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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697111
• Other study ID #: 15457
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2012
• Last updated: February 16, 2016
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• EE20/DRSP(BAY86-5300)
One tablet [0.02 mg of ethinylestradiol (ß-CDC) and 3 mg of drospirenone] / day
• Placebo
One tablet (no active ingredient) / day and one tablet [0.02 mg of ethinylestradiol (ß-CDC) and 3 mg of drospirenone] / day, for the first 24 weeks and the later 28 weeks, respectively
• Dienogest
Dienogest 1mg twice a day (bid)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)	No
Secondary	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.	Weeks 17-24 of treatment period	No
Secondary	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.	Weeks 17-24 of treatment period	No
Secondary	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.	Weeks 17-24 of treatment period	No
Secondary	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.	Weeks 17-24 of treatment period	No
Secondary	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.	24 weeks after taking the initial study medication	No
Secondary	Endometrial thickness	Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.	24 weeks after taking the initial study medication	No
Secondary	Number of days with spotting/bleeding	Number of days with spotting/bleeding is determined based on daily record of Patient Diary.	Up to 52 weeks	Yes

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