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

NCT00647933 | Completed Phase 1

• 2 other identifiers: P0700438802
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility

Keywords

Females; Corifollitropin alfa; Antibodies; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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

Study Arms (4)

Org 36286 15 μg + Lyndiol®

EXPERIMENTAL

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; Drug: Lyndiol®

Org 36286 30 μg + Lyndiol®

EXPERIMENTAL

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; Drug: Lyndiol®

Org 36286 60 μg + Lyndiol®

EXPERIMENTAL

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; Drug: Lyndiol®

Org 36286 120 μg + Lyndiol®

EXPERIMENTAL

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; Drug: Lyndiol®

Interventions

Org 36286 DRUG

Subcutaneous Org 36286

Also known as: Corifollitropin alfa

Org 36286 120 μg + Lyndiol®; Org 36286 15 μg + Lyndiol®; Org 36286 30 μg + Lyndiol®; Org 36286 60 μg + Lyndiol®

Lyndiol® DRUG

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

Also known as: 50 μg ethinylestradiol + 2.5 mg lynestrenol

Org 36286 120 μg + Lyndiol®; Org 36286 15 μg + Lyndiol®; Org 36286 30 μg + Lyndiol®; Org 36286 60 μg + Lyndiol®

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good physical and mental health;
• Body Mass Index between 18 and 29 kg/m\^2;
• Good venous accessibility;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Infertility

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; Noracycline; Ethinyl Estradiol; Lynestrenol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norpregnenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: June 1, 2000
• Primary Completion: December 1, 2000
• Study Completion: December 1, 2000
• Last Updated: February 3, 2022

Record last verified: 2022-02