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Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb (SCHUMANN)

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ClinicalTrials.gov Identifier: NCT04614246
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

The purpose of this study is to assess safety and efficacy of BAY1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include:

  • Study duration: 155 up to 285 days
  • Treatment duration: 84 days
  • Visit frequency: approximately once a month

Condition or disease Intervention/treatment Phase
Endometriosis Drug: BAY1817080 Drug: Elagolix Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind to placebo and open-label for active comparator
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Open for Active Comparator, Parallel-group, Multicenter Phase 2b Study to Assess the Efficacy and Safety of Three Different Doses of P2X3 Antagonist (BAY1817080) Versus Placebo and Elagolix 150 mg in Women With Symptomatic Endometriosis
Actual Study Start Date : January 29, 2021
Estimated Primary Completion Date : August 19, 2022
Estimated Study Completion Date : September 26, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
Drug Information available for: Elagolix

Arm Intervention/treatment
Experimental: BAY1817080 150 mg
Participants will receive 150 mg of BAY1817080 twice daily over a 12-week intervention period
Drug: BAY1817080
Tablet, oral administration

Experimental: BAY1817080 75 mg
Participants will receive 75 mg of BAY1817080 twice daily over a 12-week intervention period
Drug: BAY1817080
Tablet, oral administration

Experimental: BAY1817080 25 mg
Participants will receive 25 mg of BAY1817080 twice daily over a 12-week intervention period
Drug: BAY1817080
Tablet, oral administration

Active Comparator: Elagolix
Participants will receive 150 mg of Elagolix once daily over a 12-week intervention period
Drug: Elagolix
Tablet, oral administration

Placebo Comparator: Placebo
Participants will receive placebo matching BAY1817080 twice daily over a 12-week intervention period
Drug: Placebo
Tablet, oral administration




Primary Outcome Measures :
  1. Absolute change in mean worst EAPP from baseline to end of intervention [ Time Frame: At baseline (last 28 days before start of study drug) and at day 57-84 (+3) ]
    Endometriosis associated pelvic pain (EAPP) will be measured daily on the numerical rating scale (NRS) ranging from 0 to 10 by item 1 of the Endometriosis Symptom Diary (ESD). The higher number indicates a higher level of pain experience


Secondary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events [ Time Frame: Up to 98 days ]
    Any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must be ≥ 18 years of age at the time of signing the informed consent
  • Visually-confirmed endometriosis: detection of endometriotic lesions during laparoscopy or laparotomy (with or without pathological diagnosis) within 10 years but no less than 8 weeks from Visit 1a (surgically diagnosed endometriosis). For Japan only and limited to no more than half of all randomized Japanese participants: the diagnosis can be based on previous imaging (i.e. endometriosis lesion detected by ultrasound or MRI). If the participant was diagnosed by ultrasound, the lesion must be visualized again by ultrasound at the screening visit. If the participant was diagnosed by MRI, the diagnosis must have been made within 12 months before Visit 1a (clinically diagnosed endometriosis).
  • Both sub-criteria regarding pain symptoms must be fulfilled:

    • At Visit 1a, participant presents self-reported moderate to severe pain which - based on the judgement of the investigator - carries a reasonable likelihood to translate into a severity of pain symptoms sufficient to fulfil the eligibility criterion and be caused by endometriosis, and
    • During the screening period at least 24 daily ESD entries during the 28 consecutive days starting on the first day with menstrual bleeding at or after Visit 1a and entries in the ESD item 1a ('worst pain' on the daily numerical rating scale) sum up to 98 or more.
  • Willingness to use standardized rescue pain medications for EAPP (i.e. ibuprofen, acetaminophen and tramadol) and not use any prophylactic pain medication, according to investigator's instruction
  • Ability to swallow the study intervention, i.e., the different kinds of tablets, as complete units
  • Good general health (except for findings related to endometriosis) as proven by medical history, physical and gynecological examinations and laboratory test results
  • Normal or clinically insignificant cervical cytology not requiring further follow-up:

    • A cervical cytology sample has to be obtained during screening, or
    • A documented normal result has to be available from cervical cytology conducted within 12 months prior to Visit 1a.
    • Human papilloma virus (HPV) testing in participants with atypical squamous cells of unknown significance (ASCUS) will be used as an adjunctive test automatically. Participants with ASCUS can be included if they are negative for high-risk HPV strains.

Exclusion Criteria:

  • Current pregnancy or less than 3 months since delivery, abortion or stop of lactation before Visit 1a
  • Hypersensitivity to any ingredient of the study intervention and/or the standardized rescue medications
  • Known osteoporosis
  • History of a low trauma fracture
  • Contraindications for elagolix or the standardized rescue medications
  • Current malignancy or history of cancer (exception: basal cell or squamous cell carcinoma of the skin) within the last 5 years prior to Visit 1a
  • Any other disease or condition that, according to the investigator, can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study intervention (e.g. chronic bowel diseases, Crohn's disease and ulcerative colitis)
  • Menopause or signs of menopausal transition, such as absence of regular menstrual cycles based on investigator's judgment (absence of information regarding menstrual bleeding pattern e.g. due to long term use of hormonal contraception is not an exclusion criterion)
  • Any disease or condition that may worsen during the study period according to the assessment and opinion of the investigator
  • Abnormal uterine bleeding in terms of regularity or heaviness (with the exception of heavy menstrual bleeding that does not require treatment)
  • Any findings that require further diagnostic procedures to avoid harm to the participant (e.g. ovarian tumors of uncertain origin or pelvic masses of unclear etiology)
  • Any serious or unstable diseases or medical conditions, including psychiatric disorders, that might interfere with the conduct of the study or the interpretation of the result, including for example:

    • history of hysterectomy and/or bilateral oophorectomy
    • any conditions considered to contribute significantly to pelvic pain by the investigator, e.g. fibromyalgia, uterine fibroids, irritable bowel syndrome or other bowel disorders
    • any other underlying diseases requiring regular use of pain medication (e.g. migraine)
    • history of or current anxiety or depression unless stable with or without medical treatment ≥ 6 months before Visit 1a
  • Major surgery scheduled during the study period
  • Non-responsiveness of EAPP to earlier treatment with GnRH-agonists or GnRH-antagonists, based on the judgement of the investigator
  • SARS-CoV-2- positive virus RNA test within 4 weeks prior to Visit 1a reported by participant, regardless of whether the participant had symptoms
  • History of COVID-19 infection with persistent/ongoing symptoms
  • Contact with SARS-CoV-2- positive or COVID-19 patient within the last 4 weeks prior to Visit 1a
  • Intake of medication prohibited due to potential drug-drug interaction
  • Use of other treatments that might interfere with the conduct of the study or the interpretation of the results, including:

    • hormonal medications
    • other treatments intended for endometriosis/pelvic pain during participation in the study, including the use of herbal products or traditional Chinese medicine for symptom relief, with the exception of the standardized rescue pain medications
  • Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial 3 months prior to Visit 1a that might have an impact on the study objectives, at the discretion of the investigator
  • Previous assignment to study intervention (randomization) in this study (allowing previously randomized participants to be re-included into the study may lead to bias)
  • Laboratory values outside the inclusion range (specified in the laboratory manual) and considered clinically relevant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614246


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04614246    
Other Study ID Numbers: 20584
2020-003131-16 ( EudraCT Number )
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis