Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis
This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01697111
First received: September 28, 2012
Last updated: May 30, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Endometriosis |
Drug: EE20/DRSP(BAY86-5300) Drug: Placebo Drug: Dienogest |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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)
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697111
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Locations
| Japan | |
| Recruiting | |
| Anjo, Aichi, Japan, 446-8510 | |
| Recruiting | |
| Ichinomiya, Aichi, Japan, 491-8551 | |
| Recruiting | |
| Nagoya, Aichi, Japan, 451-8511 | |
| Recruiting | |
| Nagoya, Aichi, Japan, 464-0066 | |
| Recruiting | |
| Nagoya, Aichi, Japan, 460-0011 | |
| Recruiting | |
| Matsudo, Chiba, Japan, 270-2267 | |
| Recruiting | |
| Takasaki, Gunma, Japan, 370-0883 | |
| Recruiting | |
| Itami, Hyogo, Japan, 664-8540 | |
| Recruiting | |
| Kawanishi, Hyogo, Japan, 666-0125 | |
| Recruiting | |
| Kobe, Hyogo, Japan, 654-0047 | |
| Recruiting | |
| Kanazawa, Ishikawa, Japan, 920-8530 | |
| Recruiting | |
| Kamakura, Kanagawa, Japan, 247-8533 | |
| Recruiting | |
| Kawasaki, Kanagawa, Japan, 212-0016 | |
| Recruiting | |
| Yokohama, Kanagawa, Japan, 230-0001 | |
| Recruiting | |
| Yokohama, Kanagawa, Japan, 231-0023 | |
| Recruiting | |
| Toyonaka, Osaka, Japan, 560-0022 | |
| Recruiting | |
| Kitamoto, Saitama, Japan, 364-8501 | |
| Recruiting | |
| Bunkyo, Tokyo, Japan, 112-0014 | |
| Recruiting | |
| Chuo-ku, Tokyo, Japan, 104-0061 | |
| Terminated | |
| Chuo-ku, Tokyo, Japan, 104-0061 | |
| Recruiting | |
| Fuchu, Tokyo, Japan, 183-0056 | |
| Recruiting | |
| Hachioji, Tokyo, Japan, 192-0046 | |
| Recruiting | |
| Itabashi, Tokyo, Japan, 175-0092 | |
| Recruiting | |
| Machida, Tokyo, Japan, 194-0022 | |
| Recruiting | |
| Minato, Tokyo, Japan, 107-0051 | |
| Recruiting | |
| Minato, Tokyo, Japan, 105-0001 | |
| Recruiting | |
| Nishitokyo, Tokyo, Japan, 188-0011 | |
| Recruiting | |
| Fukui, Japan, 910-8526 | |
| Recruiting | |
| Fukui, Japan, 910-0845 | |
| Recruiting | |
| Gifu, Japan, 500-8717 | |
| Recruiting | |
| Osaka, Japan, 530-0013 | |
| Recruiting | |
| Osaka, Japan, 542-0086 | |
| Recruiting | |
| Osaka, Japan, 530-0001 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Head Medical Development Japan, Bayer Yakuhin, Ltd. |
| ClinicalTrials.gov Identifier: | NCT01697111 History of Changes |
| Other Study ID Numbers: | 15457 |
| Study First Received: | September 28, 2012 |
| Last Updated: | May 30, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Bayer:
|
YAZ Flexible regimen Drospirenone Ethinylestradiol Betadex |
Endometriosis Dienogest Japanese Patients |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female Ethinyl Estradiol Drospirenone Dienogest Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
Aldosterone Antagonists Hormone Antagonists Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents, Male |
ClinicalTrials.gov processed this record on June 18, 2013