Phase 2
N=124
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
Secondary Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT01270841 ↗Enrolled (actual)
124
Serious AEs
0.8%
Results posted
Jul 2014
Primary outcome: Primary: Change in Total Morning Testosterone — -16.9; 253.7; 258.5; 197.3 ng/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); topical testosterone (Drug); Androxal (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Male
- Sponsor
- Repros Therapeutics Inc.
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Morning Testosterone |
-16.9; 253.7; 258.5; 197.3 | — |
| SECONDARY Change in Luteinizing Hormone Levels |
-0.1; -2.4; 4.8; 6.9 | — |
| SECONDARY Change in FSH After 3 Months of Treatment |
-0.2; -4.4; 5.1; 7.4 | — |
| SECONDARY Reproductive Safety |
-19.1; -29.5; 8.2; -2.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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
- 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
Data sourced from ClinicalTrials.gov (NCT01270841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.