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Trial record 12 of 51 for:    "Hypogonadism" | "Estrogens"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00962637
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : February 11, 2010
Information provided by:
Repros Therapeutics Inc.

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: AndroGel Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : March 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Androxal™ 12.5 mg
Drug: Androxal
12.5 mg once daily
Other Name: Enclomiphene citrate

Experimental: 2
Androxal™ 25 mg
Drug: Androxal
25 mg once daily
Other Name: Enclomiphene citrate

Active Comparator: 3
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
Drug: Placebo
1 capsule daily

Primary Outcome Measures :
  1. Evaluate the safety of Androxal™ administered in men with secondary hypogonadism [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel® [ Time Frame: Six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00962637

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United States, Alabama
Alabama Clinical Therapeutics, LLC
Birmingham,, Alabama, United States, 35235
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
United States, California
Northern California Research Corp.
Carmichael, California, United States, 95608
Prime-Care Clinical Research
Mission Viejo, California, United States, 92691
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Connecticut
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
Southeastern Research Group, Inc.
Tallahassee, Florida, United States, 32308
United States, Indiana
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States, 46825
United States, Kentucky
Commonwealth Biomedical Research
Madisonville, Kentucky, United States, 42431
United States, Maryland
The Center for Sexual Medicine at Sheppard Pratt
Baltimore, Maryland, United States, 21285
United States, Michigan
Office of Keith Pierce, MD
Livonia, Michigan, United States, 48152
United States, Nevada
Office of Michael Mall, MD
Las Vegas, Nevada, United States, 89109
Office of Stephen Miller, MD
Las Vegas, Nevada, United States, 89144
United States, New Jersey
Advanced Biomedical Research, Inc.
Hackensack, New Jersey, United States, 07601
Office of Gary S. Karlin
Lawrenceville, New Jersey, United States, 08648
United States, Tennessee
Medial Research Associates of Nashville
Nashville, Tennessee, United States, 37203
United States, Texas
Urology San Antonio Research, PA
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Repros Therapeutics Inc.
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Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.

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Responsible Party: Andre van As, MD, PhD, Repros Therapeutics, Inc. Identifier: NCT00962637     History of Changes
Other Study ID Numbers: ZA-003
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: February 11, 2010
Last Verified: February 2010
Keywords provided by Repros Therapeutics Inc.:
Secondary Hypogonadism
Additional relevant MeSH terms:
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Estrogen Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal