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A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00776074
First Posted: October 20, 2008
Last Update Posted: June 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Takeda
  Purpose
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.

Condition Intervention Phase
Uterine Fibroids Drug: Leuprorelin (GF) Drug: Leuprorelin (GC) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of measured E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL. [ Time Frame: Weeks 5 through Final Visit. ]

Secondary Outcome Measures:
  • 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. ]

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
Experimental: Leuprorelin (GF) Drug: Leuprorelin (GF)
Leuprorelin (GF) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Other Names:
  • Leuplin
  • Enantone
  • Trenantone
  • TAP-144SR
Experimental: Leuprorelin (GC) Drug: Leuprorelin (GC)
Leuprorelin (GC) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Other Names:
  • Leuplin
  • Enantone
  • Trenantone
  • TAP-144SR

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients with measurable uterine fibroids confirmed by vaginal or abdominal ultrasound, deemed otherwise healthy.
  • A body mass index in the range 18 to 28.
  • Oestradiol, progesterone, luteinizing hormone and follicle stimulating hormone results within the range of normal ovarian function.
  • Regular menstruation (except for symptoms of fibroids).
  • Females of childbearing potential who are sexually active must agree to use barrier contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

  • Acute pelvioperitonitis, ovarian cysts, persistent corpus luteum.
  • History of bilateral oophorectomy, hysterectomy, or hypophysectomy.
  • Clinically relevant abnormal history, physical findings, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the patient.
  • Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the patient participation in the study or make it unnecessarily hazardous.
  • Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
  • Presence or history of severe adverse reaction to any drug.
  • Participation in other clinical studies of a new chemical entity or a prescription medicine within the previous 3 months.
  • Presence or history of drug or alcohol abuse, or smoking of more than 10 cigarettes daily.
  • Evidence of drug abuse on urine testing.
  • Positive test for hepatitis B, hepatitis C, human immune deficiency virus 1 or human immune deficiency virus 2.
  • Severe bleedings from fibroids.
  • Anemia (hemoglobin less than 11 g/dL), loss of more than 400 mL blood during the 3 months before the study.
  • Use of oral contraceptives or other estrogen containing medication, progestins, danazol, progesterone antagonists, antiandrogens, steroids or gonadotropins which might affect sex steroid production or activity or assay (e.g. norethindrone) within 30 days prior to study enrolment.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776074


Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda Pharma Gmbh, Aachen (Germany)
  More Information

Responsible Party: Medical Director, Takeda Pharma Gmbh, Aachen (Germany)
ClinicalTrials.gov Identifier: NCT00776074     History of Changes
Other Study ID Numbers: ENG K001 GF
2005-005641-19 ( EudraCT Number )
EC 406 ( Other Identifier: Takeda ID )
U1111-1114-2217 ( Registry Identifier: WHO )
First Submitted: October 16, 2008
First Posted: October 20, 2008
Last Update Posted: June 22, 2010
Last Verified: June 2010

Keywords provided by Takeda:
Leiomyoma
Uterine Fibroids
Drug Therapy
Uterine Neoplasms
Fibroid Tumor

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents