Status:
COMPLETED
An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)
Lead Sponsor:
Organon and Co
Conditions:
Infertility
Eligibility:
FEMALE
18-38 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Good physical and mental health;
- Body Mass Index between 18 and 29 kg/m\^2;
- Good venous accessibility;
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2000
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00647933
Start Date
June 1 2000
End Date
December 1 2000
Last Update
February 3 2022
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