EndometriosisPhase 2AKRENDO1NCT03373422
A Study to Test Whether Study Drug BAY1128688 Brings Pain Relief to Women With Endometriosis and if so to Get a First Idea Which Dose(s) Work Best
A Phase 2 study testing BAY1128688 in people with Endometriosis, run by Bayer at 68 sites in 13 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- BAY1128688
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 68 sitesin 13 countries
- Study dates
- 30 Nov 2017to 22 Oct 2018
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women of at least 18 years of age at the time of signing of informed consent
- Women with endometriosis confirmed by at least one of the two criteria:
- surgery within the last 10 years
- imaging within the last 12 months
- moderate to severe pelvic pain which will be assessed over a period of 28 days
- Willingness to use only ibuprofen as rescue pain medication for endometriosis-associated pelvic pain
- Willingness to use non-hormonal barrier method for contraception (here spermicide-coated condoms) from screening visit until the end of the study (unless adequate contraception is achieved by vasectomy of the partner or use of copper intrauterine device [IUD] or commitment to abstinence) and refrain from using hormonal contraception
Who cannot join
- Pregnancy or lactation (more than three months since delivery, abortion, or lactation before start of treatment) AND no wish for pregnancy during the study
- Altered bilirubin metabolism and liver function at Visit 1
- Requirement to use pain medications for reasons other than endometriosis
- Contraindications to using ibuprofen
- Signs of hyperandrogenism
- Absence of menstrual cycles and/or abnormal vaginal/genital bleeding
- History of hysterectomy, tubal-ligation or bilateral ovariectomy
- Uncontrolled thyroid disorder
Trial locations and contacts
68 sites in 13 countries.
68 sites in 13 countries
Germany10 sites
Praxis Hr. Dr. A. Gerick
Aachen, North Rhine-Westphalia, 52072
Praxis Hr. Dr. S. Fiedler
Aachen, North Rhine-Westphalia, 52074
Praxis Hr. Prof. Dr. A. Ebert
Berlin, 10787
Charité Campus Benjamin Franklin (CBF)
Berlin, 12200
Praxis f. Gynäkologie und Geburtshilfe
Bernburg, Saxony-Anhalt, 06406
Frauenarztpraxis Dr. Wetzel
Blankenburg, Saxony-Anhalt, 38889
Vincentius-Diakonissen-Kliniken gAG
Karlsruhe, Baden-Wurttemberg, 76199
Praxisklinik am Rosengarten
Mannheim, Baden-Wurttemberg, 68165
Klinikum rechts der Isar
München, Bavaria, 81675
Frauenarztpraxis Dr. Wolfgang Clemens
Stolberg, North Rhine-Westphalia, 52222
Hungary8 sites
Semmelweis University
Budapest, 1082
Semmelweis University
Budapest, 1085
Bajcsy Zsilinszky Korhaz-Rendelointezet
Budapest, 1106
Robert Karoly Magankorhaz
Budapest, 1135
NAP - Rendelo, Private Clinic
Debrecen, 4028
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
Szeged, 6725
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000
Italy8 sites
Casa di Cura Privata Malzoni - Villa dei Platani
Avellino, Campania, 83100
A.O.U. di Bologna Policlinico S.Orsola Malpighi
Bologna, Emilia-Romagna, 40138
A.O.U. Careggi
Florence, Tuscany, 50134
IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro
Genoa, Liguria, 16132
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168
A.O.U. Senese
Siena, Tuscany, 53100
A.S.U. Integrata di Udine
Udine, Friuli Venezia Giulia, 33100
A.O.U. Integrata Verona
Verona, Veneto, 37126
Poland8 sites
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, 40-001
Vita Longa Sp. z o.o.
Katowice, 40-748
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
Lodz, 90-602
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
Lublin, 20-064
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie
Lublin, 20-632
VitroLive Sp. z o.o.
Szczecin, 70-483
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434
NZOZ Zieniewicz Medical
Warsaw, 02-201
Czechia6 sites
Gynekologie MEDA s.r.o.
Brno, 602 00
GYN-F s.r.o.
