N94.4
Conditions
Interventions
Group 1: Treatment with KadeZyklus for cramps during menstruation
No intervention is planned as part of this observational study. The recommendation for the use of KadeZyklus bei Krämpfen während der
expectations of KadeZyklus bei Krämpfen
intention to continue taking the medicinal product in the future if symptoms recur
probability of recommendation.
In addition, adverse drug reactions are recorded.
Sponsors
DR. KADE Pharmazeutische Fabrik GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The patient has been informed about the study and has signed the informed consent form. The patient is at least 18 years old. Female gender (from birth). The patient suffers from primary dysmenorrhoea without organic causes with mild cramps during menstruation. The decision to use KadeZyklus bei Krämpfen was made independently and prior to inclusion in this NIS. The patient is currently planning to use KadeZyklus bei Krämpfen during her next two cycles according to the professional information / instructions for use. The patient agrees to keep the diary for the next two cycles and to hand it over or return it to the doctor. The patient suffered from mild cramps on at least 2 days in each of the last 3 cycles.
Exclusion criteria
Exclusion criteria: The patient has had irregular menstrual cycles for the last 3 months. The patient suffers from secondary dysmenorrhoea (painful menstruation of organic origin, endometriosis, fibroids, inflammatory changes). The patient has a known hypersensitivity to the active substance in KadeZyklus bei Krämpfen während der Menstruation, to other compositae or to any of the other ingredients listed in the product information. The patient is pregnant or breastfeeding The patient is participating in a parallel clinical trial during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain level of the cramps in cycle 1, 2 compared to before the start of the intake. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in effect of cramps on daily life in cycle 1, 2 compared to before start of intake - Change in impairment of quality of life after cycle 2 compared to before the start of treatment - Assessment of tolerability and efficacy (doctor and patient) - Evaluation of the patient's expectations of the preparation - Frequency of use of the preparation - Additional medication to KadeZyklus for cramps during menstruation - Patient's intention to continue taking the product - Likelihood of recommendation Safety parameters Frequency and type of adverse drug reactions | — |
Countries
Germany
Contacts
Public ContactRuth Diebold
DR. KADE Pharmazeutische Fabrik
Outcome results
None listed