check_circleStudy Completed

Endometriosis

Bayer Identifier:

15832

ClinicalTrials.gov Identifier:

NCT02203331

EudraCT Number:

2013-005090-53

EU CT Number:

Not Available
Bay98-7196, Dose finding / POC study

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

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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
  • -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
319
Trial Dates
October 2014 - October 2016
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Anastrozole and Levonorgestrel (BAY98-7196)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Clearwater, 33761, United States
Completed
Lincoln, 68510, United States
Withdrawn
Augusta, 30912, United States
Completed
Plainsboro, 08536, United States
Withdrawn
Miami, 33176, United States
Withdrawn
Siena, 53100, Italy
Withdrawn
Pavia, 27100, Italy
Withdrawn
Brescia, 25123, Italy
Withdrawn
Genova, 16132, Italy
Completed
Sevilla, 41014, Spain
Completed
Aravaca, 28023, Spain
Completed
Pozuelo de Alarcón, 28223, Spain
Completed
Copenhagen, 2100, Denmark
Completed
Odense C, DK-5000, Denmark
Completed
Aarhus N, 8200, Denmark
Completed
Praha 2, Czechia
Completed
Pisek, 39701, Czechia
Completed
Ceske Budejovice, 37001, Czechia
Completed
Brno, 625 00, Czechia
Completed
Wien, 1090, Austria
Withdrawn
Salzburg, 5020, Austria
Completed
Linz, 4020, Austria
Completed
Innsbruck, 6020, Austria
Completed
Bern, 3010, Switzerland
Withdrawn
Zürich, 8091, Switzerland
Completed
Kuopio, 70100, Finland
Completed
Turku, 20520, Finland
Completed
Espoo, 02100, Finland
Completed
Hyvinkää, 05850, Finland
Completed
Jyväskylä, 40100, Finland
Completed
Karlsruhe, 76199, Germany
Completed
Dippoldiswalde, 01744, Germany
Completed
Bernburg, 06406, Germany
Completed
Köln, 50931, Germany
Completed
Erlangen, 91054, Germany
Completed
Hamburg, 20357, Germany
Completed
Hamburg, 22587, Germany
Completed
Berlin, 10787, Germany
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
EDEGEM, 2650, Belgium
Completed
BRUXELLES - BRUSSEL, 1000, Belgium
Completed
GENT, 9000, Belgium
Completed
Nieuwegein, 3435 CM, Netherlands
Completed
Trondheim, 7006, Norway
Completed
Stokmarknes, 8450, Norway
Completed
Tromsø, 9019, Norway
Completed
ZWOLLE, 8025 AB, Netherlands
Completed
GRONINGEN, 9700 RB, Netherlands
Completed
Almere, Netherlands
Withdrawn
Feldkirch, 6807, Austria
Completed
Barcelona, 8036, Spain
Completed
Philadelphia, 19104, United States
Completed
Canton, 48187, United States
Completed
Neptune, 07754, United States
Completed
Hamilton, L8S 4K1, Canada
Completed
Quebec, G1S 2L6, Canada
Completed
Montreal, H4P 2S4, Canada
Completed
Toronto, M5C 2T2, Canada
Completed
Marrero, 70072, United States
Completed
Seattle, 98105, United States
Completed
San Diego, 92108, United States
Withdrawn
New York, 10038, United States
Completed
Villach, 9500, Austria
Completed
Barcelona, 08003, Spain
Completed
San Francisco, 94158-2509, United States
Withdrawn
Torrance, 90505, United States
Completed
Sandy Springs, 30328, United States
Withdrawn
New Haven, 06511, United States
Completed
Chattanooga, 37404, United States
Completed
Leczna, 21-010, Poland
Completed
Lublin, 20-632, Poland
Completed
Bialystok, 15- 224, Poland
Completed
Chicago, 60611, United States
Withdrawn
Lugano, 6900, Switzerland
Completed
Lausanne, 1011, Switzerland
Completed
Sapporo, 060-0031, Japan
Completed
Sapporo, 060-0061, Japan
Withdrawn
Turku, 20540, Finland
Completed
Sapporo, 006-8555, Japan
Withdrawn
Omitama, 311-3435, Japan
Completed
Kanazawa, 920-8530, Japan
Completed
Osakasayama, 589-8511, Japan
Completed
Kurashiki, 710-0824, Japan
Completed
Kitakyushu, 800-0296, Japan
Completed
Tønsberg, 3111, Norway
Withdrawn
Kawasaki, 210-0852, Japan
Completed
Minatoku, 107-0052, Japan
Completed
Bunkyo-ku, 113-8431, Japan
Completed
Hamamatsu, 430-0929, Japan
Completed
Shinagawa-ku, 141-8625, Japan
Completed
Sapporo, 060-0807, Japan
Completed
Osaka, 543-0023, Japan
Completed
Olomouc, 772 00, Czechia
Completed
Brno, 602 00, Czechia
Completed
Helsinki, 00510, Finland
Completed
Kumamoto, 861-8520, Japan
Withdrawn
Akashi, 674-0063, Japan
Completed
Luzern, 6000, Switzerland
Completed
New Port Richey, 34652, United States
Completed
Frauenklinik, Switzerland
Completed
Kawanishi, 666-0125, Japan
Completed
Dayton, 45409, United States
Completed
Nagano, 381-8551, Japan
Completed
Berlin, 12200, Germany
Completed
Dresden, 01307, Germany
Completed
Ottawa, K1H 7W9, Canada
Completed
Jena, 07743, Germany
Completed
Blankenburg, 38889, Germany
Completed
Lodz, 90-602, Poland
Completed
Asker, 1383, Norway
Completed
Oulu, 90100, Finland
Completed
Valencia, 46010, Spain
Completed
Valencia, 46014, Spain
Completed
Collado Villalba, 28400, Spain
Completed
Vitoria, 01009, Spain
Completed
Palos Heights, 60463, United States
Withdrawn
Atlanta, 30328, United States
Completed
Durham, 27713, United States
Completed
Columbus, 43213, United States
Completed
Wichita, 67226, United States
Completed
Madison, 53562, United States
Completed
Atlanta, 30338, United States
Completed
Mannheim, 68165, Germany
Completed
München, 81675, Germany
Withdrawn
Fort Myer, 33907, United States
Completed
Saginaw, 48604, United States
Withdrawn
Liege, 4000, Belgium
Completed
Hradec Kralove, 500 03, Czechia
Completed
Tabor, 39003, Czechia
Withdrawn
Hannover, 30625, Germany
Completed
Winston-Salem, 27103, United States
Completed
Plzen, 326 00, Czechia
Completed
Aachen, 52074, Germany
Completed
Szczecin, 71-434, Poland
Completed
Krakow, 31-121, Poland
Completed
Katowice, 40-724, Poland
Completed
Detroit, 48034, United States
Completed
Greensboro, 27408, United States
Completed
Gainesville, 32605, United States
Withdrawn
Ostrava, 700 30, Czechia
Withdrawn
Esslingen, 73730, Germany
Withdrawn
Praha 7, 170 00, Czechia
Withdrawn
Heidelberg, 69120, Germany

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).
    date_rangeTime Frame:
    baseline (last 28 days before randomization) versus end of treatment (last 28 days of the treatment period, Day 57 - 84)
    enhanced_encryption
    Safety Issue:
    No

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.
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    baseline (last 28 days before randomization) and Cycles 1, 2, and 3
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    baseline (last 28 days before randomization) and Cycles 1, 2, and 3
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    baseline (last 28 days before randomization) and Cycles 1, 2, and 3
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    baseline (last 28 days before randomization) and Cycles 1, 2, and 3
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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