Comparison of a Novel Leuprolide With Market Leuprolide

September 5, 2018 updated by: Lee's Pharmaceutical Limited

Evaluation of the Testosterone Suppressive Effect in Healthy Male Volunteers of a Novel Leuprolide Acetate 3.75mg Depot (Lutrate) VS Market Reference Leuprolide Acetate 3.75mg Depot (Enantone)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Anhui
      • Bengbu, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. 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.
  2. Body weight of at least 50kg. BMI to be 19-24 kg/m2 (inclusive).
  3. 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
  4. Signed informed consent form prior to any screening procedures

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lutrate
a novel leuprolide acetate 3.75mg depot
a novel leuprolide acetate 3.75mg depot
Active Comparator: Enantone
market reference leuprolide acetate 3.75 mg depot
market reference leuprolide acetate 3.75 mg depot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of castration at the end of week 4 (i.e. day 29)
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The time to castration (i.e Tlag) between the 2 groups after administration of leuprolide
Time Frame: 4 weeks
4 weeks
The duration of castration (i.e Tcast)
Time Frame: 4 weeks
4 weeks
LH concentration
Time Frame: 4 weeks
4 weeks
FSH concentration
Time Frame: 4 weeks
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 4 weeks
4 weeks
Local tolerability
Time Frame: post-dose 5 min and 1 hour, day 8, 15 and 29
(10) Subjects will evaluate pain with VAS. Investigators will evaluate redness and induration with a 4-point scale.
post-dose 5 min and 1 hour, day 8, 15 and 29
AE
Time Frame: 4 weeks
4 weeks
blood pressure
Time Frame: 4 weeks
4 weeks
pulse rate
Time Frame: 4 weeks
4 weeks
respiratory rate
Time Frame: 4 weeks
4 weeks
body temperature
Time Frame: 4 weeks
4 weeks
12-lead ECG
Time Frame: 4 weeks
4 weeks
body weight
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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