Uterine fibroids (Uterus myomatosus) MedDRA version: 8.0 Level: LLT Classification code 10046784
Conditions
Interventions
Trade Name: Leuplin for injection 3,75
Pharmaceutical Form: Injection*
INN or Proposed INN: leuprorelinacetat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.75-
Sponsors
Takeda Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed