Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
1 other identifier
interventional
83
1 country
18
Brief Summary
The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2011
Shorter than P25 for phase_2
18 active sites
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
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 4, 2011
CompletedFirst Posted
Study publicly available on registry
January 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
July 28, 2014
CompletedJuly 28, 2014
June 1, 2014
11 months
January 4, 2011
June 18, 2014
June 27, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Total Morning Testosterone
Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim
3 months
Secondary Outcomes (3)
Change in Luteinizing Hormone Levels
3 months
Change in FSH After 3 Months of Treatment
3 months
Reproductive Safety
3 months
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo
Testim (topical testosterone)
ACTIVE COMPARATORTestim (topical testosterone)
Androxal 12.5 mg
EXPERIMENTALAndroxal 12.5 mg/day
Androxal 25 mg
EXPERIMENTALAndroxal 25 mg/day
Interventions
testosterone gel applied 1x daily for 3 months
Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
Eligibility Criteria
You may qualify if:
- Healthy males between the ages of 21 and 65 years of age
- All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
- Previously or concurrently diagnosed as having secondary hypogonadism and confirmed morning testosterone \<250ng/dL (two assessments at least 10 days apart)
- Ability to complete the study in compliance with the protocol
- Ability to understand and provide written informed consent
- Agreement to use double barrier contraception if with a fertile female partner
- Agreement to provide a semen sample in the clinic
You may not qualify if:
- Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 6 months prior to study
- Use of spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
- Use of Clomid in the past year
- Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study
- A hematocrit \>50% or a hemoglobin \>17 g/dL
- Clinically significant abnormal findings on screening examination
- Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication
- Known hypersensitivity to Clomid
- Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade \> 2 based on 0-4 scale or any trace of posterior subcapsular cataract)
- Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
- Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)
- Current or history of breast cancer
- Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA\>3.6
- Presence or history of hyperprolactinemia with or without a tumor
- Chronic use of medications use such as glucocorticoids
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Paradigm Clinical Inc.
Garden Grove, California, 92844, United States
Northern California Research Corp
Sacramento, California, 95831, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Los Angeles Biomedical Research Institute
Torrance, California, 90502, United States
Affiliated Clinical Research
Las Vegas, Nevada, 89109, United States
Affiliated Clinical Research Inc.
Las Vegas, Nevada, 89144, United States
Weill Cornell Medical College and Smith Institute
Great Neck, New York, 11021, United States
Jed Kaminetsky
New York, New York, 10016, United States
Natan Bar-Chama
New York, New York, 10022, United States
Michael A Werner
Purchase, New York, 10577, United States
Discovery Clinical Trials
Austin, Texas, 78758, United States
Research Across America
Carrollton, Texas, 75010, United States
Texas Urology Specialist
Houston, Texas, 77024, United States
Centex Research
Houston, Texas, 77062, United States
Endocrine and Psychiatry Center
Houston, Texas, 77095, United States
Protenium Clinical Research
Hurst, Texas, 76054, United States
R/D Clinical Research
Lake Jackson, Texas, 77566, United States
Cetero Research
San Antonio, Texas, 78229, United States
Related Publications (1)
Wiehle RD, Fontenot GK, Wike J, Hsu K, Nydell J, Lipshultz L; ZA-203 Clinical Study Group. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone. Fertil Steril. 2014 Sep;102(3):720-7. doi: 10.1016/j.fertnstert.2014.06.004. Epub 2014 Jul 17.
PMID: 25044085DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer L. Wike
- Organization
- Repros Therapeutics Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Larry Lipshultz, MD
Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2011
First Posted
January 5, 2011
Study Start
January 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 28, 2014
Results First Posted
July 28, 2014
Record last verified: 2014-06