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

Primary Purpose

Endometriosis

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

EE20/DRSP(BAY86-5300)

Placebo

Dienogest

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring YAZ, Flexible regimen, Drospirenone, Ethinylestradiol Betadex, Endometriosis, Dienogest, Japanese Patients

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

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.

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.

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.

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.

Endometrial thickness

Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.

Number of days with spotting/bleeding

Number of days with spotting/bleeding is determined based on daily record of Patient Diary.

Full Information

NCT ID

NCT01697111

First Posted

September 28, 2012

Last Updated

February 16, 2016

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01697111

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

Keywords

YAZ, Flexible regimen, Drospirenone, Ethinylestradiol Betadex, Endometriosis, Dienogest, Japanese Patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

312 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Arm Title

Arm 3

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

EE20/DRSP(BAY86-5300)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dienogest

Intervention Description

Dienogest 1mg twice a day (bid)

Primary Outcome Measure Information:

Title

Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24)

Description

The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)

Time Frame

Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)

Secondary Outcome Measure Information:

Title

Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain)

Description

Pelvic pain is the worst pain on a 0-10 scale rated by the participant.

Time Frame

Weeks 17-24 of treatment period

Title

Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain)

Description

Pelvic pain is the worst pain on a 0-10 scale rated by the participant.

Time Frame

Weeks 17-24 of treatment period

Title

Dyspareunia

Description

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.

Time Frame

Weeks 17-24 of treatment period

Title

Average of pain

Description

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.

Time Frame

Weeks 17-24 of treatment period

Title

Size of chocolate cyst

Description

Time Frame

24 weeks after taking the initial study medication

Title

Endometrial thickness

Description

Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.

Time Frame

24 weeks after taking the initial study medication

Title

Number of days with spotting/bleeding

Description

Number of days with spotting/bleeding is determined based on daily record of Patient Diary.

Time Frame

Up to 52 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Anjo

State/Province

Aichi

ZIP/Postal Code

446-8510

Country

Japan

City

Ichinomiya

State/Province

Aichi

ZIP/Postal Code

491-8551

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

451-8511

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

460-0011

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

464-0066

Country

Japan

City

Matsudo

State/Province

Chiba

ZIP/Postal Code

270-2267

Country

Japan

City

Takasaki

State/Province

Gunma

ZIP/Postal Code

370-0883

Country

Japan

City

Itami

State/Province

Hyogo

ZIP/Postal Code

664-8540

Country

Japan

City

Kawanishi

State/Province

Hyogo

ZIP/Postal Code

666-0125

Country

Japan

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

654-0047

Country

Japan

City

Kanazawa

State/Province

Ishikawa

ZIP/Postal Code

920-8530

Country

Japan

City

Kamakura

State/Province

Kanagawa

ZIP/Postal Code

247-8533

Country

Japan

City

Kawasaki

State/Province

Kanagawa

ZIP/Postal Code

212-0016

Country

Japan

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

230-0001

Country

Japan

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

231-0023

Country

Japan

City

Toyonaka

State/Province

Osaka

ZIP/Postal Code

560-0022

Country

Japan

City

Kitamoto

State/Province

Saitama

ZIP/Postal Code

364-8501

Country

Japan

City

Bunkyo

State/Province

Tokyo

ZIP/Postal Code

112-0014

Country

Japan

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0061

Country

Japan

City

Fuchu

State/Province

Tokyo

ZIP/Postal Code

183-0056

Country

Japan

City

Hachioji

State/Province

Tokyo

ZIP/Postal Code

192-0046

Country

Japan

City

Itabashi

State/Province

Tokyo

ZIP/Postal Code

175-0092

Country

Japan

City

Machida

State/Province

Tokyo

ZIP/Postal Code

194-0022

Country

Japan

City

Minato

State/Province

Tokyo

ZIP/Postal Code

105-0001

Country

Japan

City

Minato

State/Province

Tokyo

ZIP/Postal Code

107-0051

Country

Japan

City

Nishitokyo

State/Province

Tokyo

ZIP/Postal Code

188-0011

Country

Japan

City

Fukui

ZIP/Postal Code

910-0845

Country

Japan

City

Fukui

ZIP/Postal Code

910-8526

Country

Japan

City

Gifu

ZIP/Postal Code

500-8717

Country

Japan

City

Osaka

ZIP/Postal Code

530-0001

Country

Japan

City

Osaka

ZIP/Postal Code

530-0013

Country

Japan

City

Osaka

ZIP/Postal Code

542-0086

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

28911925

Citation

Harada T, Kosaka S, Elliesen J, Yasuda M, Ito M, Momoeda M. Ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen for the management of endometriosis-associated pelvic pain: a randomized controlled trial. Fertil Steril. 2017 Nov;108(5):798-805. doi: 10.1016/j.fertnstert.2017.07.1165. Epub 2017 Sep 11.

Results Reference

derived

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

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