Status:
COMPLETED
Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2
Lead Sponsor:
Estetra
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
This is an open-label, multi-centre, comparative study in young, healthy, female volunteers of reproductive age. Primary objective: \- To investigate the effect of 2 dosages of estetrol combined wit...
Eligibility Criteria
Inclusion
- Women willing to use a Combined Oral Contraceptive for 6 subsequent cycles
- Good physical and mental health
- Regular menstrual cycle (24-35 days) prior to screening
- Body mass index between (≥) 18 and (≤) 30 kg/m2
Exclusion
- Previous use of any hormonal contraceptive method during the last 3 months prior to randomisation (only applicable for women who are not using a hormonal contraceptive method at the time of screening)
- Previous use of progestogen-only contraceptive methods during the last 3 months or during the last 6 months for depot progestogen preparations or an injectable hormonal method of contraception
- Use of phytoestrogens
- No spontaneous menstruation has occurred following a delivery or abortion
- Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation
- Status post-partum or post-abortion within a period of 2 months before screening
- Pregnancy during accurate hormonal contraceptive use in the past
- Intention to become pregnant during the study
- An abnormal cervical smear within one year before study start
- Untreated Chlamydia infection
- Known or suspected breast cancer or a history of breast cancer
- A history of (within 12 months) alcohol or drug abuse
- Any clinically relevant abnormality
- Contraindications for the contraceptive steroids used in the clinical trial
- Use of antihypertensive drugs or use of medications interacting with the contraceptive steroids used in the clinical trial
- Administration of any other investigational drug within 2 months prior to screening
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT01221831
Start Date
September 1 2010
End Date
September 1 2011
Last Update
September 14 2012
Active Locations (10)
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1
Mehiläinen Helsinki
Helsinki, Finland
2
Väestöliitto Helsinki
Helsinki, Finland
3
YTHS Jyvaskyla
Jyväskylä, Finland
4
Laboratorio Simpanen
Kuopio, Finland