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

NCT01892904 | Completed Phase 3

• 1 other identifier: 16114
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 8

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.

Conditions

Dysmenorrhea

Keywords

YAZ; Flexible regimen; Drospirenone; Ethinylestradiol Betadex; Dysmenorrhea; Japanese patients

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change in Dysmenorrhea score from baseline to period of withdrawal bleeding

  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

• Change of severity of pain Description

  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

• Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period

  Evaluation period which starts on 25th day after start of treatment and lasts for 140 days

• Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period

  Evaluation period which starts on 25th day after start of treatment and lasts for 140 days

• Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period

  Evaluation period which starts on 25th day after start of treatment and lasts for 140 days

Study Arms (2)

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

EXPERIMENTAL

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)

Drug: EE20/DRSP(BAY86-5300)

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

ACTIVE COMPARATOR

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)

Drug: EE20/DRSP(BAY86-5300)

Interventions

EE20/DRSP(BAY86-5300) DRUG

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

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

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (8)

Unknown Facility

Matsudo, Chiba, 270-2267, Japan

Location

Unknown Facility

Osaka, Osaka, 530-0013, Japan

Location

Unknown Facility

Osaka, Osaka, 542-0086, Japan

Location

Unknown Facility

Hachiōji, Tokyo, 192-0046, Japan

Location

Unknown Facility

Minato, Tokyo, 108-0071, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, 157-0066, Japan

Location

Unknown Facility

Suginami-ku, Tokyo, 167-0051, Japan

Location

Unknown Facility

Toshima-ku, Tokyo, 171-0021, Japan

Location

Related Publications (1)

• 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.

  PMID: 32210639 DERIVED

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 8, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

JP (8)