TriangleNCT03242590 · CITED IN SOURCE DOCUMENTS
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2019-10-23
Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- 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).
- healthy Volunteers
- false
- maximum Age
- 80 Years
- minimum Age
- 18 Years
- sex
- MALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day.
- intervention Names
- Drug: LPCN 1021
- label
- Oral testosterone undecanoate, LPCN 1021
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Oral testosterone undecanoate, LPCN 1021
- description
- Oral testosterone undecanoate
- name
- LPCN 1021
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 95
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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).
- measure
- Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range
- time Frame
- Following 24 days of treatment
Full study description
- brief Summary
- Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
Source references
- references
- citation
- DelConte A, Papangkorn K, Kim K, Bruno BJ, Chidambaram N, Khera M, Goldstein I, Kohler TS, Miner M, Dobs AS, Patel MV. A new oral testosterone (TLANDO) treatment regimen without dose titration requirement for male hypogonadism. Andrology. 2022 May;10(4):669-676. doi: 10.1111/andr.13153. Epub 2022 Jan 18.
- pmid
- 34994093
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- clinical indication matching status
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- occurrences
- context exact
- LINICAL STUDIES The efficacy and safety of TLANDO was evaluated in Study 16-002 a multicenter, open-label, single-arm study in adult hypogonadal male patients (NCT03242590). Patients received TLANDO 225 mg, orally twice daily with food for approximately 24 days; no titration was performed to adjust the dosage. A total of 95 hypog
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Preserved source evidence · Not medical advice