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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01892904
Other study ID # 16114
Secondary ID
Status Completed
Phase Phase 3
First received July 2, 2013
Last updated September 8, 2015
Start date July 2013
Est. completion date August 2015

Study information

Verified date September 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
EE20/DRSP(BAY86-5300)
One tablet [0.02 mg of ethinylestradiol (ß-CDC) and 3 mg of drospirenone] / day

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

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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