Clinical trial NCT01892904: Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysmenorrhea
Keywords: YAZ
Flexible regimen
Drospirenone
Ethinylestradiol Betadex
Dysmenorrhea
Japanese patients
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-07-08
Enrollment: 216
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of days with dysmenorrheic pain over 140 days of evaluation period
timeFrame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Secondary outcomes:
measure: Change in Dysmenorrhea score from baseline to period of withdrawal bleeding
timeFrame: 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
measure: Change of severity of pain Description
timeFrame: 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
measure: Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period
timeFrame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
measure: Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period
timeFrame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
measure: Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period
timeFrame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
measure: Endometrial thickness
timeFrame: 24 weeks after taking the initial study medication
measure: Number of days with bleeding and spotting over treatment phase
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Matsudo
country: Japan
state: Chiba
city: Hachioji
country: Japan
state: Tokyo
city: Minato
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Suginami-ku
country: Japan
state: Tokyo
city: Toshima-ku
country: Japan
state: Tokyo
city: Osaka
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Momoeda M, Akiyama S, Yamamoto S, Kondo M, Fukai T. Burden of Menstrual Pain Measured by Heatmap Visualization of Daily Patient-Reported Data in Japanese Patients Treated with Ethinylestradiol/Drospirenone: A Randomized Controlled Study. Int J Womens Health. 2020 Mar 10;12:175-185. doi: 10.2147/IJWH.S242864. eCollection 2020.