A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Percentage of measured E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL. [ Time Frame: Weeks 5 through Final Visit. ]
- Time course of E2 (17β-estradiol) Serum Concentration levels. [ Time Frame: At all Visits. ]
- Time course of E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL. [ Time Frame: Week 5 through Final Visit. ]
- Rate of E2 (17β-estradiol) Serum Concentration levels less than or equal to 50, 40 and 30 ng/dL. [ Time Frame: At all Visits. ]
|Study Start Date:||June 2006|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
|Experimental: Leuprorelin (GF)||
Drug: Leuprorelin (GF)
Leuprorelin (GF) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.
|Experimental: Leuprorelin (GC)||
Drug: Leuprorelin (GC)
Leuprorelin (GC) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776074
|Study Director:||Medical Director||Takeda Pharma Gmbh, Aachen (Germany)|