Trial Condition(s):
Endometriosis
Bay98-7196, Dose finding / POC study
Bayer Identifier:
15832
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new treatment option for patients with endometriosis-associated pelvic pain
Inclusion Criteria
- Premenopausal women18 years and above at the time of screening. - Women with endometriosis confirmed by laparoscopy or laparotomy within the last ten years but not less than 8 weeks before the screening visit In Japan, diagnosis based on imaging (transvaginal ultrasound or MRI) also qualifies for inclusion. - Moderate to severe endometriosis-associated pelvic pain (EAPP) of ≥5 in the last 28 days before screening visit 1 measured on the numeric rating scale (NRS; i.e. 4-week recall period). - At randomization: Adherence to the study procedures during the screening period, at least 24 diary entries of ESD item 1 during the last 28 consecutive days before the randomization visit, and a sum of the available ESD item 1 (‘worst pain’ on the daily NRS) entries during this period of at least 98 (corresponding to an average score of ≥ 3.5). - Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator’s instruction. - Use of a non-hormonal barrier method (i.e. spermicide-coated condoms) for contraception from screening visit until the end of the study. This is not required if adequate contraception is achieved by vasectomy of the partner
Exclusion Criteria
-Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment) - Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug - Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results. - Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator. - Undiagnosed abnormal genital bleeding - Wish for pregnancy during the study - Regular use of pain medication due to other underlying diseases - Non-responsiveness of endometriosis associated pelvic pain (EAPP) to GnRH-a or surgery (partial response is not exclusionary).
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Lincoln, United States, 68510 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Plainsboro, United States, 08536 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sevilla, Spain, 41014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Aravaca, Spain, 28023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Pozuelo de Alarcón, Spain, 28223 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Copenhagen, Denmark, 2100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Odense C, Denmark, DK-5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Praha 2, Czech Republic | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Pisek, Czech Republic, 39701 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ceske Budejovice, Czech Republic, 37001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Brno, Czech Republic, 625 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kuopio, Finland, 70100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Turku, Finland, 20520 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Espoo, Finland, 02100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hyvinkää, Finland, 05850 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Jyväskylä, Finland, 40100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Karlsruhe, Germany, 76199 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Bernburg, Germany, 06406 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Köln, Germany, 50931 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Erlangen, Germany, 91054 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hamburg, Germany, 20357 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hamburg, Germany, 22587 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Berlin, Germany, 10787 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Nieuwegein, Netherlands, 3435 CM | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Trondheim, Norway, 7006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Stokmarknes, Norway, 8450 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tromsø, Norway, 9019 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site ZWOLLE, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site GRONINGEN, Netherlands, 9700 RB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Almere, Netherlands | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Barcelona, Spain, 8036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Philadelphia, United States, 19104 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Canton, United States, 48187 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Hamilton, Canada, L8S 4K1 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Quebec, Canada, G1S 2L6 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Marrero, United States, 70072 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seattle, United States, 98105 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Villach, Austria, 9500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site San Francisco, United States, 94158-2509 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Leczna, Poland, 21-010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lublin, Poland, 20-632 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Chicago, United States, 60611 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lausanne, Switzerland, 1011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sapporo, Japan, 060-0031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sapporo, Japan, 060-0061 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sapporo, Japan, 006-8555 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kanazawa, Japan, 920-8530 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Osakasayama, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kurashiki, Japan, 710-0824 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kitakyushu, Japan, 800-0296 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tønsberg, Norway, 3111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Minatoku, Japan, 107-0052 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bunkyo-ku, Japan, 113-8431 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hamamatsu, Japan, 430-0929 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Shinagawa-ku, Japan, 141-8625 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sapporo, Japan, 060-0807 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Osaka, Japan, 543-0023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Olomouc, Czech Republic, 772 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Brno, Czech Republic, 602 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Helsinki, Finland, 00510 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kumamoto, Japan, 861-8520 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Luzern, Switzerland, 6000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site New Port Richey, United States, 34652 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Frauenklinik, Switzerland | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kawanishi, Japan, 666-0125 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Dayton, United States, 45409 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Nagano, Japan, 381-8551 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ottawa, Canada, K1H 7W9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Jena, Germany, 07743 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Blankenburg, Germany, 38889 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lodz, Poland, 90-602 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Asker, Norway, 1383 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Collado Villalba, Spain, 28400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Vitoria, Spain, 01009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Palos Heights, United States, 60463 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Durham, United States, 27713 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Columbus, United States, 43213 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Wichita, United States, 67226 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Atlanta, United States, 30338 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Mannheim, Germany, 68165 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site München, Germany, 81675 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Saginaw, United States, 48604 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hradec Kralove, Czech Republic, 500 03 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tabor, Czech Republic, 39003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Plzen, Czech Republic, 326 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Aachen, Germany, 52074 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Szczecin, Poland, 71-434 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Detroit, United States, 48034 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Greensboro, United States, 27408 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Gainesville, United States, 32605 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A randomized, double-blind, double-dummy, parallel- group, multi-center phase IIb study to assess the efficacy and safety of different dose combinations of an aromatase inhibitor and a progestin in an intravaginal ring versus placebo and leuprorelin / leuprolide acetate in women with symptomatic endometriosis over a 12-week treatment period
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
6
Primary Outcome
- Absolute change in mean pain of the 7 days with worst endometriosis associated pelvic pain (EAPP) from baseline (last 28 days before randomization) to end of treatment (last 28 days of the treatment period).Timeframe: baseline (last 28 days before randomization) versus end of treatment (last 28 days of the treatment period, Day 57 - 84)
Secondary Outcome
- Absolute change in mean pain of the 7 days with worst endometriosis associated pelvic pain (EAPP) from baseline (last 28 days before randomization) to the first cycle under study treatment (Day 1 - 28) and to the second cycle under study treatment.Timeframe: baseline (last 28 days before randomization) vs the first cycle under study treatment (Day 1 - 28) and vs the second cycle under study treatment (Day 29 - 56)
- Absolute change in mean pain from baseline (last 28 days before randomization) to the first cycle under study treatment (Day 1 - 28), the second cycle under study treatment (Day 29 - 56), and to the third cycle under study treatment (Day 57 - 84)Timeframe: baseline (last 28 days before randomization) vs the first cycle under study treatment (Day 1 - 28), the second cycle under study treatment (Day 29 - 56), and the third cycle under study treatment (Day 57 - 84)
- Number of days during baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 7 (measured on the NRS by Question 1 of the ESD)Timeframe: baseline (last 28 days before randomization) and Cycles 1, 2, and 3
- Change of days from baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 7 (measured on the NRS by Question 1 of the ESD)Timeframe: baseline (last 28 days before randomization) and Cycles 1, 2, and 3
- Number of days during baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 4 (measured on the NRS by Question 1 of the ESD)Timeframe: baseline (last 28 days before randomization) and Cycles 1, 2, and 3
- Change of days from baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 4 (measured on the NRS by Question 1 of the ESD)Timeframe: baseline (last 28 days before randomization) and Cycles 1, 2, and 3
Additional Information
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