The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men
1 other identifier
interventional
60
1 country
2
Brief Summary
The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.
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 Jun 2011
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 29, 2011
CompletedFirst Posted
Study publicly available on registry
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
September 23, 2015
CompletedSeptember 23, 2015
August 1, 2015
4 months
June 29, 2011
June 13, 2014
August 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
24 Hour Average and Maximum Testosterone Concentration
The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.
Baseline and Week 6
Secondary Outcomes (2)
Change in Leuteinizing Hormone (LH)
Baseline, Week 2, Week 4, Week 6
Change in Follicle Stimulating Hormone (FSH)
Baseline, Week 2, Week 4, Week 6
Other Outcomes (3)
Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.
Week 6
Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.
Week 6
Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.
Week 6
Study Arms (4)
Androxal 6.25 mg
EXPERIMENTALAndroxal 6.25 mg/day
Androxal 12.5 mg
EXPERIMENTALAndroxal 12.5 mg/day
Androxal 25 mg
EXPERIMENTALAndroxal 25 mg/day
AndroGel
ACTIVE COMPARATORAndroGel 5G topical testosterone
Interventions
capsule oral 1X a day 6 weeks
topical gel 1X a day 6 weeks
Eligibility Criteria
You may qualify if:
- Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.
- All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
- Ability to complete the study in compliance with the protocol
- 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 a semen sample in the clinic
You may not qualify if:
- Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study
- Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
- Use of Clomid in the past year or during the study
- 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. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
- A hematocrit ≥51 % 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
- 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)
- History of breast cancer
- History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA \>3.6
- History of known hyperprolactinemia with or without a tumor
- Chronic use of medications use such as glucocorticoids
- Chronic use of narcotics
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centex Research
Houston, Texas, 77062, United States
Cetero Research
San Antonio, Texas, 78229, United States
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
Jolene Berg, MD
Cetero Research, San Antonio
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2011
First Posted
July 1, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
September 23, 2015
Results First Posted
September 23, 2015
Record last verified: 2015-08