- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03662958
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
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
- Name: Hongju Wang, MD
- Phone Number: 0552-3086026
- Email: wanghongju@bbmu.edu.cn
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:
- 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
Exclusion Criteria:
- 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
- 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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZK-LUT-201802
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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