EndometriosisPhase 3NCT01822080
Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients
A Phase 3 study testing Dienogest (Visanne, BAY86-5258) in people with Endometriosis, run by Bayer at 26 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Dienogest (Visanne, BAY86-5258)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 26 sitesChina
- Study dates
- Mar 2013to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Study site
Beijing, 100020
Study site
Beijing, 100026
Study site
Beijing, 100029
Study site
Beijing, 100032
Study site
Beijing, 100034
Study site
Beijing, 100038
Study site
Beijing, 100044
Study site
Beijing, 100083
Study site
Changchun, Jilin
Study site
Chengdu, Sichuan, 610041
Study site
Chengdu, Sichuan, 610072
Study site
Chongqing, 400010
Study site
Chongqing, 400016
Study site
Chongqing, 400042
Study site
Dalian, Liaoning, 116011
Study site
Guangzhou, Guangdong, 510120
Study site
Hangzhou, Zhejiang
Study site
Hengyang, Hunan, 421001
Study site
Kunming
Study site
Shanghai, 200011
Study site
Shanghai, 200030
Study site
Shanghai, 200127
Study site
Shenyang, Liaoning, 110004
Study site
Shijiazhuang, Hebei, 050000
Study site
Wuhan, Hubei, 430030
Study site
Xi'an, Shaanxi, 710061
About this study
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
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.
- Conditions
- Endometriosis
- Being tested
- Dienogest (Visanne, BAY86-5258), Placebo
- Keywords
- Endometriosis, Efficacy, Safety, Dienogest
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dienogest (Visanne, BAY86-5258)Drug
2 mg dienogest (DNG) once daily by mouth
PlaceboDrug
Matching placebo once daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| Dienogest | Experimental | 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 Receives: Drug: Dienogest (Visanne, BAY86-5258) |
| Placebo | Placebo comparator | 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 Receives: Drug: Dienogest (Visanne, BAY86-5258); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks
Measured: 24 weeks after baseline
Secondary outcomes (5)
Percentage of treatment responders
Measured: At 24 weeks
Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings)
Measured: 24 weeks after baseline
Quality of life assessed by patient questionnaire
Measured: Up to 24 weeks
Number of participants with adverse events as a measure of safety and tolerability
Measured: Up to 52 weeks
Vaginal bleeding intensity recorded by patient diary and measured on a 5-point scale (none, spotting, light, normal, heavy)
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822080
- Sponsor's protocol ID
- 13390
- Status last verified
- Nov 2015
- First submitted
- 11 Mar 2013
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30461337
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01822080
- Acronym / sponsor ID
- 13390
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Efficacy, Safety, Dienogest
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dienogest | Experimental | Drug: Dienogest (Visanne, BAY86-5258)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 |
| Placebo | Placebo comparator | Drug: Dienogest (Visanne, BAY86-5258), Drug: Placebo50% 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dienogest (Visanne, BAY86-5258)2 mg dienogest (DNG) once daily by mouth | Drug | Dienogest, Placebo |
| PlaceboMatching placebo once daily by mouth | Drug | Placebo |
Primary outcome
Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks
Time frame: 24 weeks after baseline
5 secondary outcomes
Percentage of treatment responders
Time frame: At 24 weeks
Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings)
Time frame: 24 weeks after baseline
Quality of life assessed by patient questionnaire
Time frame: Up to 24 weeks
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 52 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- Derived from this study: PubMed 30461337Yu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dienogest (Visanne, BAY86-5258) in people with Endometriosis, run by Bayer at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks (time frame: 24 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01822080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015; AzTrials last refreshed its copy on 8 Nov 2026.