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

NCT00776074 | Completed Phase 2

• 4 other identifiers: ENG K001 GF2005-005641-19EC 406U1111-1114-2217
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Uterine Fibroids

Keywords

Leiomyoma; Uterine Fibroids; Drug Therapy; Uterine Neoplasms; Fibroid Tumor

Outcome Measures

Primary Outcomes (1)

• Percentage of measured E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL.

  Weeks 5 through Final Visit.

Secondary Outcomes (3)

• Time course of E2 (17β-estradiol) Serum Concentration levels.

  At all Visits.

• Time course of E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL.

  Week 5 through Final Visit.

• Rate of E2 (17β-estradiol) Serum Concentration levels less than or equal to 50, 40 and 30 ng/dL.

  At all Visits.

Study Arms (2)

Leuprorelin (GF)

EXPERIMENTAL

Drug: Leuprorelin (GF)

Leuprorelin (GC)

EXPERIMENTAL

Drug: Leuprorelin (GC)

Interventions

Leuprorelin (GF) DRUG

Leuprorelin (GF) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.

Also known as: Leuplin, Enantone, Trenantone, TAP-144SR

Leuprorelin (GF)

Leuprorelin (GC) DRUG

Leuprorelin (GC) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.

Also known as: Leuplin, Enantone, Trenantone, TAP-144SR

Leuprorelin (GC)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Leiomyoma; Uterine Neoplasms

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Medical Director

  Takeda Pharma Gmbh, Aachen (Germany)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 20, 2008
• Study Start: June 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: June 22, 2010

Record last verified: 2010-06