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

Organon

Status and phase: Completed; Phase 1

Conditions: Infertility

Treatments: Drug: Lyndiol®; Drug: Org 36286

Study type: Interventional

Funder types: Industry

Identifiers

NCT00647933

P07004

38802

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Org 36286 15 μg + Lyndiol®

Experimental group

Description:

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.

Treatment:

Drug: Org 36286

Drug: Lyndiol®

Org 36286 30 μg + Lyndiol®

Experimental group

Description:

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.

Treatment:

Drug: Org 36286

Drug: Lyndiol®

Org 36286 60 μg + Lyndiol®

Experimental group

Description:

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.

Treatment:

Drug: Org 36286

Drug: Lyndiol®

Org 36286 120 μg + Lyndiol®

Experimental group

Description:

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.

Treatment:

Drug: Org 36286

Drug: Lyndiol®