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

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00647933

First received: March 27, 2008

Last updated: October 2, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	March 27, 2008
Last Updated Date	October 2, 2009
Start Date ^ICMJE	June 2000
Primary Completion Date	December 2000 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 26, 2008)	The primary pharmacodynamics parameter was nmax which was defined as the maximum number of follicles >= 5 mm (left and right ovary combined) measured after Org 36286 administration. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 13, 15, 17, 19, 21 and 35 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 31, 2008)	The primary pharmacodynamics parameter was nmax which was defined as the maximum number of follicles ≥ 5 mm (left and right ovary combined) measured after Org 36286 administration. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 13, 15, 17, 19, 21 and 35 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00647933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 26, 2008)	dmax which was defined as the day on which the number of follicles >= 5 mm was equal to nmax for the first time. [ Time Frame: Days 1,2, 3, 4, 5, 6, 7, 9, 11, 13, 15, 17, 19, 21, 35 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 31, 2008)	dmax which was defined as the day on which the number of follicles ≥ 5 mm was equal to nmax for the first time. [ Time Frame: Days 1,2, 3, 4, 5, 6, 7, 9, 11, 13, 15, 17, 19, 21, 35 ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (COMPLETED)
Official Title ^ICMJE	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®.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Infertility
Intervention ^ICMJE	Drug: Org 36286 (corifollitropin alfa) After a pill-free period of 7 days, all subjects started taking 1 tablet of Lyndiol® daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, the first group of 8 females was admitted to the clinic and received a single SC dose of Org 36286. The Org 36286 injection was administered subcutaneously in the abdominal wall around the umbilicus. All injections were given by the (sub-) investigator.
Study Arm (s)	Experimental: 1 Lyndiol® / Org 36286 (corifollitropin alfa) Intervention: Drug: Org 36286 (corifollitropin alfa) Experimental: 2 Lyndiol® / Org 36286 (corifollitropin alfa) Intervention: Drug: Org 36286 (corifollitropin alfa) Experimental: 3 Lyndiol® / Org 36286 (corifollitropin alfa) Intervention: Drug: Org 36286 (corifollitropin alfa) Experimental: 4 Lyndiol® / Org 36286 (corifollitropin alfa) Intervention: Drug: Org 36286 (corifollitropin alfa)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	24
Completion Date	December 2000
Primary Completion Date	December 2000 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: At least 18 and at most 38 years of age at the time of screening; Good physical and mental health; Body Mass Index between 18 and 29 kg/m^2; Good venous accessibility; Able and willing to comply with the protocol and willing to provide written informed consent. 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.
Gender	Female
Ages	18 Years to 38 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00647933
Other Study ID Numbers ^ICMJE	38802
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top