Trial Condition(s):

Dysmenorrhea

Comparative study of BAY86-5300 with a flexible extended regimen for dysmenorrhea

Bayer Identifier:

16114

ClinicalTrials.gov Identifier:

NCT01892904

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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)

Trial Summary

Enrollment Goal
216
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
EE20/DRSP (BAY86-5300)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Suginami-ku, Japan, 167-0051

Status
Completed
 
Locations

Investigative Site

Toshima-ku, Japan, 171-0021

Status
Completed
 
Locations

Investigative Site

Setagaya-ku, Japan, 157-0066

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 542-0086

Status
Completed
 
Locations

Investigative Site

Hachioji, Japan, 192-0046

Status
Completed
 
Locations

Investigative Site

Minato, Japan, 108-0071

Status
Completed
 
Locations

Investigative Site

Matsudo, Japan, 270-2267

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 530-0013

Status
Completed
 

Trial Design