Clinical trial NCT02203331: Bay98-7196, Dose Finding / POC Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 319
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: 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
timeFrame: Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)
Secondary outcomes:
measure: 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
timeFrame: Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
measure: 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
timeFrame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
measure: 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
timeFrame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
measure: Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD
timeFrame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Sandy Springs
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Palos Heights
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Marrero
country: United States
state: Louisiana
city: Canton
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Lincoln
country: United States
state: Nebraska
city: Neptune
country: United States
state: New Jersey
city: Plainsboro
country: United States
state: New Jersey
city: Durham
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Villach
country: Austria
state: Kärnten
city: Linz
country: Austria
state: Oberösterreich
city: Innsbruck
country: Austria
state: Tirol
city: Wien
country: Austria
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Brno
country: Czechia
city: Brno
country: Czechia
city: Ceske Budejovice
country: Czechia
city: Hradec Kralove
country: Czechia
city: Olomouc
country: Czechia
city: Pisek
country: Czechia
city: Plzen
country: Czechia
city: Praha 2
country: Czechia
city: Tabor
country: Czechia
city: Aarhus N
country: Denmark
city: Copenhagen
country: Denmark
city: Odense C
country: Denmark
city: Espoo
country: Finland
city: Helsinki
country: Finland
city: Hyvinkää
country: Finland
city: Jyväskylä
country: Finland
city: Kuopio
country: Finland
city: Oulu
country: Finland
city: Turku
country: Finland
city: Karlsruhe
country: Germany
state: Baden-Württemberg
city: Mannheim
country: Germany
state: Baden-Württemberg
city: Erlangen
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Aachen
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Bernburg
country: Germany
state: Sachsen-Anhalt
city: Blankenburg
country: Germany
state: Sachsen-Anhalt
city: Dippoldiswalde
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Jena
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Kitakyushu
country: Japan
state: Fukuoka
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Kawanishi
country: Japan
state: Hyogo
city: Kanazawa
country: Japan
state: Ishikawa
city: Kurashiki
country: Japan
state: Okayama
city: Osakasayama
country: Japan
state: Osaka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Minatoku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Kumamoto
country: Japan
city: Nagano
country: Japan
city: Osaka
country: Japan
city: Almere
country: Netherlands
city: Groningen
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Zwolle
country: Netherlands
city: Asker
country: Norway
city: Stokmarknes
country: Norway
city: Tromsø
country: Norway
city: Trondheim
country: Norway
city: Tønsberg
country: Norway
city: Bialystok
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Leczna
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Szczecin
country: Poland
city: Aravaca
country: Spain
state: Madrid
city: Collado Villalba
country: Spain
state: Madrid
city: Pozuelo de Alarcón
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Vitoria
country: Spain
state: Álava
city: Lausanne
country: Switzerland
state: Vaud
city: Bern
country: Switzerland
city: Frauenklinik
country: Switzerland
city: Luzern
country: Switzerland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: