Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
The is a multi-center, randomized, open-label, active-controlled, parallel-group comparative
 study (24-week treatment period).

 The objective of this study is to prove the superiority of BAY 86-5300 with flexible extended
 regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in terms of
 primary efficacy variable, number of days with dysmenorrheic pain over 140 days of evaluation
 period.

 In addition, the long-term safety of the flexible extended regimen of BAY86-5300 in patients
 treated for one year will be investigated.
Inclusion Criteria: - Dysmenorrhea patients with a total dysmenorrhea score (sum of the two
 sub-scores: severity of dysmenorrhea and use of analgesics) of at least 3 points in each of
 the last two menstruations before randomization (baseline observation phase)

 -  Patients with dysmenorrheic pain during the 2 baseline cycles before randomization.
 Dysmenorrheic pain means any spasmodic pelvic pain or lower abdominal pain with
 possible radiation towards back or thighs recorded in the Patient Diary in
 correspondence with a withdrawal and/or menstrual bleeding episode. Pain could start
 up to 2 days before the onset of the bleeding episode the bleeding and terminates on
 the last day of bleeding of before

 -  Patients having the regular cyclic menstrual period (25 to 38 days) in the latest two
 menses before randomization (baseline observation phase)

 -  Willingness to use a barrier method (i.e., non-hormonal method) for contraception
 during the study. Acceptable methods of contraception include (i) condoms (male or
 female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with
 spermicide; (iii) intra-uterine device.

 Exclusion Criteria: - Patients who have organic diseases of which surgical treatment is
 prioritized by the investigator

 -  Patients aged 40 years or older with ovarian chocolate cysts being more than 10 cm in
 size of the longest diameters

 -  Patients with ovarian chocolate cysts having solid part in the cyst

 -  Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese
 Labeling)