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

February 1, 2022 updated by: Organon and Co

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®.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Org 36286 15 μg + Lyndiol®
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
Subcutaneous Org 36286
Other Names:
  • Corifollitropin alfa
Drug: Lyndiol®
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
Experimental: Org 36286 30 μg + Lyndiol®
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
Subcutaneous Org 36286
Other Names:
  • Corifollitropin alfa
Drug: Lyndiol®
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
Experimental: Org 36286 60 μg + Lyndiol®
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
Subcutaneous Org 36286
Other Names:
  • Corifollitropin alfa
Drug: Lyndiol®
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
Experimental: Org 36286 120 μg + Lyndiol®
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
Subcutaneous Org 36286
Other Names:
  • Corifollitropin alfa
Drug: Lyndiol®
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum number of follicles >= 5 mm (nmax)
Time Frame: Days 2 - 35
Days 2 - 35
Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286
Time Frame: Days 1 - 15
Days 1 - 15
Mean dose-normalized area under the curve (AUC) post single dose Org 36286
Time Frame: Days 1 - 15
Days 1 - 15
Mean total plasma clearance (CL) post single dose Org 36286
Time Frame: Days 1 - 15
Days 1 - 15
Number of participants with an adverse event (AE)
Time Frame: Start of treatment up to day 28
Start of treatment up to day 28

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

December 1, 2000

Study Completion (Actual)

December 1, 2000

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P07004
  • 38802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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