Endometriosis
Conditions
Keywords
YAZ, Flexible regimen, Drospirenone, Ethinylestradiol Betadex, Endometriosis, Dienogest, Japanese Patients
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.
Interventions
One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day
DRUGPlacebo
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
DRUGDienogest
Dienogest 1mg twice a day (bid)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Japan
Outcome results
None listed