Hypogonadism, Male
Conditions
Brief summary
Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
Interventions
DRUGLPCN 1021
Oral testosterone undecanoate
Sponsors
Lipocine Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy. 2. Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired). 3. Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.
Exclusion criteria
1. History of significant sensitivity or allergy to androgens, or product excipients. 2. Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up. 3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s). 4. Subjects with symptoms of moderate to severe benign prostatic hyperplasia. 5. Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis 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 gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption. 8. History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration. 9. History of stroke or myocardial infarction within the past 5 years. 10. History of or current or suspected prostate or breast cancer. 11. History of untreated and severe obstructive sleep apnea. 12. History of long QT syndrome (QTc \> 450) or unexplained sudden death in a first degree relative (parent, sibling, or child).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range | Following 24 days of treatment | The primary efficacy endpoint and analysis for this study was the percentage of LPCN 1021 treated subjects who had achieved a 24-hour average serum T concentration within the normal range of 300 to 1080 ng/dL at Visit 4, (Day 24 ± 4 days). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oral Testosterone Undecanoate, LPCN 1021 Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day.
LPCN 1021: Oral testosterone undecanoate | 95 |
| Total | 95 |
Baseline characteristics
| Characteristic | Oral Testosterone Undecanoate, LPCN 1021 |
|---|---|
| Age, Continuous | 56.0 years STANDARD_DEVIATION 8.9 |
| Baseline Testosterone Value (ng/dL) | 202 ng/dL STANDARD_DEVIATION 74.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 77 Participants |
| Region of Enrollment United States | 95 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 95 |
| other Total, other adverse events | 6 / 95 |
| serious Total, serious adverse events | 1 / 95 |
Outcome results
Primary
Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range
The primary efficacy endpoint and analysis for this study was the percentage of LPCN 1021 treated subjects who had achieved a 24-hour average serum T concentration within the normal range of 300 to 1080 ng/dL at Visit 4, (Day 24 ± 4 days).
Time frame: Following 24 days of treatment
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Testosterone Undecanoate, LPCN 1021 | Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range | 80 Percent of participants |