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This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral testosterone undecanoate, LPCN 1021 | Experimental | Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPCN 1021 | Drug | Oral testosterone undecanoate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range | Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration [Cavg] in the normal range | Following 24 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony DelConte, MD | Lipocine Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Testosterone Undecanoate, LPCN 1021 | Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day LPCN 1021: Oral testosterone undecanoate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Testosterone Undecanoate, LPCN 1021 | Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day LPCN 1021: Oral testosterone undecanoate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range | Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration [Cavg] in the normal range | Safety Set | Posted | Number | 95% Confidence Interval | Percent of participants | Following 24 days of treatment |
|
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Testosterone Undecanoate, LPCN 1021 | Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day LPCN 1021: Oral testosterone undecanoate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema Peripheral | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nachiappan Chidambaram, Vice President, Product Development | Lipocine, INC. | 8018819495 | nc@lipocine.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2017 | Aug 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005058 | Eunuchism |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D043343 | Testosterone Propionate |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Testosterone Value (ng/dL) | Mean | Standard Deviation | ng/dL |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 9 |
| 100 |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Hyperhidrosis | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Tooth Fracture | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Hypertension | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
|
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |