Dysmenorrhea
Conditions
Keywords
YAZ, Flexible regimen, Drospirenone, Ethinylestradiol Betadex, Dysmenorrhea, Japanese patients
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 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.
Interventions
One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days with dysmenorrheic pain over 140 days of evaluation period | Evaluation period which starts on 25th day after start of treatment and lasts for 140 days | Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of severity of pain Description | Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days | The severity of pain is measured by the Visual Analogue Scale (VAS), recorded by the participant at any visit. |
| Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period | Evaluation period which starts on 25th day after start of treatment and lasts for 140 days | Number of days with at least moderate dysmenorrheic pain is determined based on daily record of Patient Diary. |
| Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period | Evaluation period which starts on 25th day after start of treatment and lasts for 140 days | Number of days with rescue medicine is determined based on daily record of Patient Diary. |
| Change in Dysmenorrhea score from baseline to period of withdrawal bleeding | Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days | Dysmenorrhea score is a sum of the two sub-scores, severity of dysmenorrhea and use of analgesics, recorded by the participant at every visit |
| Endometrial thickness | 24 weeks after taking the initial study medication | Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography. |
| Number of days with bleeding and spotting over treatment phase | Up to 24 weeks | Number of days with spotting/bleeding is determined based on daily record of Patient Diary. |
| Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period | Evaluation period which starts on 25th day after start of treatment and lasts for 140 days | Number of days with interference of dysmenorrheic pain with daily activity is determined based on daily record of Patient Diary |
Countries
Japan
Outcome results
None listed