NCT01697111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 18, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

September 28, 2012

Last Update Submit

February 16, 2016

Conditions

Endometriosis

Keywords

YAZFlexible regimenDrospirenoneEthinylestradiol BetadexEndometriosisDienogestJapanese Patients

Outcome Measures

Primary Outcomes (1)

  • Change of pelvic pain from baseline period (8 weeks before start of treatment) to 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)

    Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)

Secondary Outcomes (7)

  • Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain)

    Weeks 17-24 of treatment period

  • Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain)

    Weeks 17-24 of treatment period

  • Dyspareunia

    Weeks 17-24 of treatment period

  • Average of pain

    Weeks 17-24 of treatment period

  • Size of chocolate cyst

    24 weeks after taking the initial study medication

  • +2 more secondary outcomes

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: EE20/DRSP(BAY86-5300)

Arm 2

EXPERIMENTAL
Drug: Placebo

Arm 3

ACTIVE COMPARATOR
Drug: Dienogest

Interventions

EE20/DRSP(BAY86-5300)DRUG

One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day

Arm 1
PlaceboDRUG

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

Arm 2
DienogestDRUG

Dienogest 1mg twice a day (bid)

Arm 3

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Unknown Facility

Anjo, Aichi-ken, 446-8510, Japan

Location

Unknown Facility

Ichinomiya, Aichi-ken, 491-8551, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 451-8511, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 460-0011, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 464-0066, Japan

Location

Unknown Facility

Matsudo, Chiba, 270-2267, Japan

Location

Unknown Facility

Fukui-shi, Fukui, 910-0845, Japan

Location

Unknown Facility

Fukui-shi, Fukui, 910-8526, Japan

Location

Unknown Facility

Gifu, Gifu, 500-8717, Japan

Location

Unknown Facility

Takasaki, Gunma, 370-0883, Japan

Location

Unknown Facility

Itami, Hyōgo, 664-8540, Japan

Location

Unknown Facility

Kawanishi, Hyōgo, 666-0125, Japan

Location

Unknown Facility

Kobe, Hyōgo, 654-0047, Japan

Location

Unknown Facility

Kanazawa, Ishikawa-ken, 920-8530, Japan

Location

Unknown Facility

Kamakura, Kanagawa, 247-8533, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, 212-0016, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 230-0001, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 231-0023, Japan

Location

Unknown Facility

Osaka, Osaka, 530-0001, Japan

Location

Unknown Facility

Osaka, Osaka, 530-0013, Japan

Location

Unknown Facility

Osaka, Osaka, 542-0086, Japan

Location

Unknown Facility

Toyonaka, Osaka, 560-0022, Japan

Location

Unknown Facility

Kitamoto, Saitama, 364-8501, Japan

Location

Unknown Facility

Bunkyo, Tokyo, 112-0014, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, 104-0061, Japan

Location

Unknown Facility

Fuchū, Tokyo, 183-0056, Japan

Location

Unknown Facility

Hachiōji, Tokyo, 192-0046, Japan

Location

Unknown Facility

Machida, Tokyo, 194-0022, Japan

Location

Unknown Facility

Minato, Tokyo, 105-0001, Japan

Location

Unknown Facility

Minato, Tokyo, 107-0051, Japan

Location

Unknown Facility

Nishitōkyō, Tokyo, 188-0011, Japan

Location

Unknown Facility

tabashi City, Tokyo, 175-0092, Japan

Location

Related Publications (1)

  • 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.

    PMID: 28911925DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

dienogest

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2012

First Posted

October 2, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

December 1, 2014

Last Updated

February 18, 2016

Record last verified: 2016-01

Locations

JP(32)