Phase 2
N=319
Bay98-7196, Dose Finding / POC Study
Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT02203331 ↗Enrolled (actual)
319
Serious AEs
3.6%
Results posted
Jan 2018
Primary outcome: Primary: 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 — -1.8974; -1.6061; -2.4014; -2.2653 units on a scale — p=0.3875
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Levonorgestrel (Drug); Anastrozole (Drug); Lupron / Leuprolide acetate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bayer
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-1.8974; -1.6061; -2.4014; -2.2653; -3.7679; -2.293 | 0.3875 |
| SECONDARY 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 |
-0.7582; -0.6849; -1.1463; -1.0000; -1.2071; -0.9048 | 0.231 |
| SECONDARY 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 |
6.0938; 5.7409; 6.3694; 5.7128; 6.3962; 5.6399 | 0.5794 |
| SECONDARY 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 |
35.6034; 27.5659; 40.0813; 23.9322; 28.2015; 25.1742 | — |
| SECONDARY 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 |
-13.6756; -12.5862; -15.0341; -13.3722; -19.8898; -16.0105 | — |
| SECONDARY 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 |
71.8037; 69.3092; 73.8956; 70.6504; 70.2066; 65.9074 | — |
| SECONDARY 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 |
-12.8228; -15.4147; -15.1334; -15.1947; -21.4331; -14.5323 | — |
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).
Data sourced from ClinicalTrials.gov (NCT02203331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.