Only healthy premenopausal volunteers will participate in this clinical trial. Intended indication: contraception. MedDRA version: 9.1 Level: LLT Classification code 10036556 Term: Pregnancy
Conditions
Interventions
Product Name: Estetrol
Product Code: E4
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Estetrol
CAS Number: CAS 15183376
Current Sponsor code: E4
Concentration unit: mg milligram(s)
Concentra
Sponsors
Pantarhei Bioscience BV
S.A. Odyssea Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • At least 18 years and not older than 35 years of age • Willing to use a barrier method of contraception during the entire trial • Women who ovulate in the pre-treatment cycle between day 9 (± 1) and day 24 (± 1) after start of their menses and whose next menstruation does not start within 6 days after ovulation. • Body Mass Index between 18 and 30 kg/m2 • Good physical and mental health • Both ovaries visible upon vaginal 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 haematology, serum biochemistry, urinalysis, and/or ECG in the opinion of the investigator at screening. • Women with a washout cycle with a duration > 42 days • Known or suspected pregnancy • Lactation • Pregnancy during accurate hormonal contraceptive use in the past • 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 three years before study start (defined as signing of informed consent). • Previous use of depot progestogen preparations or progestogen injectables in the last 6 months. • Contraindications for contraceptive steroids • In accordance with the SmPC/Package Insert of EE/DRSP, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkaliema including hyperkaliema medication): - Renal insufficiency - Hepatic dysfunction - Adrenal insufficiency • Use of one or more of the following medications: - Antihypertensive drugs - Present use or use within 60 days prior to start of the study medication of the following drugs: phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than the study medication) and herbal remedies containing Hypericum perforatum (St John’s Wort); • Status post-partum or post-abortion within a period of 2 months before study start • Administration of investigational drugs within 2 months before screening • A history of (within 12 months) alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To investigate ovulation inhibition • To investigate pharmacodynamic effects on the liver ;Secondary Objective: • To investigate hypothalamic-pituitary-ovarian function • To investigate return of fertility • To investigate the vaginal bleeding pattern • To investigate other pharmacodynamic effects • To investigate the effect on endometrial thickness • To investigate pharmacokinetics of E4 • Safety/tolerability;Primary end point(s): | — |
Countries
Netherlands
Outcome results
None listed