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®.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00647933

Enrollment

Registered

2008-04-01

Start date

2000-06-30

Completion date

2000-12-31

Last updated

2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Females, Corifollitropin alfa, Antibodies, Pharmacokinetics, Pharmacodynamics

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.

Interventions

DRUGOrg 36286

Subcutaneous Org 36286

DRUGLyndiol®

Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 38 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Mean dose-normalized maximum plasma concentration (Cmax) 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
Maximum number of follicles >= 5 mm (nmax)	Days 2 - 35
Mean dose-normalized area under the curve (AUC) post single dose Org 36286	Days 1 - 15

Secondary

Measure	Time frame
Total number of follicles >= 5 mm per day	Days 2 - 35
Day on which the number of follicles >= 5 mm was equal to nmax for the first time (dmax)	Days 2 - 35

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026