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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01697111
First received: September 28, 2012
Last updated: September 3, 2014
Last verified: September 2014

September 28, 2012
September 3, 2014
October 2012
March 2014   (final data collection date for primary outcome measure)
Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24) [ Time Frame: Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24) ] [ Designated as safety issue: No ]
The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)
Same as current
Complete list of historical versions of study NCT01697111 on ClinicalTrials.gov Archive Site
  • Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain) [ Time Frame: Weeks 17-24 of treatment period ] [ Designated as safety issue: No ]
    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) [ Time Frame: Weeks 17-24 of treatment period ] [ Designated as safety issue: No ]
    Pelvic pain is the worst pain on a 0-10 scale rated by the participant.
  • Dyspareunia [ Time Frame: Weeks 17-24 of treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 17-24 of treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks after taking the initial study medication ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks after taking the initial study medication ] [ Designated as safety issue: No ]
    Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.
  • Number of days with spotting/bleeding [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
    Number of days with spotting/bleeding is determined based on daily record of Patient Diary.
Same as current
Not Provided
Not Provided
 
Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Endometriosis
  • Drug: EE20/DRSP(BAY86-5300)
    One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day
  • 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
  • Drug: Dienogest
    Dienogest 1mg twice a day (bid)
  • Experimental: Arm 1
    Intervention: Drug: EE20/DRSP(BAY86-5300)
  • Experimental: Arm 2
    Intervention: Drug: Placebo
  • Active Comparator: Arm 3
    Intervention: Drug: Dienogest
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
312
December 2014
March 2014   (final data collection date for primary outcome measure)

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)
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01697111
15457
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP