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

Bayer312 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

312

Conditions

Endometriosis

Interventions

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

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)

Locations (32)

Unnamed facility

Anjo, Aichi-ken, Japan

Unnamed facility

Ichinomiya, Aichi-ken, Japan

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Matsudo, Chiba, Japan

Unnamed facility

Fukui-shi, Fukui, Japan

Unnamed facility

Fukui-shi, Fukui, Japan

Unnamed facility

Gifu, Gifu, Japan

Unnamed facility

Takasaki, Gunma, Japan

...and 22 more locations

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

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.

Time frame: Weeks 17-24 of treatment period

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.

Time frame: Weeks 17-24 of treatment period

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.

Time frame: Weeks 17-24 of treatment period

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.

Time frame: Weeks 17-24 of treatment period

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.

Time frame: 24 weeks after taking the initial study medication

Endometrial thickness

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

Time frame: 24 weeks after taking the initial study medication

Number of days with spotting/bleeding

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

Time frame: Up to 52 weeks