Secondary HypogonadismPhase 2NCT01270841
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
A Phase 2 study testing topical testosterone and Androxal in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 18 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 years, men only
- Conditions the study is for
- Secondary Hypogonadism
- What is being tested?
- topical testosterone and Androxal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 18 sitesUnited States
- Study dates
- Jan 2011to Dec 2011
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Subjects with cystic fibrosis (mutation of the CFTR gene)
- Subjects unable to provide a semen sample in the clinic
- Subject has a BMI >36 kg/m2
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Discovery Clinical Trials
Austin, Texas, 78758
Research Across America
Carrollton, Texas, 75010
Paradigm Clinical Inc.
Garden Grove, California, 92844
Weill Cornell Medical College and Smith Institute
Great Neck, New York, 11021
Texas Urology Specialist
Houston, Texas, 77024
Centex Research
Houston, Texas, 77062
Endocrine and Psychiatry Center
Houston, Texas, 77095
Protenium Clinical Research
Hurst, Texas, 76054
R/D Clinical Research
Lake Jackson, Texas, 77566
Affiliated Clinical Research
Las Vegas, Nevada, 89109
Affiliated Clinical Research Inc.
Las Vegas, Nevada, 89144
Jed Kaminetsky
New York, New York, 10016
Natan Bar-Chama
New York, New York, 10022
Michael A Werner
Purchase, New York, 10577
Northern California Research Corp
Sacramento, California, 95831
Cetero Research
San Antonio, Texas, 78229
Medical Center for Clinical Research
San Diego, California, 92108
Los Angeles Biomedical Research Institute
Torrance, California, 90502
About this study
Official title: 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
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.
Read the detailed description
This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.
- Conditions
- Secondary Hypogonadism
- Being tested
- Placebo, topical testosterone, Androxal
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo capsule 1x daily for 3 months
topical testosteroneDrug
Also called Testim, AndroGel
testosterone gel applied 1x daily for 3 months
AndroxalDrug
Also called Enclomiphene citrate
Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Testim (topical testosterone) | Active comparator | Testim (topical testosterone) Receives: Drug: topical testosterone |
| Androxal 12.5 mg | Experimental | Androxal 12.5 mg/day Receives: Drug: Androxal |
| Androxal 25 mg | Experimental | Androxal 25 mg/day Receives: Drug: Androxal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (3)
Change in Luteinizing Hormone Levels
Changes in values from baseline in LH at month 3
Measured: 3 months
Change in FSH After 3 Months of Treatment
Measured: 3 months
Reproductive Safety
Change from baseline in sperm concentration
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Lipshultz, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270841
- Sponsor's protocol ID
- ZA-203
- Status last verified
- Jun 2014
- First submitted
- 4 Jan 2011
- Last updated
- 28 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25044085