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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04914195
Other study ID # BSV_LEUPR_18_05
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 1, 2021
Est. completion date September 29, 2022

Study information

Verified date July 2023
Source Bharat Serums and Vaccines Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3 clinical study to compare the efficacy, safety, and pharmacokinetics of leuprolide acetate for injection 3.75mg (depot) of two brands (Luprodex and Lucrin) administered in subjects with advanced adenocarcinoma of the prostate. Approximately 168 subjects (males )of age above 18 years fulfilling the eligibility criteria will be enrolled. The IP will be given as a monthly dose for two cycles on day 0 and day 28. The pharmacokinetic analysis will be done for 12 patients receiving Luprodex. The primary and secondary outcomes will be captured on days as per protocol. Adverse events will be noted for safety evaluation.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Leuprolide Acetate 3.75 MG/ML
Leuprolide Acetate/ Leuprorelin is a depot injection administered as a subcutaneous injection once every month.

Locations

Country Name City State
India MV hospital and Research Center Lucknow Uttar Pradesh
India Government Med ical College & Superspeciality Hospital Nagpur Nagpur Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Bharat Serums and Vaccines Limited

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Testosterone response rate defined as Testosterone values sustained below castration level (0.5 ng/mL or 50 ng/dL) i.e. all Testosterone values at and after Day 28 until Day 57 must be < 0.5 ng/mL or < 50 ng/dL From Day 28 to day 57
Secondary Percentage of subjects who have reached castration level of Testosterone at the last visit (Day 57) Day 57
Secondary Percentage of breakthrough responses defined as a single total serum Testosterone value of >0.5 ng/mL or >50 ng/dL measured after achieving a castration Testosterone level from Day 28 to Day 57
Secondary Time after first implantation until castration level of Testosterone is achieved up to Day 28
Secondary Percentage of subjects with Testosterone values sustained below 0.2 ng/mL or 20 ng/dL at and after Day 28 until Day 57 From Day 28 to Day 57
Secondary Change from baseline in Luteinizing hormone (LH) levels at Day 28 and 57 from baseline to Day 28 and from baseline to Day 57
Secondary Change from baseline in Follicle Stimulating Hormone (FSH) levels at Day 28 and Day 57 from baseline to Day 28 and from baseline to Day 57
Secondary Change from baseline in Prostate-specific antigen (PSA) at Day 57 Day 57
Secondary Mean number of days of maintaining testosterone castration levels (mean number of castration days) day 28 to day 57
Secondary Mean maximum testosterone concentration during the dosing period after reaching the castration level Day 28 to Day 57
See also
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Terminated NCT04843319 - To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer Phase 1/Phase 2