Pilot study: Non-interventional study to observe and document the use of KadeZyklus(R) bei Krämpfen während der Menstruation in gynaecological practice with regard to the perceived change in cramps during menstruation and tolerability of the treatment.
- Conditions
- N94.4Primary dysmenorrhoea
- Registration Number
- DRKS00030658
- Lead Sponsor
- DR. KADE Pharmazeutische Fabrik GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 25
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.
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in pain level of the cramps in cycle 1, 2 compared to before the start of the intake.
- Secondary Outcome Measures
Name Time Method - Change in effect of cramps on daily life in cycle 1, 2 compared to before start of intake<br>- Change in impairment of quality of life after cycle 2 compared to before the start of treatment<br>- Assessment of tolerability and efficacy (doctor and patient)<br>- Evaluation of the patient's expectations of the preparation<br>- Frequency of use of the preparation <br>- Additional medication to KadeZyklus for cramps during menstruation <br>- Patient's intention to continue taking the product<br>- Likelihood of recommendation<br><br>Safety parameters<br>Frequency and type of adverse drug reactions