Only healthy volunteers will participate in this clinical trial. Intended indication: contraception.
Conditions
Interventions
Product Name: Estetrol
Product Code: E4
Pharmaceutical Form: Oral solution
Trade Name: Cerazette
Pharmaceutical Form: Coated tablet
Trade Name: Progestan
Pharmaceutical Form: Capsule*
Trade Name: O
Sponsors
Pantarhei Bioscience BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • At least 18 years and not older than 40 years of age • Willing to use a barrier method of contraception during the wash-out cycle, the pre-treatment cycle, the period of study drug administration, the period of lynestrenol intake (if applicable), and 14 days thereafter or until the follow-up visit if this 14-days period ends before the follow-up visit. • Women who ovulate in the pre-treatment cycle before or on day 24 (±1) after start of their menses, who have a subsequent P concentration of above 16 nmol/l and whose next menstruation does not start within 7 days after ovulation • Body Mass Index between 18 and 30 kg/m2 • Good physical and mental health • Both ovaries visible upon ultrasonography • Willing to give informed consent in writing Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Clinically significant abnormal results of routine hematology, serum biochemistry, urinanalysis, and/or ECG in the opinion of the Investigator at screening. • Known or suspected pregnancy • Lactation • Known or suspected breast cancer or a history of breast cancer • Clinically significant abnormalities of the uterus and/or ovaries detected by examination and/or ultrasound (non-physiological ovarian mass or significant uterine pathology). • A cervical smear with clinically relevant abnormal cytology within one year before study start. • Previous use of depot progestogen preparations in the last 6 months. • Contraindications for contraceptive steroids: - a history of, or existing thromboembolic, cardiovascular or cerebrovascular disorder - a history of, or existing conditions predisposing to, or being prodromi of, a thrombosis - a known defect in the blood coagulation system (e.g. deficiencies in AT-III, protein C, S, and APC resistance) - heterozygous for a mutation in coagulation factor II and/or positive for factor V Leiden - the presence of a severe or more than one risk factor for vascular disease (e.g. dyslipoproteinaemia; diabetes mellitus; hyperhomocysteinaemia; systemic lupus erythematosus; chronic inflammatory bowel disease; antiphospholipid antibodies; smoking; venous thromboembolism in sibling or parent below the age of 50, or arterial disease in sibling or parent below the age of 35; within 2 weeks after full remobilisation following surgery) - hypertension, i.e. systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg - disturbance of liver function: e.g. cholestatic jaundice, a history of jaundice of pregnancy or jaundice due to previous oestrogen use, Rotor syndrome and Dubin-Johnson syndrome - known or suspected hormone-dependent tumours or endometrial hyperplasia - undiagnosed vaginal bleeding - porphyria - a history during pregnancy or previous hormone-use of severe pruritus, herpes gestationis or deterioration of otosclerosis • Use of one or more of the following medications: - sex steroids other than the medication of study - use at present or within 2 months before start study medication: - hydantoins, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, troglitazone, felbamate, rifampicin, rifabutin, griseofulvin and St. John’s wort (Hypericum perforatum) • Status post-partum or post-abortion within a period of 2 months before study start • Administration of investigational drugs within 3 months before start study medication • A history of (within 12 months) alcohol or drug abuse • A known hypersensitivity for one of the components of the study medication (eg arachisoil and lactosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To investigate ovarian suppression and ovulation inhibition • To evaluate hypothalamic-pituitary-ovarian function • To evaluate the vaginal bleeding pattern • Pharmacokinetics of E4 • Safety/tolerability;Secondary Objective: ;Primary end point(s): | — |
Countries
Netherlands
Outcome results
None listed