The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as betadex clathrate \[β-CDC\]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a placebo-controlled comparative study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
0.02 mg EE (β-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle
Matching placebo tablets for 28 days per 28-day intake cycle
Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6
The patient marks the individual pain impression on a visual analogue scale in the range 0 (no pain) to 100mm (worst pain ever experienced)
Time frame: Baseline to week 17
Number of participants with adverse events as measure of safety and tolerability
Time frame: Up to 16 weeks
Number of days with dysmenorrhea
The occurrence of dysmenorrhea will be recorded in the patient diary
Time frame: Up to 16 weeks
Change in dysmenorrhea score
It is the sum of two four-stage sub-scales which assess the extent to which dysmenorrhea interferes with daily life \& the extent to which pain medication is used.
Time frame: Baseline to week 16
Changes from baseline to each menstrual period of total number of taken supportive analgesic medication
Standard Analgesic tablets are provided to participants
Time frame: Baseline to week 16
Changes from baseline to each menstrual period of days without supportive analgesic medication.
Time frame: Baseline to week 16
Clinical Global Impression(CGI)
The CGI is the measure of global improvement index from the opinion of the investigator and subject to document changes in the health status during treatment
Time frame: At week 16
Self administered SF-36 questionnaire
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The 36-items Short Form Health Survey (SF-36) (version 2.0) is a set of generic, coherent,and easily administered quality-of-life measures.
Time frame: At baseline and week 17
Changes from baseline to each menstrual period of severity of lumbago
The patient classifies the severity on a mild, moderate, severe scale
Time frame: Up to 16 weeks
Changes from baseline to each menstrual period of severity of headache
The patient classifies the severity on a mild, moderate, severe scale
Time frame: Up to 16 weeks
Changes from baseline to each menstrual period of severity of nausea/vomiting
The patient classifies the severity on a mild, moderate, severe scale
Time frame: Up to 16 weeks