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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Org 36286
Lyndiol®
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Females, Corifollitropin alfa, Antibodies, Pharmacokinetics, Pharmacodynamics

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Org 36286 15 μg + Lyndiol®

    Org 36286 30 μg + Lyndiol®

    Org 36286 60 μg + Lyndiol®

    Org 36286 120 μg + Lyndiol®

    Arm 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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Maximum number of follicles >= 5 mm (nmax)
    Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286
    Mean dose-normalized area under the curve (AUC) post single dose Org 36286
    Mean total plasma clearance (CL) post single dose Org 36286
    Number of participants with an adverse event (AE)

    Secondary Outcome Measures

    Day on which the number of follicles >= 5 mm was equal to nmax for the first time (dmax)
    Total number of follicles >= 5 mm per day

    Full Information

    First Posted
    March 27, 2008
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00647933
    Brief Title
    An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)
    Official Title
    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®.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2000 (undefined)
    Primary Completion Date
    December 2000 (Actual)
    Study Completion Date
    December 2000 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility
    Keywords
    Females, Corifollitropin alfa, Antibodies, Pharmacokinetics, Pharmacodynamics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Org 36286 15 μg + Lyndiol®
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Org 36286 30 μg + Lyndiol®
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Org 36286 60 μg + Lyndiol®
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Org 36286 120 μg + Lyndiol®
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Org 36286
    Other Intervention Name(s)
    Corifollitropin alfa
    Intervention Description
    Subcutaneous Org 36286
    Intervention Type
    Drug
    Intervention Name(s)
    Lyndiol®
    Other Intervention Name(s)
    50 μg ethinylestradiol + 2.5 mg lynestrenol
    Intervention Description
    Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
    Primary Outcome Measure Information:
    Title
    Maximum number of follicles >= 5 mm (nmax)
    Time Frame
    Days 2 - 35
    Title
    Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286
    Time Frame
    Days 1 - 15
    Title
    Mean dose-normalized area under the curve (AUC) post single dose Org 36286
    Time Frame
    Days 1 - 15
    Title
    Mean total plasma clearance (CL) post single dose Org 36286
    Time Frame
    Days 1 - 15
    Title
    Number of participants with an adverse event (AE)
    Time Frame
    Start of treatment up to day 28
    Secondary Outcome Measure Information:
    Title
    Day on which the number of follicles >= 5 mm was equal to nmax for the first time (dmax)
    Time Frame
    Days 2 - 35
    Title
    Total number of follicles >= 5 mm per day
    Time Frame
    Days 2 - 35

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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