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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01892904
First received: July 2, 2013
Last updated: July 23, 2014
Last verified: July 2014
  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.


Condition Intervention Phase
Dysmenorrhea
Drug: EE20/DRSP(BAY86-5300)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of days with dysmenorrheic pain over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ] [ Designated as safety issue: No ]
    Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary.


Secondary Outcome Measures:
  • Change in Dysmenorrhea score from baseline to period of withdrawal bleeding [ 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 ] [ Designated as safety issue: No ]
    Dysmenorrhea score is a sum of the two sub-scores, severity of dysmenorrhea and use of analgesics, recorded by the participant at every visit

  • Change of severity of pain Description [ 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 ] [ Designated as safety issue: No ]
    The severity of pain is measured by the Visual Analogue Scale (VAS), recorded by the participant at any visit.

  • Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ] [ Designated as safety issue: No ]
    Number of days with at least moderate dysmenorrheic pain is determined based on daily record of Patient Diary.

  • Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ] [ Designated as safety issue: No ]
    Number of days with rescue medicine is determined based on daily record of Patient Diary.

  • Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ] [ Designated as safety issue: No ]
    Number of days with interference of dysmenorrheic pain with daily activity is determined based on daily record of Patient Diary

  • Endometrial thickness [ Time Frame: 24 weeks after taking the initial study medication ] [ Designated as safety issue: No ]
    Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.

  • Number of days with bleeding and spotting over treatment phase [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Number of days with spotting/bleeding is determined based on daily record of Patient Diary.


Enrollment: 216
Study Start Date: July 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
Drug: EE20/DRSP(BAY86-5300)
One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day
Active Comparator: 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)
Drug: EE20/DRSP(BAY86-5300)
One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892904

Locations
Japan
Matsudo, Chiba, Japan, 270-2267
Hachioji, Tokyo, Japan, 192-0046
Minato, Tokyo, Japan, 108-0071
Setagaya-ku, Tokyo, Japan, 157-0066
Suginami-ku, Tokyo, Japan, 167-0051
Toshima-ku, Tokyo, Japan, 171-0021
Osaka, Japan, 542-0086
Osaka, Japan, 530-0013
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01892904     History of Changes
Other Study ID Numbers: 16114
Study First Received: July 2, 2013
Last Updated: July 23, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
YAZ
Flexible regimen
Drospirenone
Ethinylestradiol Betadex
Dysmenorrhea
Japanese patients

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Ethinyl Estradiol
Drospirenone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on July 24, 2014