An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00647933
First received: March 27, 2008
Last updated: October 2, 2009
Last verified: October 2009
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Purpose
The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: Org 36286 (corifollitropin alfa) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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®. |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 24 |
| Study Start Date: | June 2000 |
| Study Completion Date: | December 2000 |
| Primary Completion Date: | December 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Lyndiol® / Org 36286 (corifollitropin alfa)
|
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.
|
|
Experimental: 2
Lyndiol® / Org 36286 (corifollitropin alfa)
|
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.
|
|
Experimental: 3
Lyndiol® / Org 36286 (corifollitropin alfa)
|
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.
|
|
Experimental: 4
Lyndiol® / Org 36286 (corifollitropin alfa)
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 38 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00647933 History of Changes |
| Other Study ID Numbers: | 38802 |
| Study First Received: | March 27, 2008 |
| Last Updated: | October 2, 2009 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Schering-Plough:
|
Females Corifollitropin alfa Antibodies Pharmacokinetics Pharmacodynamics |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Noracycline Contraceptives, Oral, Combined Contraceptives, Oral |
Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013