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Sponsored by: |
Takeda Pharma GmbH |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00776074 |
The purpose of this study is to determine the pharmacodynamics of TAP-144SR (gelatin free formulation) to TAP-144SR (gelatin containing formulation) in female subjects with uterine fibroids.
Condition | Intervention | Phase |
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Uterine Fibroids |
Drug: TAP-144SR (Gelatin Free) Drug: TAP-144SR (Gelatin Containing) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study |
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 |
Enrollment: | 80 |
Study Start Date: | June 2006 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: TAP-144SR (Gelatin Free)
TAP-144SR (GF) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.
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2: Experimental |
Drug: TAP-144SR (Gelatin Containing)
TAP-144SR (GC) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.
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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 (leuprolide; lupron), an active synthetic nonapeptide gonadotropin-releasing hormone analogue. In the present study, the existing gelatin-containing a 1- month sustained release formulation, TAP-144SR, will be compared with a new gelatin-free 1-month sustained release formulation, TAP-144SR (GF).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Takeda Pharma Gmbh, Aachen (Germany) ( Medical Director ) |
Study ID Numbers: | ENG K001 GF, 2005-005641-19, EC 406 |
Study First Received: | October 16, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00776074 |
Health Authority: | European Union: European Medicines Agency |
Leiomyoma Uterine Fibroids Drug Therapy Uterine Neoplasms Fibroid Tumor |
Neoplasms, Connective and Soft Tissue Myofibroma Leuprolide |
Connective Tissue Diseases Uterine Neoplasms Leiomyoma |
Neoplasms, Muscle Tissue Neoplasms Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Antineoplastic Agents Fertility Agents, Female |
Therapeutic Uses Physiological Effects of Drugs Fertility Agents Reproductive Control Agents Neoplasms, Connective Tissue Pharmacologic Actions |