Status:
COMPLETED
Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
Lead Sponsor:
Bayer
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
20+ years
Phase:
PHASE3
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT01892904
Start Date
July 1 2013
End Date
August 1 2015
Last Update
September 9 2015
Active Locations (8)
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1
Matsudo, Chiba, Japan, 270-2267
2
Osaka, Osaka, Japan, 530-0013
3
Osaka, Osaka, Japan, 542-0086
4
Hachiōji, Tokyo, Japan, 192-0046