An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)

An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 After a Single Subcutaneous Dose in Healthy Female Volunteers Whose Pituitary Function is Suppressed by Lyndiol®.

The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.

Inclusion Criteria:

• Good physical and mental health;
• Body Mass Index between 18 and 29 kg/m^2;
• Good venous accessibility;

Exclusion Criteria:

• Clinically relevant abnormal blood chemistry, hematology and/or urinalysis at screening;
• Hypertension (sitting diastolic blood pressure > 90 mmHg and/or systolic blood pressure > 150 mmHg);
• Contraindications for the use of oral contraceptives or gonadotropins;
• PAP-smear (= III) according to the Papanicolaou classification;
• History of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or any evidence of ovarian dysfunction;
• Primary ovarian failure;
• Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease;
• Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation;
• Ovarian surgery;
• Smoking more than 10 cigarettes or equivalents a day;
• History (within 12 months) of alcohol or drugs abuse;
• Blood donation (> 200 ml) within 90 days prior to screening;
• Administration of investigational drugs within 90 days prior to start Org 36286.