Bay98-7196, Dose Finding / POC Study

NCT02203331 | Completed Phase 2 Results

• 2 other identifiers: 158322013-005090-53
• Study Type: interventional
• Target: 319
• Locations: 14 countries
• Sites: 117

Brief Summary

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

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD

  Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.

  Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)

Secondary Outcomes (6)

• Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD

  Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)

• Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD

  Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56), and third cycle (Treatment 3) (last 28 days of the treatment period, Day 57-84)

• Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD

  Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)

• Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD

  Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)

• Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD

  Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection

Drug: Placebo

Levonorgestrel

EXPERIMENTAL

Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection

Drug: Placebo; Drug: Levonorgestrel

Anastrozole 300 µg/d + Levonorgestrel

EXPERIMENTAL

Anastrozole 300 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection

Drug: Placebo; Drug: Anastrozole

Anastrozole 600 µg/d + Levonorgestrel

EXPERIMENTAL

Anastrozole 600 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection

Drug: Placebo; Drug: Anastrozole

Anastrozole 1050 µg/d + Levonorgestrel

EXPERIMENTAL

Anastrozole 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection

Drug: Placebo; Drug: Anastrozole

Lupron / Leuprolide acetate

ACTIVE COMPARATOR

Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection

Drug: Placebo; Drug: Lupron / Leuprolide acetate

Interventions

Placebo DRUG

Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection

Anastrozole 1050 µg/d + Levonorgestrel; Anastrozole 300 µg/d + Levonorgestrel; Anastrozole 600 µg/d + Levonorgestrel; Levonorgestrel; Lupron / Leuprolide acetate; Placebo

Levonorgestrel DRUG

Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection

Levonorgestrel

Anastrozole DRUG

Participants received Anastrozole 300 µg/d or 600 µg/d or 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection

Anastrozole 1050 µg/d + Levonorgestrel; Anastrozole 300 µg/d + Levonorgestrel; Anastrozole 600 µg/d + Levonorgestrel

Lupron / Leuprolide acetate DRUG

Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection

Lupron / Leuprolide acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal women18 years and above at the time of screening.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (117)

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San Diego, California, 92108, United States

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San Francisco, California, 94158-2509, United States

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Gainesville, Florida, 32605, United States

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New Port Richey, Florida, 34652, United States

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Atlanta, Georgia, 30338, United States

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Sandy Springs, Georgia, 30328, United States

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Chicago, Illinois, 60611, United States

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Palos Heights, Illinois, 60463, United States

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Wichita, Kansas, 67226, United States

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Marrero, Louisiana, 70072, United States

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Canton, Michigan, 48187, United States

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Detroit, Michigan, 48034, United States

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Saginaw, Michigan, 48604, United States

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Lincoln, Nebraska, 68510, United States

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Neptune City, New Jersey, 07754, United States

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Plainsboro, New Jersey, 08536, United States

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Durham, North Carolina, 27713, United States

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Greensboro, North Carolina, 27408, United States

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Winston-Salem, North Carolina, 27103, United States

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Columbus, Ohio, 43213, United States

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Dayton, Ohio, 45409, United States

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Philadelphia, Pennsylvania, 19104, United States

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Chattanooga, Tennessee, 37404, United States

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Seattle, Washington, 98105, United States

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Madison, Wisconsin, 53562, United States

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Villach, Carinthia, 9500, Austria

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Innsbruck, Tyrol, 6020, Austria

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Linz, Upper Austria, 4020, Austria

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Vienna, 1090, Austria

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Bruxelles - Brussel, 1000, Belgium

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Bruxelles - Brussel, 1070, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Hamilton, Ontario, L8S 4K1, Canada

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Ottawa, Ontario, K1H 7W9, Canada

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Toronto, Ontario, M5C 2T2, Canada

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Montreal, Quebec, H4P 2S4, Canada

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Québec, G1S 2L6, Canada

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Brno, 602 00, Czechia

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Brno, 625 00, Czechia

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České Budějovice, 37001, Czechia

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Hradec Králové, 500 03, Czechia

