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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01697111

Collaborator

(none)

312

Enrollment

Locations

Arms

Duration (Months)

9.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

312 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24) [Baseline period (8 weeks before start of treatment) and 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) [Weeks 17-24 of treatment period]
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) [Weeks 17-24 of treatment period]
Pelvic pain is the worst pain on a 0-10 scale rated by the participant.
Dyspareunia [Weeks 17-24 of treatment period]
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 [Weeks 17-24 of treatment period]
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 [24 weeks after taking the initial study medication]
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 [24 weeks after taking the initial study medication]
Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.
Number of days with spotting/bleeding [Up to 52 weeks]
Number of days with spotting/bleeding is determined based on daily record of Patient Diary.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts 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)

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Anjo	Aichi	Japan	446-8510
2	Ichinomiya	Aichi	Japan	491-8551
3	Nagoya	Aichi	Japan	451-8511
4	Nagoya	Aichi	Japan	460-0011
5	Nagoya	Aichi	Japan	464-0066
6	Matsudo	Chiba	Japan	270-2267
7	Takasaki	Gunma	Japan	370-0883
8	Itami	Hyogo	Japan	664-8540
9	Kawanishi	Hyogo	Japan	666-0125
10	Kobe	Hyogo	Japan	654-0047
11	Kanazawa	Ishikawa	Japan	920-8530
12	Kamakura	Kanagawa	Japan	247-8533
13	Kawasaki	Kanagawa	Japan	212-0016
14	Yokohama	Kanagawa	Japan	230-0001
15	Yokohama	Kanagawa	Japan	231-0023
16	Toyonaka	Osaka	Japan	560-0022
17	Kitamoto	Saitama	Japan	364-8501
18	Bunkyo	Tokyo	Japan	112-0014
19	Chuo-ku	Tokyo	Japan	104-0061
20	Fuchu	Tokyo	Japan	183-0056
21	Hachioji	Tokyo	Japan	192-0046
22	Itabashi	Tokyo	Japan	175-0092
23	Machida	Tokyo	Japan	194-0022
24	Minato	Tokyo	Japan	105-0001
25	Minato	Tokyo	Japan	107-0051
26	Nishitokyo	Tokyo	Japan	188-0011
27	Fukui		Japan	910-0845
28	Fukui		Japan	910-8526
29	Gifu		Japan	500-8717
30	Osaka		Japan	530-0001
31	Osaka		Japan	530-0013
32	Osaka		Japan	542-0086