Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).

Hypogonadism, Male Clinical Trial

— DV  

Official title:

Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242590
• Other study ID #: LPCN 1021-16-002
• Status: Completed
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2019
• Source: Lipocine Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: July 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male

Intervention

Drug:
• LPCN 1021
Oral testosterone undecanoate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lipocine Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Following 24 days of treatment