Dysmenorrhea Clinical Trial
Official title:
A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of a Flexible Extended Regimen of BAY 86-5300 (0.02 mg Ethinylestradiol [β-CDC] and 3 mg Drospirenone) Compared to the 28-day (24 + 4-day) Regimen of BAY 86-5300 in the Treatment of Dysmenorrhea for 24 Weeks
Verified date | September 2015 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 216 |
Est. completion date | August 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of days with dysmenorrheic pain over 140 days of evaluation period | Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary. | Evaluation period which starts on 25th day after start of treatment and lasts for 140 days | No |
Secondary | Change in Dysmenorrhea score from baseline to period of withdrawal bleeding | Dysmenorrhea score is a sum of the two sub-scores, severity of dysmenorrhea and use of analgesics, recorded by the participant at every visit | 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 | No |
Secondary | Change of severity of pain Description | The severity of pain is measured by the Visual Analogue Scale (VAS), recorded by the participant at any visit. | 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 | No |
Secondary | Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period | Number of days with at least moderate dysmenorrheic pain is determined based on daily record of Patient Diary. | Evaluation period which starts on 25th day after start of treatment and lasts for 140 days | No |
Secondary | Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period | Number of days with rescue medicine is determined based on daily record of Patient Diary. | Evaluation period which starts on 25th day after start of treatment and lasts for 140 days | No |
Secondary | Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period | Number of days with interference of dysmenorrheic pain with daily activity is determined based on daily record of Patient Diary | Evaluation period which starts on 25th day after start of treatment and lasts for 140 days | No |
Secondary | Endometrial thickness | Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography. | 24 weeks after taking the initial study medication | No |
Secondary | Number of days with bleeding and spotting over treatment phase | Number of days with spotting/bleeding is determined based on daily record of Patient Diary. | Up to 24 weeks | No |
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