Safety and Efficacy of Oral LPCN 1021 in Men With Low Tes... | NCT02081300

NCT02081300

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Syneos Health	OTHER
PPD Development, LP	INDUSTRY

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral testosterone undecanoate, LPCN 1021	Experimental	Oral testosterone undecanoate: Initial dose: 225 mg TU BID. Dose titrated up to 300 mg TU BID or down to 150 mg TU BID based on serum T at Week 3 and 7.	Drug: Oral testosterone undecanoate, LPCN 1021
Topical testosterone gel 1.62 %	Other	Topical testosterone gel 1.62%: Initial dose: 40.5 mg T once daily. Dose titrated down to 20.25 mg or up to 81 mg based on serum T on Days 14 and 28	Drug: Topical testosterone gel 1.62 %

Name	Type	Description	Arm Group Labels	Other Names
Oral testosterone undecanoate, LPCN 1021	Drug		Oral testosterone undecanoate, LPCN 1021
Topical testosterone gel 1.62 %

Outcomes Module

Measure	Description	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 Outcomes

Measure	Description	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])

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
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.

History of significant sensitivity or allergy to androgens, castor oil or product excipients.
Clinically significant findings in the prestudy examinations.
Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS score > 19 points.
Body mass index (BMI) ≥ 38 kg/m2.
Clinically significant abnormal laboratory values
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).
History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
History of stroke or myocardial infarction within the past 5 years.
History of, or current or suspected, prostate or breast cancer.
History of diagnosed, severe, untreated, obstructive sleep apnea.
History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
History of long QT syndrome or unexplained sudden death in a first degree relative (parent, sibling, or child).
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.
Subject has a partner who is currently pregnant or planning pregnancy during the course of the clinical trial.

ID	Term
D005058	Eunuchism
D007006	Hypogonadism
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

ID	Term
C010792	testosterone undecanoate
D043343	Testosterone Propionate

ID	Term
D013739	Testosterone
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes