Hormonal contraceptive method
Conditions
Interventions
Estetrol, in 3 different doses 5 mg E4, 10 mg E4 and 20 mg E4, each in combination with a progeston will be administered daily during three treatment cycles.
Sponsors
Estetra S.A.
mw. X.Y. Zimmerman
p/a Postbus 464
3700 AL Zeist
Tel: +31 30 6 985 020
Fax: +31 30 6 985 021
yz@pantarheibio.com
Eligibility
Inclusion criteria
Inclusion criteria: 1. At least 18 years and not older than 35 years of age; 2. Willing to use a barrier method of contraception during wash-out; 3. Women who ovulate in the pre-treatment cycle between day 9 and day 24; 4. Body mass index between 18 and 30 kg/m2; 5. Good physical and mental health as judged by the Investigator determined by medical and gynaecological history, physical examination, clinical laboratory and vital signs; 6. Both ovaries visible upon vaginal ultrasonography; 7. Willing to give informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. Clinically significant abnormal results of routine haematology, serum biocemistry, urinalysis and/or ECG; 2. Women with a washout cycle with a duration of more than 42 days; 3. Known or suspected pregnancy; 4. Lactation; 5. Pregnancy during accurate hormonal contraceptive use in the past; 6. Known or suspected breast cancer or a history of breast cancer; 7. Clinically significant abnormalities of the uterus and/or ovaries detected by examination and/or ultrasound; 8. A cervical smear with clinically relevant cytology with three years before study start; 9. Use of (hormonal) IUD within 2 months before screening; 10. Use of phytoestrogens; 11. Contraindications for contraceptive steroids; 12. Use of one or more of the following medications: A. Antihypertensive drugs; B. Present use or within 2 cycles before start study medication: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids and St. John¡¯s wort (Hypericum perforatum). 13. Status post-partum or post-abortion within a period of 2 months before study start; 14. Administration of investigational drugs within 2 months before screening; 15. A history of (within 12 months) alcohol and drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Follicle development will be measured in both ovaries by transvaginal ultrasound during the pre-treatment cycle, cycle 1 and cycle 3 on frequent timepoints during each cycle; 2. Liver parameters (carrier proteins, lipids, haemostasis, liver function, bone, glucose metabolism) will be measured at pre-treatment cycle, at the day 3 and 24 of cycle 1 and cycle 3, and at follow up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cervical smear; 2. Endometrial thickness; 3. Vaginal bleeding; 4. Endocrinology; 5. Safety. | — |
Contacts
Public ContactC. Klipping
Hanzeplein 1
Outcome results
None listed