Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

Sponsor

Repros Therapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00962637

Collaborator

(none)

194

Enrollment

Locations

Arms

Duration (Months)

10.8

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.

Condition or Disease	Intervention/Treatment	Phase
Secondary Hypogonadism	Drug: Androxal Drug: Androxal Drug: AndroGel Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Androxal™ 12.5 mg	Drug: Androxal 12.5 mg once daily Other Names: Enclomiphene citrate
Experimental: 2 Androxal™ 25 mg	Drug: Androxal 25 mg once daily Other Names: Enclomiphene citrate
Active Comparator: 3 AndroGel®	Drug: AndroGel 5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert.
Placebo Comparator: 4 Placebo	Drug: Placebo 1 capsule daily

Outcome Measures

Primary Outcome Measures

Evaluate the safety of Androxal™ administered in men with secondary hypogonadism [Six months]

Secondary Outcome Measures

Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel® [Six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 68 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Total serum testosterone concentrations < 300 ng/dL at baseline

Exclusion Criteria:

Presence or history of prostate cancer
Elevated PSA > 3.5 ng/mL

Additional inclusion and exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Clinical Therapeutics, LLC	Birmingham,	Alabama	United States	35235
2	Medical Affiliated Research Center, Inc.	Huntsville	Alabama	United States	35801
3	Northern California Research Corp.	Carmichael	California	United States	95608
4	Prime-Care Clinical Research	Mission Viejo	California	United States	92691
5	Harbor-UCLA Medical Center	Torrance	California	United States	90502
6	Chase Medical Research, LLC	Waterbury	Connecticut	United States	06708
7	Southeastern Research Group, Inc.	Tallahassee	Florida	United States	32308
8	Northeast Indiana Research, LLC	Fort Wayne	Indiana	United States	46825
9	Commonwealth Biomedical Research	Madisonville	Kentucky	United States	42431
10	The Center for Sexual Medicine at Sheppard Pratt	Baltimore	Maryland	United States	21285
11	Office of Keith Pierce, MD	Livonia	Michigan	United States	48152
12	Office of Michael Mall, MD	Las Vegas	Nevada	United States	89109
13	Office of Stephen Miller, MD	Las Vegas	Nevada	United States	89144
14	Advanced Biomedical Research, Inc.	Hackensack	New Jersey	United States	07601
15	Office of Gary S. Karlin	Lawrenceville	New Jersey	United States	08648
16	Medial Research Associates of Nashville	Nashville	Tennessee	United States	37203
17	Urology San Antonio Research, PA	San Antonio	Texas	United States	78229
18	Salt Lake Research	Salt Lake City	Utah	United States	84107