The study aims to evaluate the bleeding pattern, side-effects, cardiovascular riskmarker, sexual function and user-satisfaction when combined contraceptive hormonal methods are being administered continuously without hormonfree intervals. The products to be studied are since long marketed and frequently used and studied during cyclic use MedDRA version: 9.1 Level: LLT Classification code 10010808 Term: Contraception
Conditions
Interventions
Trade Name: Yasmin
Pharmaceutical Form: Tablet
INN or Proposed INN: DROSPIRENONE
CAS Number: 67392874
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
INN or Pro
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy fertile women between 18 and 45 years of age. Desire for a hormonal contraceptive method. Willing to participate in the study for 12 months 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: Any contraindication for estrogen containing treatment. Regular medication with non-steroid anti-inflammatory drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare cardiovascular riskmarkers and side-effects between combined contraceptive hormonal methods administered cyclic (i.e 3 weeks followed by 7 days hormon-free interval) and continuous for 6 months;Secondary Objective: To compare sexual function and well-being between subjects using cyclic and continuous contraceptive methods;Primary end point(s): Are there any differences in the cardiovascular factors if estrogen and gestagen are administered during longer periods without hormon-free intervals? Could this mode of administration benefit users? How will the bleeding pattern change? | — |
Countries
Sweden
Outcome results
None listed