An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)
- Registration Number
- NCT00647933
- Lead Sponsor
- Organon and Co
- Brief Summary
The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Org 36286 15 μg + Lyndiol® Lyndiol® After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 15 μg. Org 36286 30 μg + Lyndiol® Org 36286 After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 30 μg. Org 36286 30 μg + Lyndiol® Lyndiol® After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 30 μg. Org 36286 60 μg + Lyndiol® Lyndiol® After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 60 μg. Org 36286 120 μg + Lyndiol® Lyndiol® After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 120 μg. Org 36286 15 μg + Lyndiol® Org 36286 After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 15 μg. Org 36286 60 μg + Lyndiol® Org 36286 After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 60 μg. Org 36286 120 μg + Lyndiol® Org 36286 After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 120 μg.
- Primary Outcome Measures
Name Time Method Maximum number of follicles >= 5 mm (nmax) Days 2 - 35 Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286 Days 1 - 15 Mean dose-normalized area under the curve (AUC) post single dose Org 36286 Days 1 - 15 Mean total plasma clearance (CL) post single dose Org 36286 Days 1 - 15 Number of participants with an adverse event (AE) Start of treatment up to day 28
- Secondary Outcome Measures
Name Time Method Day on which the number of follicles >= 5 mm was equal to nmax for the first time (dmax) Days 2 - 35 Total number of follicles >= 5 mm per day Days 2 - 35