Contraception
Conditions
Brief summary
The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Interventions
7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo
DRUGSH D 593 B (Miranova)
7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female volunteers aged between 18 and 50 years requiring contraception
Exclusion criteria
* Pregnancy or lactation * Any conditions that might interfere with the outcome as well as all contraindications for OC use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding pattern | 7 treatment cycles each consisting of 28 days |
| Number of unintended pregnancies | 7 treatment cycles each consisting of 28 days and follow-up period of 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event collection | 7 treatment cycles each consisting of 28 days and follow-up period of 14 days |
Countries
Czechia, France, Germany
Outcome results
None listed