Comparison of a Novel Leuprolide With Market Leuprolide

NCT03662958 | Unknown

• 1 other identifier: ZK-LUT-201802
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single dose, randomized, single blind, parallel group study to evaluate the testosterone suppressive effect in healthy male volunteers of a novel leuprolide acetate 3.75mg depot vs market reference leuprolide acetate 3.75mg depot. The safety, tolerability and the pharmacokinetic properties of the investigational drug and the control drug will also be assessed.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The rate of castration at the end of week 4 (i.e. day 29)

  4 weeks

Secondary Outcomes (4)

• The time to castration (i.e Tlag) between the 2 groups after administration of leuprolide

  4 weeks

• The duration of castration (i.e Tcast)

  4 weeks

• LH concentration

  4 weeks

• FSH concentration

  4 weeks

Other Outcomes (9)

• Adverse events

  4 weeks

• Local tolerability

  post-dose 5 min and 1 hour, day 8, 15 and 29

• AE

  4 weeks

Study Arms (2)

Lutrate

EXPERIMENTAL

a novel leuprolide acetate 3.75mg depot

Drug: Lutrate

Enantone

ACTIVE COMPARATOR

market reference leuprolide acetate 3.75 mg depot

Drug: Enantone

Interventions

Lutrate DRUG

a novel leuprolide acetate 3.75mg depot

Lutrate

Enantone DRUG

market reference leuprolide acetate 3.75 mg depot

Enantone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males of 18-40 years old (inclusive). The age difference of subjects within and between groups should be less than 10 years, at the time of screening.
• Body weight of at least 50kg. BMI to be 19-24 kg/m2 (inclusive).
• Able to comprehend the full nature and purpose of the study, including potential risks and side effects; able to cooperate with investigators and to comply with the requirements of the study
• Signed informed consent form prior to any screening procedures

You may not qualify if:

• Clinically significant and relevant history of cardiovascular, hepatic, renal, hematologic, endocrine, respiratory, neurological diseases or acute/chronic diseases of the digestive tract.
• History of hypersensitivity towards leuprolide, synthetic LHRH or LHRH derivatives or any excipients of the study formulation.
• Abnormal and clinically significant 12-lead ECG
• Abnormal and clinically significant laboratory assessments
• Blood donation or blood loss greater than or equal to 400mL within 3 months prior to screening
• Participation of clinical trials within 3 months prior to screening
• Use of any drugs within 2 weeks prior to screening
• History of drug abuse within 1 year prior to screening
• History of alcohol abuse within 1 years prior to screening
• History of tobacco smoking (more than 5 cigarette per day) within 1 year prior to screening
• Abnormal testosterone level at screening (not in the range of 168-781ng/dL)
• Dermatitis or skin anomalies that might affect the administration area and the surroundings
• Subject or his partner not willing to adopt appropriate contraceptive measures
• Subjects have a history of depressive illness or sexual dysfunction;
• Subjects that the investigator deems unsuitable to be enrolled

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Hongju Wang, MD

CONTACT

0552-3086026; wanghongju@bbmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 10, 2018
• Study Start: August 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

CN (1)