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Comparison of a Novel Leuprolide With Market Leuprolide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662958
Recruitment Status : Unknown
Verified September 2018 by Lee's Pharmaceutical Limited.
Recruitment status was:  Recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Lutrate Drug: Enantone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lutrate
a novel leuprolide acetate 3.75mg depot
Drug: Lutrate
a novel leuprolide acetate 3.75mg depot

Active Comparator: Enantone
market reference leuprolide acetate 3.75 mg depot
Drug: Enantone
market reference leuprolide acetate 3.75 mg depot




Primary Outcome Measures :
  1. The rate of castration at the end of week 4 (i.e. day 29) [ Time Frame: 4 weeks ]

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

Other Outcome Measures:
  1. Adverse events [ Time Frame: 4 weeks ]
  2. 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.

  3. AE [ Time Frame: 4 weeks ]
  4. blood pressure [ Time Frame: 4 weeks ]
  5. pulse rate [ Time Frame: 4 weeks ]
  6. respiratory rate [ Time Frame: 4 weeks ]
  7. body temperature [ Time Frame: 4 weeks ]
  8. 12-lead ECG [ Time Frame: 4 weeks ]
  9. body weight [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662958


Contacts
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Contact: Hongju Wang, MD 0552-3086026 wanghongju@bbmu.edu.cn

Locations
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China, Anhui
The First Affiliated Hospital of Bengbu Medical College Recruiting
Bengbu, Anhui, China
Sponsors and Collaborators
Lee's Pharmaceutical Limited
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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT03662958    
Other Study ID Numbers: ZK-LUT-201802
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents