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

• Status: Completed
• Trial end date: 2000-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ethinyl Estradiol; Lynestrenol; Mestranol; Noracycline

Criteria

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.