Phase 3
N=499
Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Secondary Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT01534208 ↗Enrolled (actual)
499
Serious AEs
3.1%
Results posted
Jul 2014
Primary outcome: Primary: Change From Baseline in Total Morning Testosterone at 26 Weeks — 280.9; 214.7 ng/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Androxal (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Repros Therapeutics Inc.
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Morning Testosterone at 26 Weeks |
280.9; 214.7 | — |
| PRIMARY Change From Baseline in LH |
4.81; 4.27 | — |
| PRIMARY Absolute Values of Morning Testosterone |
511.6; 416.7 | — |
| PRIMARY Mean Change From Baseline FPG |
-5.4; -5.0 | — |
| PRIMARY Change From Baseline in BMI |
0.2; 0.3 | — |
| PRIMARY Change From Baseline in FSH |
5.20; 5.42 | — |
Summary
ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.
Eligibility Criteria
Inclusion Criteria
- Secondary hypogonadal males between the ages of 18 and 65
- Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1.
- 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 with morning testosterone level 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, 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 known hyperprolactinemia with or without a tumor
- Chronic use of medications use such as glucocorticoids
- Chronic use of narcotics
- Subjects know to be positive for HIV
- End stage renal disease
- Subjects with cystic fibrosis (mutation of the CFTR gene)
- Enrollment in a previous Androxal study
Data sourced from ClinicalTrials.gov (NCT01534208). 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.