search
Back to results

Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Dienogest (Visanne, BAY86-5258)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Efficacy, Safety, Dienogest

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women between 18 and 45 years of age, inclusive
  • Women with endometriosis confirmed by laparoscopy or laparotomy within ten years but no later than 2 weeks before the Screening Visit
  • A score of at least 30 on a 100 mm visual analog scale (VAS) for endometriosis-associated pelvic pain at Screening Visit and Baseline Visit
  • Good general health (except for findings related to endometriosis, with or without infertility), as evidenced by medical history and complete physical and gynecological examination
  • Willingness to use a barrier method of contraception is required

Exclusion Criteria:

  • Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
  • Wish for pregnancy within intended treatment period
  • Before menarche or after menopause
  • Amenorrhea (more than three consecutive months in the six months before screening)
  • Undiagnosed abnormal genital bleeding
  • Previous/use of hormonal agents
  • Any disease or condition that may worsen under hormonal treatment
  • Signs and/or symptoms of therapy-resistant endometriosis despite more than one prior attempt at drug treatment or surgical therapy
  • Need for primary surgical treatment of endometriosis
  • Regular use of pain medication due to other underlying diseases
  • Contra-indication for the supportive analgesic medication (ibuprofen)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dienogest

Placebo

Arm Description

50% of the participants will be randomized to this arm and will receive 2 mg dienogest (DNG) once daily by mouth from 0-52 weeks

50% of the participants will be randomized to this arm and will receive placebo once daily by mouth from 0-24 weeks then switch to 2 mg dienogest (DNG) once daily by mouth from 25-52 weeks

Outcomes

Primary Outcome Measures

Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks

Secondary Outcome Measures

Percentage of treatment responders
Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings)
Quality of life assessed by patient questionnaire
Number of participants with adverse events as a measure of safety and tolerability
Vaginal bleeding intensity recorded by patient diary and measured on a 5-point scale (none, spotting, light, normal, heavy)

Full Information

First Posted
March 11, 2013
Last Updated
November 24, 2015
Sponsor
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT01822080
Brief Title
Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients
Official Title
A Multicenter Study to Investigate the Efficacy and Safety of Daily Oral Administration of 2 mg Dienogest Tablets (Visanne/SH T00660AA) for the Treatment of Endometriosis in Chinese Patients: a Double-blind, Randomized, Placebo-controlled, Parallel Group Phase Over 24 Weeks Followed by an Open-label, Single-group Follow up Over 28 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is aimed to evaluate efficacy and safety of dienogest 2 mg oral tablets in the treatment of endometriosis. There will be 2 study phases: a double-blind, randomized, placebo-controlled, parallel-group phase over 24 weeks, and an open-label extension phase with 2 mg DNG daily p.o. over 28 weeks for all subjects who completed the double-blind phase, irrespective of their treatment assignment in the first study phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Efficacy, Safety, Dienogest

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dienogest
Arm Type
Experimental
Arm Description
50% of the participants will be randomized to this arm and will receive 2 mg dienogest (DNG) once daily by mouth from 0-52 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
50% of the participants will be randomized to this arm and will receive placebo once daily by mouth from 0-24 weeks then switch to 2 mg dienogest (DNG) once daily by mouth from 25-52 weeks
Intervention Type
Drug
Intervention Name(s)
Dienogest (Visanne, BAY86-5258)
Intervention Description
2 mg dienogest (DNG) once daily by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo once daily by mouth
Primary Outcome Measure Information:
Title
Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks
Time Frame
24 weeks after baseline
Secondary Outcome Measure Information:
Title
Percentage of treatment responders
Time Frame
At 24 weeks
Title
Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings)
Time Frame
24 weeks after baseline
Title
Quality of life assessed by patient questionnaire
Time Frame
Up to 24 weeks
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
Up to 52 weeks
Title
Vaginal bleeding intensity recorded by patient diary and measured on a 5-point scale (none, spotting, light, normal, heavy)
Time Frame
Up to 52 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women between 18 and 45 years of age, inclusive Women with endometriosis confirmed by laparoscopy or laparotomy within ten years but no later than 2 weeks before the Screening Visit A score of at least 30 on a 100 mm visual analog scale (VAS) for endometriosis-associated pelvic pain at Screening Visit and Baseline Visit Good general health (except for findings related to endometriosis, with or without infertility), as evidenced by medical history and complete physical and gynecological examination Willingness to use a barrier method of contraception is required Exclusion Criteria: Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment) Wish for pregnancy within intended treatment period Before menarche or after menopause Amenorrhea (more than three consecutive months in the six months before screening) Undiagnosed abnormal genital bleeding Previous/use of hormonal agents Any disease or condition that may worsen under hormonal treatment Signs and/or symptoms of therapy-resistant endometriosis despite more than one prior attempt at drug treatment or surgical therapy Need for primary surgical treatment of endometriosis Regular use of pain medication due to other underlying diseases Contra-indication for the supportive analgesic medication (ibuprofen)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
City
Changchun
State/Province
Jilin
Country
China
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
City
Hangzhou
State/Province
Zhejiang
Country
China
City
Beijing
ZIP/Postal Code
100020
Country
China
City
Beijing
ZIP/Postal Code
100026
Country
China
City
Beijing
ZIP/Postal Code
100029
Country
China
City
Beijing
ZIP/Postal Code
100032
Country
China
City
Beijing
ZIP/Postal Code
100034
Country
China
City
Beijing
ZIP/Postal Code
100038
Country
China
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100083
Country
China
City
Chongqing
ZIP/Postal Code
400010
Country
China
City
Chongqing
ZIP/Postal Code
400016
Country
China
City
Chongqing
ZIP/Postal Code
400042
Country
China
City
Kunming
Country
China
City
Shanghai
ZIP/Postal Code
200011
Country
China
City
Shanghai
ZIP/Postal Code
200030
Country
China
City
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30461337
Citation
Yu Q, Zhang S, Li H, Wang P, Zvolanek M, Ren X, Dong L, Lang J. Dienogest for Treatment of Endometriosis in Women: A 28-Week, Open-Label, Extension Study. J Womens Health (Larchmt). 2019 Feb;28(2):170-177. doi: 10.1089/jwh.2018.7084. Epub 2018 Nov 21.
Results Reference
derived

Learn more about this trial

Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients

We'll reach out to this number within 24 hrs