline [ Time Frame: baseline ]

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8. Primary:

Mean Semen Volume 3 Months [ Time Frame: 3 months ]

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9. Primary:

Mean Semen Volume 6 Months [ Time Frame: 6 months ]

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10. Secondary:

Mean Follicle Stimulating Hormone(FSH) and Leutinizing Hormone(LH) Levels From Baseline to 3-months in Men Treated With Androxal® Versus Testim [ Time Frame: baseline, 3 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Ronald Wiehle, PhD
Organization: Repros Therapeutics, Inc
phone: 281.719.3406
e-mail: rwiehle@reprosrx.com

No publications provided

Responsible Party:	Ronald Wiehle, PhD, Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT00706719 History of Changes
Other Study ID Numbers:	ZA-201
Study First Received:	June 25, 2008
Results First Received:	August 25, 2010
Last Updated:	June 29, 2011
Health Authority:	United States: Food and Drug Administration