Hradec Králové, 500 03
G-Centrum Olomouc s.r.o. Dr. Skrivanek
Olomouc, 772 00
GynCare MUDr. Michael Svec s.r.o.
Pilsen, 326 00
Centrum gynekologicke rehabilitace
Písek, 39701
Dr. Smrhova-Kovacs
Tábor, 39003
Spain6 sites
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario "La Paz"
Madrid, 28046
Hospital Regional de Málaga
Málaga, 29010
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital General Universitario de Valencia
Valencia, 46014
Austria4 sites
Medizinische Universität Graz
Graz, Styria, 8036
Landeskrankenhaus - Universitätskliniken Innsbruck
Innsbruck, 6020
Kepler Universitätsklinikum
Linz, Upper Austria, 4020
Allgemeines Krankenhaus der Stadt Wien
Vienna, 1090
Belgium4 sites
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, 1200
Ziekenhuis Oost-Limburg
Genk, 3600
AZ Jan Palfijn Gent
Ghent, Oost-Vlaanderen, 9000
CHU de Tivoli
La Louvière, 7100
Finland4 sites
HUS / Naistenklinikka
Helsinki, 00290
Keski-Suomen keskussairaala
Jyväskylä, 40620
Lääkäriasema Cantti Oy
Kuopio, 70110
Lääkärikeskus Gyneko
Oulu, 90100
United Kingdom4 sites
Liverpool Womens Hospital
Liverpool, L8 7SS
Norfolk and Norwich Hospital
Norwich, NR4 7UY
Whiston Hospital
Prescot, L35 5DR
York Teaching Hospital NHS Foundation Trust
York, North Yorkshire, YO318HE
Denmark2 sites
Aarhus Universitetshospital, Skejby
Aarhus N, 8200
H:S Rigshospitalet
København Ø, DK-2100
France2 sites
Centre Hospitalier Universitaire - Angers
Angers, 49100
Cochin - Paris
Paris, 75674
Netherlands2 sites
Flevoziekenhuis
Almere Stad, 1315 RA
Isala
Zwolle, 8025 AB
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center, Exploratory Dose-response Study to Assess the Efficacy and Safety of Different Oral Doses of BAY1128688 in Women With Symptomatic Endometriosis Over a 12-week Treatment Period
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.
- Conditions
- Endometriosis
- Being tested
- BAY1128688, Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1128688Drug
Various dosing OD (once daily) and BID (twice daily)
PlaceboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| BAY1128688 (dose 1) | Experimental | One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening Receives: Drug: BAY1128688; Drug: Placebo |
| BAY1128688 (dose 2) | Experimental | One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening Receives: Drug: BAY1128688; Drug: Placebo |
| BAY1128688 (dose 3) | Experimental | One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening Receives: Drug: BAY1128688; Drug: Placebo |
| BAY1128688 (dose 4) | Experimental | One BAY1128688 tablet (second intermediate dose) in the morning and one in the evening Receives: Drug: BAY1128688 |
| BAY1128688 (dose 5) | Experimental | One BAY1128688 tablet (highest dose) in the morning and one in the evening Receives: Drug: BAY1128688 |
| Placebo | Placebo comparator | One placebo tablet in the morning and one in the evening Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (1)
Incidence of treatment-emergent adverse events
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start30 Nov 2017
- Primary completion23 Jul 2018
- Study completion22 Oct 2018
Why it stopped: Study BAY1128688/17472 (AKRENDO 1) was terminated early on 20 July 2018 due to hepatotoxicity
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 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
- NCT03373422
- Sponsor's protocol ID
- 17472
- Other IDs
- 2017-000244-18, 2017
- Acronym
- AKRENDO1
- Status last verified
- Oct 2019
- First submitted
- 23 Nov 2017
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hilpert J, Groettrup-Wolfers E, Kosturski H, Bennett L, Barnes CLK, Gude K, Gashaw I, Reif S, Steger-Hartmann T, Scheerans C, Solms A, Rottmann A, Mao G, Chapron C. Hepatotoxicity of AKR1C3 Inhibitor BAY1128688: Findings from an Early Terminated Phase IIa Trial for the Treatment of Endometriosis. Drugs R D. 2023 Sep;23(3):221-237. doi: 10.1007/s40268-023-00427-5. Epub 2023 Jul 9.