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Olomouc, 772 00, Czechia

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Pilsen, 326 00, Czechia

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Písek, 39701, Czechia

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Prague, Czechia

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Tábor, 39003, Czechia

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Aarhus N, 8200, Denmark

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Copenhagen, 2100, Denmark

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Odense C, DK-5000, Denmark

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Espoo, 02100, Finland

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Helsinki, 00510, Finland

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Hyvinkää, 05850, Finland

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Jyväskylä, 40100, Finland

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Kuopio, 70100, Finland

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Oulu, 90100, Finland

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Turku, 20520, Finland

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Karlsruhe, Baden-Wurttemberg, 76199, Germany

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Mannheim, Baden-Wurttemberg, 68165, Germany

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Erlangen, Bavaria, 91054, Germany

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München, Bavaria, 81675, Germany

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Aachen, North Rhine-Westphalia, 52074, Germany

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Cologne, North Rhine-Westphalia, 50931, Germany

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Dippoldiswalde, Saxony, 01744, Germany

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Dresden, Saxony, 01307, Germany

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Bernburg, Saxony-Anhalt, 06406, Germany

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Blankenburg, Saxony-Anhalt, 38889, Germany

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Jena, Thuringia, 07743, Germany

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Berlin, 10787, Germany

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Berlin, 12200, Germany

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Hamburg, 20357, Germany

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Hamburg, 22587, Germany

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Kitakyushu, Fukuoka, 800-0296, Japan

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Sapporo, Hokkaido, 006-8555, Japan

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Sapporo, Hokkaido, 060-0031, Japan

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Sapporo, Hokkaido, 060-0061, Japan

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Sapporo, Hokkaido, 060-0807, Japan

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Kawanishi, Hyōgo, 666-0125, Japan

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Kanazawa, Ishikawa-ken, 920-8530, Japan

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Kurashiki, Okayama-ken, 710-0824, Japan

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Sayama, Osaka, 589-8511, Japan

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Hamamatsu, Shizuoka, 430-0929, Japan

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Bunkyo-ku, Tokyo, 113-8431, Japan

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Minatoku, Tokyo, 107-0052, Japan

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Shinagawa-ku, Tokyo, 141-8625, Japan

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Kumamoto, 861-8520, Japan

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Nagano, 381-8551, Japan

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Osaka, 543-0023, Japan

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Almere Stad, Netherlands

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Groningen, 9700 RB, Netherlands

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Nieuwegein, 3435 CM, Netherlands

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Zwolle, 8025 AB, Netherlands

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Asker, 1383, Norway

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Stokmarknes, 8450, Norway

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Tromsø, 9019, Norway

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Trondheim, 7006, Norway

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Tønsberg, 3111, Norway

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Bialystok, 15- 224, Poland

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Katowice, 40-724, Poland

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Krakow, 31-121, Poland

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Lodz, 90-602, Poland

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Lublin, 20-632, Poland

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Szczecin, 71-434, Poland

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Łęczna, 21-010, Poland

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Aravaca, Madrid, 28023, Spain

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Collado Villalba, Madrid, 28400, Spain

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Pozuelo de Alarcón, Madrid, 28223, Spain

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Barcelona, 08003, Spain

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Barcelona, 8036, Spain

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Seville, 41014, Spain

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Valencia, 46010, Spain

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Valencia, 46014, Spain

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Vitoria-Gasteiz, Álava, 01009, Spain

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Lausanne, Canton of Vaud, 1011, Switzerland

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Bern, 3010, Switzerland

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Frauenklinik, Switzerland

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Lucerne, 6000, Switzerland

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Related Links

• Click here to find information about studies related to Bayer AG products conducted in Europe.

MeSH Terms

Conditions

Endometriosis

Interventions

Levonorgestrel; Anastrozole; Leuprolide

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 29, 2014
• Study Start: October 16, 2014
• Primary Completion: October 24, 2016
• Study Completion: October 24, 2016
• Last Updated: November 7, 2023
• Results First Posted: January 4, 2018

Record last verified: 2023-11

Locations

DK (3); FI (7); AU (4); BE (4); DE (15); JP (16); NL (4); NO (5); PL (7); ES (9); CH (4); CZ (9); CA (5); US (25)