Prostate CancerNCT03662958
Comparison of a Novel Leuprolide With Market Leuprolide
A study testing Lutrate and Enantone in people with Prostate Cancer, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Lutrate and Enantone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
About this study
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)
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
- Being tested
- Lutrate, Enantone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LutrateDrug
a novel leuprolide acetate 3.75mg depot
EnantoneDrug
market reference leuprolide acetate 3.75 mg depot
| Study group | Role | What they receive |
|---|---|---|
| Lutrate | Experimental | a novel leuprolide acetate 3.75mg depot Receives: Drug: Lutrate |
| Enantone | Active comparator | market reference leuprolide acetate 3.75 mg depot Receives: Drug: Enantone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of castration at the end of week 4 (i.e. day 29)
Measured: 4 weeks
Secondary outcomes (4)
The time to castration (i.e Tlag) between the 2 groups after administration of leuprolide
Measured: 4 weeks
The duration of castration (i.e Tcast)
Measured: 4 weeks
LH concentration
Measured: 4 weeks
FSH concentration
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Aug 2018
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662958
- Sponsor's protocol ID
- ZK-LUT-201802
- Status last verified
- Sep 2018
- First submitted
- 30 Aug 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03662958
- Acronym / sponsor ID
- ZK-LUT-201802
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lutrate | Experimental | Drug: Lutratea novel leuprolide acetate 3.75mg depot |
| Enantone | Active comparator | Drug: Enantonemarket reference leuprolide acetate 3.75 mg depot |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutratea novel leuprolide acetate 3.75mg depot | Drug | Lutrate |
| Enantonemarket reference leuprolide acetate 3.75 mg depot | Drug | Enantone |
Primary outcome
The rate of castration at the end of week 4 (i.e. day 29)
Time frame: 4 weeks
4 secondary outcomes
The time to castration (i.e Tlag) between the 2 groups after administration of leuprolide
Time frame: 4 weeks
The duration of castration (i.e Tcast)
Time frame: 4 weeks
LH concentration
Time frame: 4 weeks
FSH concentration
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutrate and Enantone in people with Prostate Cancer, run by Lee's Pharmaceutical Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongju Wang, MD (0552-3086026, wanghongju@bbmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of castration at the end of week 4 (i.e. day 29) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.