Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01697111
First received: September 28, 2012
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study (24-week treatment-comparison phase) with an open-label reference arm of active comparator (dienogest) followed by 28-week long-term treatment phase.

The primary objective of this study is to confirm the superiority of BAY86-5300 when administered with an extended flexible regimen for the treatment of endometriosis-associated pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.

The secondary objective is to investigate the long-term safety of BAY86-5300 in patients treated with an extended flexible regimen for one year, and the bleeding pattern of BAY86-5300 when administered with an extended flexible regimen compared to dienogest.


Condition Intervention Phase
Endometriosis
Drug: EE20/DRSP(BAY86-5300)
Drug: Placebo
Drug: Dienogest
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blinded, Placebo-controlled, and Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of an Extended Flexible Regimen of BAY 86-5300 [0.02 mg Ethinylestradiol (β-CDC) and 3 mg Drospirenone] in the Patients With Endometriosis

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24) [ Time Frame: Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24) ] [ Designated as safety issue: No ]
    The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)


Secondary Outcome Measures:
  • Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain) [ Time Frame: Weeks 17-24 of treatment period ] [ Designated as safety issue: No ]
    Pelvic pain is the worst pain on a 0-10 scale rated by the participant.

  • Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain) [ Time Frame: Weeks 17-24 of treatment period ] [ Designated as safety issue: No ]
    Pelvic pain is the worst pain on a 0-10 scale rated by the participant.

  • Dyspareunia [ Time Frame: Weeks 17-24 of treatment period ] [ Designated as safety issue: No ]
    In case having sexual intercourse, dyspareunia pain is the worst pain on a 0-10 scale rated by the participant in the last 24 hours.

  • Average of pain [ Time Frame: Weeks 17-24 of treatment period ] [ Designated as safety issue: No ]
    The average of pain is the mean value of the Visual Analogue Scale (VAS) value during the time frame calculated for each patient based on daily record of Patient Diary.

  • Size of chocolate cyst [ Time Frame: 24 weeks after taking the initial study medication ] [ Designated as safety issue: No ]
    In case chocolate cyst is detected, size of chocolate cyst is a mean length (mm) of the longest axis and the short axis (crossing) of the largest chocolate cyst determined by transvaginal ultrasonography.

  • 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 spotting/bleeding [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
    Number of days with spotting/bleeding is determined based on daily record of Patient Diary.


Enrollment: 312
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: EE20/DRSP(BAY86-5300)
One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day
Experimental: Arm 2 Drug: Placebo
One tablet (no active ingredient) / day and one tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day, for the first 24 weeks and the later 28 weeks, respectively
Active Comparator: Arm 3 Drug: Dienogest
Dienogest 1mg twice a day (bid)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed as having endometriosis by laparotomy or laparoscopy, or by identification of chocolate cyst of endometriosis, or patients with the clinical diagnosis of endometriosis, who fulfill the condition of pelvic tenderness or induration of Cul-de-sac or uterine immobility
  • Patient with pelvic pain judged by the highest Visual Analogue Scale (VAS) value of 40 mm or higher which is determined during 2 menstrual cycles before randomization (baseline observation phase)
  • Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
  • Patients who do not wish to become pregnant during the course of the study

Exclusion Criteria:

  • Patients who have organic diseases of which surgical treatment is prioritized by investigator
  • Patients in whom any hormonal therapies, including combined oral contraceptives (COCs) and progestins, have failed for treatment of symptomatic endometriosis (moderate, severe pain)
  • Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)
  • Patients for whom dienogest is contraindicated (according to Japanese labeling of Dinagest Tab 1mg)
  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: NCT01697111

Locations
Japan
Anjo, Aichi, Japan, 446-8510
Ichinomiya, Aichi, Japan, 491-8551
Nagoya, Aichi, Japan, 451-8511
Nagoya, Aichi, Japan, 464-0066
Nagoya, Aichi, Japan, 460-0011
Matsudo, Chiba, Japan, 270-2267
Takasaki, Gunma, Japan, 370-0883
Itami, Hyogo, Japan, 664-8540
Kawanishi, Hyogo, Japan, 666-0125
Kobe, Hyogo, Japan, 654-0047
Kanazawa, Ishikawa, Japan, 920-8530
Kamakura, Kanagawa, Japan, 247-8533
Kawasaki, Kanagawa, Japan, 212-0016
Yokohama, Kanagawa, Japan, 231-0023
Yokohama, Kanagawa, Japan, 230-0001
Toyonaka, Osaka, Japan, 560-0022
Kitamoto, Saitama, Japan, 364-8501
Bunkyo, Tokyo, Japan, 112-0014
Chuo-ku, Tokyo, Japan, 104-0061
Fuchu, Tokyo, Japan, 183-0056
Hachioji, Tokyo, Japan, 192-0046
Itabashi, Tokyo, Japan, 175-0092
Machida, Tokyo, Japan, 194-0022
Minato, Tokyo, Japan, 107-0051
Minato, Tokyo, Japan, 105-0001
Nishitokyo, Tokyo, Japan, 188-0011
Fukui, Japan, 910-0845
Fukui, Japan, 910-8526
Gifu, Japan, 500-8717
Osaka, Japan, 530-0013
Osaka, Japan, 542-0086
Osaka, Japan, 530-0001
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01697111     History of Changes
Other Study ID Numbers: 15457
Study First Received: September 28, 2012
Last Updated: September 3, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
YAZ
Flexible regimen
Drospirenone
Ethinylestradiol Betadex
Endometriosis
Dienogest
Japanese Patients

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Drospirenone
Dienogest
Ethinyl Estradiol
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses
Estrogens
Hormones
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral
Contraceptive Agents, Female
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014