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
- Conditions
- terine fibroids (Uterus myomatosus)MedDRA version: 8.0Level: LLTClassification code 10046784
- Registration Number
- EUCTR2005-005641-19-DE
- Lead Sponsor
- Takeda Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Normotensive female patients with ultrasound confirmed uterine fibroids with body mass index (BMI) in the range 18 - 28; deemed otherwise healthy on the basis of a clinical history, physical examination, and laboratory tests of blood and urine; able to give fully informed written consent; mid-luteal phase E2, progesterone, FSH and LH results within the normal range; regular menstruation (except for symptoms of fibroids)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Pregnancy, nursing or lactating mothers; positive tests for hepatitis B & C, HIV 1 & 2; severe adverse reaction to any drug; sensitivity to study medication; drug or alcohol abuse; smoking of more than 10 cigarettes daily; participation in other clinical studies of unlicensed medicines, anaemia or loss of more than 400 mL blood within the previous 3 months; having received blood products in the previous 6 months; vital signs outside the acceptable range; clinically relevant abnormal findings at the screening assessment; acute or chronic illness; clinically relevant abnormal medical history or concurrent medical condition; possibility that patient will not co-operate; use of oral contraceptives and other drugs affecting production, activity or assay of sex steroids
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare TAP-144SR (gelatine free) with the existing TAP-144SR formulation, with respect to safety, tolerability, pharmacokinetics and pharmacodynamics in women;Secondary Objective: none;Primary end point(s): Percentage of measured E2 concentrations less then or equal to 30 pg/mL from day 35 to the end of the study
- Secondary Outcome Measures
Name Time Method