PubMed 37422772
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center, Exploratory Dose-response Study to Assess the Efficacy and Safety of Different Oral Doses of BAY1128688 in Women With Symptomatic Endometriosis Over a 12-week Treatment Period
- ClinicalTrials.gov ID
- NCT03373422
- Acronym / sponsor ID
- AKRENDO1 / 17472
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study BAY1128688/17472 (AKRENDO 1) was terminated early on 20 July 2018 due to hepatotoxicity
- Enrolment
- 121 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 14 Dec 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BAY1128688 (dose 1) | Experimental | Drug: BAY1128688, Drug: PlaceboOne BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening |
| BAY1128688 (dose 2) | Experimental | Drug: BAY1128688, Drug: PlaceboOne BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening |
| BAY1128688 (dose 3) | Experimental | Drug: BAY1128688, Drug: PlaceboOne BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening |
| BAY1128688 (dose 4) | Experimental | Drug: BAY1128688One BAY1128688 tablet (second intermediate dose) in the morning and one in the evening |
| BAY1128688 (dose 5) | Experimental | Drug: BAY1128688One BAY1128688 tablet (highest dose) in the morning and one in the evening |
| Placebo | Placebo comparator | Drug: PlaceboOne placebo tablet in the morning and one in the evening |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women of at least 18 years of age at the time of signing of informed consent
- Women with endometriosis confirmed by at least one of the two criteria:
- moderate to severe pelvic pain which will be assessed over a period of 28 days
- Willingness to use only ibuprofen as rescue pain medication for endometriosis-associated pelvic pain
- Willingness to use non-hormonal barrier method for contraception (here spermicide-coated condoms) from screening visit until the end of the study (unless adequate contraception is achieved by vasectomy of the partner or use of copper intrauterine device [IUD] or commitment to abstinence) and refrain from using hormonal contraception
Key exclusion criteria (8 listed)
- Pregnancy or lactation (more than three months since delivery, abortion, or lactation before start of treatment) AND no wish for pregnancy during the study
- Altered bilirubin metabolism and liver function at Visit 1
- Requirement to use pain medications for reasons other than endometriosis
- Contraindications to using ibuprofen
- Signs of hyperandrogenism
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 |
|---|---|---|
| BAY1128688Various dosing OD (once daily) and BID (twice daily) | Drug | BAY1128688 (dose 1), BAY1128688 (dose 2), BAY1128688 (dose 3), BAY1128688 (dose 4), BAY1128688 (dose 5) |
| PlaceboMatching placebo tablets | Drug | BAY1128688 (dose 1), BAY1128688 (dose 2), BAY1128688 (dose 3), Placebo |
Primary outcome
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)
Time frame: 12 weeks
EAPP: endometriosis-associated pelvic pain, measured on the NRS (Numerical Rating Scale) by item 1 of the ESD (Endometriosis Symptom Diary)
1 secondary outcome
Incidence of treatment-emergent adverse events
Time frame: 18 weeks
Results and safety
The study was stopped early (reason given: Study BAY1128688/17472 (AKRENDO 1) was terminated early on 20 July 2018 due to hepatotoxicity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 37422772Hilpert J, Groettrup-Wolfers E, Kosturski H, Bennett L, Barnes CLK, Gude K, Gashaw I, Reif S, Steger-Hartmann T, Scheerans C, Solms A, Rottmann A, Mao G, Chapron C. Hepatotoxicity of AKR1C3 Inhibitor BAY1128688: Findings from an Early Terminated Phase IIa Trial for the Treatment of Endometriosis. Drugs R D. 2023 Sep;23(3):221-237. doi: 10.1007/s40268-023-00427-5. Epub 2023 Jul 9.
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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
68 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY1128688 in people with Endometriosis, run by Bayer at 68 sites in 13 countries.
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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in Germany, Hungary, Italy, Poland, Czechia and 8 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Study BAY1128688/17472 (AKRENDO 1) was terminated early on 20 July 2018 due to hepatotoxicity). Results are not available in the source record.
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?
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) (time frame: 12 weeks). 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 NCT03373422, 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 3 Oct 2019.