check_circleStudy Completed

Endometriosis

Bayer Identifier:

15457

ClinicalTrials.gov Identifier:

NCT01697111

EudraCT Number:

Not Available

EU CT Number:

Not Available
Comparative study of BAY86-5300 with an extended flexible regimen for endometriosis

Trial 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.

Key Participants Requirements

Sex

Female

Age

20 - N/A
  • - 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
  • - 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)

Trial summary

Enrollment Goal
312
Trial Dates
October 2012 - December 2014
Phase
Phase 3
Could I Receive a placebo
Yes
Products
EE20/DRSP (BAY86-5300)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Yazaki ClinicTakasaki, 370-0883, Japan
Completed
Kitasato University Medeical CenterKitamoto, 364-8501, Japan
Completed
Kusunoki ClinicItabashi, 175-0092, Japan
Terminated
Women's Wellness Ginza ClinicChuo-ku, 104-0061, Japan
Completed
Yukawa Women's ClinicNishitokyo, 188-0011, Japan
Completed
Machida Higashiguchi ClinicMachida, 194-0022, Japan
Completed
Akasakamitsuke Miyazaki Obstetrics & Gynecology ClinicMinato, 107-0051, Japan
Completed
NS ClinicHachioji, 192-0046, Japan
Completed
Shonan Kamakura General HospitalKamakura, 247-8533, Japan
Completed
Medical Corporation Eikoukai Yakou Lady's ClinicYokohama, 230-0001, Japan
Completed
Meitetsu HospitalNagoya, 451-8511, Japan
Completed
Daiyukai Daiichi HospitalIchinomiya, 491-8551, Japan
Completed
Yachiyo HospitalAnjo, 446-8510, Japan
Completed
Sakie Ladies ClinicNagoya, 464-0066, Japan
Completed
Kano's Clinic for WomenNagoya, 460-0011, Japan
Completed
Gifu Prefectural General Medical CenterGifu, 500-8717, Japan
Completed
Ishikawa Prefectural Central HospitalKanazawa, 920-8530, Japan
Completed
Fukui Prefectural HospitalFukui, 910-8526, Japan
Completed
Katou Internal medicine and Gynecology ClinicFukui, 910-0845, Japan
Completed
Yoshimura Ladies ClinicToyonaka, 560-0022, Japan
Completed
Osaka Central HospitalOsaka, 530-0001, Japan
Completed
The Veritas HospitalKawanishi, 666-0125, Japan
Completed
Shinsuma HospitalKobe, 654-0047, Japan
Completed
Kawasaki Saiwai ClinicKawasaki, 212-0016, Japan
Completed
Itami City HospitalItami, 664-8540, Japan
Completed
Sei Womens ClinicBunkyo, 112-0014, Japan
Completed
Akazawa ClinicFuchu, 183-0056, Japan
Completed
Toranomon Womens ClinicMinato, 105-0001, Japan
Completed
Juno Vesta Clinic HattaMatsudo, 270-2267, Japan
Completed
Motomachi Ladies ClinicYokohama, 231-0023, Japan
Completed
Hayakawa ClinicOsaka, 542-0086, Japan
Completed
Chayamachi Ladies ClinicOsaka, 530-0013, Japan
Completed
Women's Wellness Tsushima Ruriko Josei Life ClinicChuo-ku, 104-0061, Japan

Primary Outcome

  • Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24)
    The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)
    date_rangeTime Frame:
    Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain)
    Pelvic pain is the worst pain on a 0-10 scale rated by the participant.
    date_rangeTime Frame:
    Weeks 17-24 of treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain)
    Pelvic pain is the worst pain on a 0-10 scale rated by the participant.
    date_rangeTime Frame:
    Weeks 17-24 of treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Dyspareunia
    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.
    date_rangeTime Frame:
    Weeks 17-24 of treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Average of pain
    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.
    date_rangeTime Frame:
    Weeks 17-24 of treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Size of chocolate cyst
    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.
    date_rangeTime Frame:
    24 weeks after taking the initial study medication
    enhanced_encryption
    Safety Issue:
    No
  • Endometrial thickness
    Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.
    date_rangeTime Frame:
    24 weeks after taking the initial study medication
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with spotting/bleeding
    Number of days with spotting/bleeding is determined based on daily record of Patient Diary.
    date_rangeTime Frame:
    Up to 52 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

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