Skip to main content
OpenTrials
Completed

NCT Number: NCT00647933

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Org 36286

Drug

Subcutaneous Org 36286

Other names: Corifollitropin alfa

Lyndiol®

Drug

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

Other names: 50 μg ethinylestradiol + 2.5 mg lynestrenol

Primary outcomes

  1. Maximum number of follicles >= 5 mm (nmax)

    Time frame: Days 2 - 35

  2. Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286

    Time frame: Days 1 - 15

  3. Mean dose-normalized area under the curve (AUC) post single dose Org 36286

    Time frame: Days 1 - 15

  4. Mean total plasma clearance (CL) post single dose Org 36286

    Time frame: Days 1 - 15

  5. Number of participants with an adverse event (AE)

    Time frame: Start of treatment up to day 28

Secondary outcomes

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

    Time frame: Days 2 - 35

  2. Total number of follicles >= 5 mm per day

    Time frame: Days 2 - 35

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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®.

Important dates

Study start
2000
Primary completion
2000
Study completion
2000
First posted
Apr 1, 2008
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.