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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lutrate | Experimental | a novel leuprolide acetate 3.75mg depot |
|
| Enantone | Active Comparator | market reference leuprolide acetate 3.75 mg depot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutrate | Drug | a novel leuprolide acetate 3.75mg depot |
| |
| Enantone |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of castration at the end of week 4 (i.e. day 29) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The time to castration (i.e Tlag) between the 2 groups after administration of leuprolide | 4 weeks | |
| The duration of castration (i.e Tcast) | 4 weeks | |
| LH concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 4 weeks | |
| Local tolerability | (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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongju Wang, MD | Contact | 0552-3086026 | wanghongju@bbmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | Anhui | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
market reference leuprolide acetate 3.75 mg depot |
|
| 4 weeks |
| FSH concentration | 4 weeks |
| AE | 4 weeks |
| blood pressure | 4 weeks |
| pulse rate | 4 weeks |
| respiratory rate | 4 weeks |
| body temperature | 4 weeks |
| 12-lead ECG | 4 weeks |
| body weight | 4 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |