A Phase 2 interventional study of BAY1128688 and Placebo in Endometriosis, sponsored by Bayer. Terminated at 68 sites in 13 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-03.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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Among 27 studies in Endometriosis by Bayer — none open to participants now, none under way, none of them phase 3. Endometriosis · Bayer.
Among the 27 studies in Endometriosis by Bayer, this one is the 7th largest by enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2017, is one of 6 in phase 2, and was the 16th registered.
921 studies on the registry are indexed under Endometriosis; 267 are open to participants now.
Browse Endometriosis studies →None of the 27 studies in Endometriosis by Bayer is open now. The open studies under Endometriosis, anywhere →
Of the 178 Endometriosis studies recruiting now, 52 (29%) set no upper age limit and 124 (70%) stop at 75 or younger; 18 take children under 18; 39 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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27 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 121 is above the median of 67 across 541 interventional studies indexed under Endometriosis.
Median enrollment 68 across the 20 interventional studies, 895 across the 7 observational. Of the 27 that completed or were terminated, 3 (11%) have results posted.
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Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 27 studies in Endometriosis by Bayer, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women with endometriosis confirmed by at least one of the two criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening
Drug: BAY1128688 · Drug: Placebo
One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening
Drug: BAY1128688 · Drug: Placebo
One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening
Drug: BAY1128688 · Drug: Placebo
One BAY1128688 tablet (second intermediate dose) in the morning and one in the evening
Drug: BAY1128688
One BAY1128688 tablet (highest dose) in the morning and one in the evening
Drug: BAY1128688
One placebo tablet in the morning and one in the evening
Drug: Placebo
Various dosing OD (once daily) and BID (twice daily)
Matching placebo tablets
Absolute change in mean pain of the 7 days with worst EAPP comparing the 28-day baseline cycle (baseline period of daily pain recordings) to the 28-day end of treatment cycle (daily pain recordings during the last 28 days of the treatment period)
EAPP: endometriosis-associated pelvic pain, measured on the NRS (Numerical Rating Scale) by item 1 of the ESD (Endometriosis Symptom Diary)
Time frame: 12 weeks
Incidence of treatment-emergent adverse events
Time frame: 18 weeks
Ran from Nov 2017 to primary completion in Jul 2018, 7 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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