Ignite Creation Date:
2024-05-05 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00776074
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2008-10-16
Brief Title:
A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
3 Months Open-Label Parallel-Group Study of the Pharmacodynamics Pharmacokinetics and Safety of TAP-144SR 1-month Depot Gelatin-Free vs Gelatin-Containing Formulation in Female Patients With Uterine Fibroids
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation GF to leuprorelin gelatin containing formulation GC in female subjects with uterine fibroids
Detailed Description:
Gonadotropin-releasing hormone also called luteinizing hormone releasing hormone is a neuropeptide hormone released from the hypothalamus Gonadotropin-releasing hormone binds to specific gonadotropin-releasing hormone receptors in the cell membrane of pituitary gland cells inducing the cells to produce and release the gonadotropins luteinizing hormone and follicle-stimulating hormone Luteinizing hormone and follicle-stimulating hormone are released into the general circulation and stimulate the gonads to produce and release the sex steroids testosterone and estrogen Follicle-stimulating hormone also controls gametogenesis
Suppression of gonadotropin secretion is an effective treatment for conditions such as prostate cancer endometriosis and central precocious puberty because these conditions respond to manipulation of the sex steroids Suppression of gonadotropin secretion can be achieved by administration of gonadotropin-releasing hormone agonists that after an initial transient stimulation of gonadotropin release reversibly desensitize pituitary gonadotropin-releasing hormone receptors Desensitization is thought to occur by down-regulation of the numbers of gonadotropin-releasing hormone receptors and uncoupling of the receptors from the biochemical pathway that leads to gonadotropin release Termination of gonadotropin-releasing hormone agonist administration reverses the desensitization and gonadotropin and sex hormone levels return to normal
There are several marketed gonadotropin-releasing hormone agonists one of which is TAP-144 leuprorelin an active synthetic nonapeptide gonadotropin-releasing hormone analogue In the present study the existing leuprorelin 1- month sustained release formulation will be compared with a new gelatin-free 1-month sustained release formulation
Suppression of gonadotropin secretion is an effective treatment for conditions such as prostate cancer endometriosis and central precocious puberty because these conditions respond to manipulation of the sex steroids Suppression of gonadotropin secretion can be achieved by administration of gonadotropin-releasing hormone agonists that after an initial transient stimulation of gonadotropin release reversibly desensitize pituitary gonadotropin-releasing hormone receptors Desensitization is thought to occur by down-regulation of the numbers of gonadotropin-releasing hormone receptors and uncoupling of the receptors from the biochemical pathway that leads to gonadotropin release Termination of gonadotropin-releasing hormone agonist administration reverses the desensitization and gonadotropin and sex hormone levels return to normal
There are several marketed gonadotropin-releasing hormone agonists one of which is TAP-144 leuprorelin an active synthetic nonapeptide gonadotropin-releasing hormone analogue In the present study the existing leuprorelin 1- month sustained release formulation will be compared with a new gelatin-free 1-month sustained release formulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1114-2217 | REGISTRY | WHO | None |
| 2005-005641-19 | EUDRACT_NUMBER | None | None |
| EC 406 | OTHER | None | None |