Study Completed

Dysmenorrhea

Bayer Identifier:

16114

ClinicalTrials.gov Identifier:

NCT01892904

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Female

Age

20 - N/A

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

July 2013 - August 2015

Phase

Phase 3

Could I Receive a placebo

Products

EE20/DRSP (BAY86-5300)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Suginami-ku, 167-0051, Japan
Completed		Toshima-ku, 171-0021, Japan
Completed		Setagaya-ku, 157-0066, Japan
Completed		Osaka, 542-0086, Japan
Completed		Hachioji, 192-0046, Japan
Completed		Minato, 108-0071, Japan
Completed		Matsudo, 270-2267, Japan
Completed		Osaka, 530-0013, Japan

Primary Outcome

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.
Time Frame:
Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Safety Issue:
No

Secondary Outcome

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
Time Frame:
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
Safety Issue:
No
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.
Time Frame:
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
Safety Issue:
No
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.
Time Frame:
Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Safety Issue:
No
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.
Time Frame:
Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Safety Issue:
No
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
Time Frame:
Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Safety Issue:
No
Endometrial thickness
Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.
Time Frame:
24 weeks after taking the initial study medication
Safety Issue:
No
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.
Time Frame:
Up to 24 weeks
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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