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

Bayer

Status and phase: Completed; Phase 3

Conditions: Dysmenorrhea

Treatments: Drug: EE20/DRSP(BAY86-5300)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01892904

16114

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

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

Experimental group

Description:

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)

Treatment:

Drug: EE20/DRSP(BAY86-5300)

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

Active Comparator group

Description:

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)

Treatment:

Drug: EE20/DRSP(BAY86-5300)