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

• ClinicalTrials.gov Identifier: NCT01697111
• Recruitment Status: Completed
• First Posted: October 2, 2012
• Last Update Posted: February 18, 2016
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Endometriosis	Drug: EE20/DRSP(BAY86-5300); Drug: Placebo; Drug: Dienogest	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 312 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: October 2012
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. 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) ]
   The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)

Secondary Outcome Measures :

1. Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain) [ Time Frame: Weeks 17-24 of treatment period ]
   Pelvic pain is the worst pain on a 0-10 scale rated by the participant.
2. 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 ]
   Pelvic pain is the worst pain on a 0-10 scale rated by the participant.
3. Dyspareunia [ Time Frame: 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.
4. Average of pain [ Time Frame: 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.
5. Size of chocolate cyst [ Time Frame: 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.
6. Endometrial thickness [ Time Frame: 24 weeks after taking the initial study medication ]
   Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.
7. Number of days with spotting/bleeding [ Time Frame: Up to 52 weeks ]
   Number of days with spotting/bleeding is determined based on daily record of Patient Diary.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes 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

Locations

Japan

Anjo, Aichi, Japan, 446-8510

Ichinomiya, Aichi, Japan, 491-8551

Nagoya, Aichi, Japan, 451-8511

Nagoya, Aichi, Japan, 460-0011

Nagoya, Aichi, Japan, 464-0066

Matsudo, Chiba, Japan, 270-2267

Takasaki, Gunma, Japan, 370-0883

Itami, Hyogo, Japan, 664-8540

Kawanishi, Hyogo, Japan, 666-0125

Kobe, Hyogo, Japan, 654-0047

Kanazawa, Ishikawa, Japan, 920-8530

Kamakura, Kanagawa, Japan, 247-8533

Kawasaki, Kanagawa, Japan, 212-0016

Yokohama, Kanagawa, Japan, 230-0001

Yokohama, Kanagawa, Japan, 231-0023

Toyonaka, Osaka, Japan, 560-0022

Kitamoto, Saitama, Japan, 364-8501

Bunkyo, Tokyo, Japan, 112-0014

Chuo-ku, Tokyo, Japan, 104-0061

Fuchu, Tokyo, Japan, 183-0056

Hachioji, Tokyo, Japan, 192-0046

Itabashi, Tokyo, Japan, 175-0092

Machida, Tokyo, Japan, 194-0022

Minato, Tokyo, Japan, 105-0001

Minato, Tokyo, Japan, 107-0051

Nishitokyo, Tokyo, Japan, 188-0011

Fukui, Japan, 910-0845

Fukui, Japan, 910-8526

Gifu, Japan, 500-8717

Osaka, Japan, 530-0001

Osaka, Japan, 530-0013

Osaka, Japan, 542-0086

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Additional Information:

Click here and search for websynopsis results posting. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Harada T, Kosaka S, Elliesen J, Yasuda M, Ito M, Momoeda M. Ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen for the management of endometriosis-associated pelvic pain: a randomized controlled trial. Fertil Steril. 2017 Nov;108(5):798-805. doi: 10.1016/j.fertnstert.2017.07.1165. Epub 2017 Sep 11.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01697111
• Other Study ID Numbers: 15457
• First Posted: October 2, 2012
• Last Update Posted: February 18, 2016
• Last Verified: January 2016

Keywords provided by Bayer:

YAZ; Flexible regimen; Drospirenone; Ethinylestradiol Betadex; Endometriosis; Dienogest; Japanese Patients

Additional relevant MeSH terms:

Endometriosis; Dienogest; Contraceptive Agents, Male; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptives, Oral; Contraceptive Agents, Female; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents