Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EE20/DRSP(BAY86-5300)-flexibel extended regimen

One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day with flexible extended regimen (24-day to 120-day active tablet intake followed by 4-day tablet free interval)

Group Type EXPERIMENTAL

EE20/DRSP(BAY86-5300)

Intervention Type DRUG

One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day

EE20/DRSP(BAY86-5300)-28 days cyclic regimen

One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day with 28-day cyclic regimen (24-day active tablet intake followed by 4-day placebo tablet intake)

Group Type ACTIVE_COMPARATOR

EE20/DRSP(BAY86-5300)

Intervention Type DRUG

One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day

Interventions

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EE20/DRSP(BAY86-5300)

One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 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)

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No