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

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

Official Title
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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®.

Conditions
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Infertility

Intervention / Treatment
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* Drug: Org 36286
* Drug: Lyndiol®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Org 36286 15 μg + Lyndiol®<br>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. | Drug: Org 36286<br>* Subcutaneous Org 36286<br>* Other names: Corifollitropin alfa;Drug: Lyndiol®<br>* Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.<br>* Other names: 50 μg ethinylestradiol + 2.5 mg lynestrenol;|
| Experimental: Org 36286 30 μg + Lyndiol®<br>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. | Drug: Org 36286<br>* Subcutaneous Org 36286<br>* Other names: Corifollitropin alfa;Drug: Lyndiol®<br>* Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.<br>* Other names: 50 μg ethinylestradiol + 2.5 mg lynestrenol;|
| Experimental: Org 36286 60 μg + Lyndiol®<br>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. | Drug: Org 36286<br>* Subcutaneous Org 36286<br>* Other names: Corifollitropin alfa;Drug: Lyndiol®<br>* Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.<br>* Other names: 50 μg ethinylestradiol + 2.5 mg lynestrenol;|
| Experimental: Org 36286 120 μg + Lyndiol®<br>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. | Drug: Org 36286<br>* Subcutaneous Org 36286<br>* Other names: Corifollitropin alfa;Drug: Lyndiol®<br>* Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.<br>* Other names: 50 μg ethinylestradiol + 2.5 mg lynestrenol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corifollitropin alfa, Pharmacokinetics, Pharmacodynamics, Females, Antibodies