Male Hypogonadism
Conditions
Keywords
Testosterone, Male hypogonadism, Low testosterone, LPCN 1021, Androgel, Testim, Testopel, Fortesta, Axiron., Hypogonadism, Eunuchism, Gonadal Disorders, Endocrine System Diseases, Testosterone enanthate, Testosterone undecanoate, Testosterone 17 beta-cypionate, Methyltestosterone, Androgens, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Pharmacologic Actions, Antineoplastic Agents, Hormonal, Antineoplastic Agents, Anabolic Agents
Brief summary
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
Interventions
DRUGOral testosterone undecanoate, LPCN 1021
DRUGTopical testosterone gel 1.62 %
Sponsors
Syneos Health
PPD Development, LP
Lipocine Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). 2. Serum total testosterone \< 300 ng/dL based on 2 consecutive blood samples
Exclusion criteria
A subject will not be eligible for study participation if he meets any of the following criteria. 1. History of significant sensitivity or allergy to androgens, castor oil or product excipients. 2. Clinically significant findings in the prestudy examinations. 3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS score \> 19 points. 4. Body mass index (BMI) ≥ 38 kg/m2. 5. Clinically significant abnormal laboratory values 6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus antibodies (HIV Ab). 7. History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures. 8. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption. 9. History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration. 10. History of stroke or myocardial infarction within the past 5 years. 11. History of, or current or suspected, prostate or breast cancer. 12. History of diagnosed, severe, untreated, obstructive sleep apnea. 13. History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years. 14. History of long QT syndrome or unexplained sudden death in a first degree relative (parent, sibling, or child). 15. Concurrent treatment with medications which may impact the absorption, distribution, metabolism or excretion of testosterone undecanoate (TU) or place the subject at risk for treatment with testosterone. 16. Subject has a partner who is currently pregnant or planning pregnancy during the course of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL. | Following 13 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of LPCN 1021-treated subjects with maximum serum T concentrations (Cmax) values that are (a) less than 1500 ng/dL; (b) between 1800 and 2500 ng/dL, and (c) greater than 2500 ng/dL | Following 13 weeks of treatment |
| Change from baseline in patient reported outcomes for LPCN 1021 (i.e., International Prostate Symptom Score [I-PSS], Psychosexual Daily Questionnaire [PDQ], Short Form-36 Questionnaire [SF-36]) | 52 weeks |
| Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA) | 52 weeks |
| Number of subjects with adverse events during 52 weeks of treatment | 52 weeks |
Outcome results
None listed