Clinical trial NCT01697111: Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Keywords: YAZ
Flexible regimen
Drospirenone
Ethinylestradiol Betadex
Endometriosis
Dienogest
Japanese Patients
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 312
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24)
timeFrame: Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)
Secondary outcomes:
measure: Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain)
timeFrame: Weeks 17-24 of treatment period
measure: Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain)
timeFrame: Weeks 17-24 of treatment period
measure: Dyspareunia
timeFrame: Weeks 17-24 of treatment period
measure: Average of pain
timeFrame: Weeks 17-24 of treatment period
measure: Size of chocolate cyst
timeFrame: 24 weeks after taking the initial study medication
measure: Endometrial thickness
timeFrame: 24 weeks after taking the initial study medication
measure: Number of days with spotting/bleeding
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Anjo
country: Japan
state: Aichi
city: Ichinomiya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Matsudo
country: Japan
state: Chiba
city: Takasaki
country: Japan
state: Gunma
city: Itami
country: Japan
state: Hyogo
city: Kawanishi
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Kanazawa
country: Japan
state: Ishikawa
city: Kamakura
country: Japan
state: Kanagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Toyonaka
country: Japan
state: Osaka
city: Kitamoto
country: Japan
state: Saitama
city: Bunkyo
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Fuchu
country: Japan
state: Tokyo
city: Hachioji
country: Japan
state: Tokyo
city: Itabashi
country: Japan
state: Tokyo
city: Machida
country: Japan
state: Tokyo
city: Minato
country: Japan
state: Tokyo
city: Minato
country: Japan
state: Tokyo
city: Nishitokyo
country: Japan
state: Tokyo
city: Fukui
country: Japan
city: Fukui
country: Japan
city: Gifu
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Harada T, Kosaka S, Elliesen J, Yasuda M, Ito M, Momoeda M. Ethinylestradiol 20 mug/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.