Status:
COMPLETED
Bay98-7196, Dose Finding / POC Study
Lead Sponsor:
Bayer
Conditions:
Endometriosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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
- 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
- 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).
Key Trial Info
Start Date :
October 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2016
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT02203331
Start Date
October 16 2014
End Date
October 24 2016
Last Update
November 7 2023
Active Locations (117)
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1
San Diego, California, United States, 92108
2
San Francisco, California, United States, 94158-2509
3
Gainesville, Florida, United States, 32605
4
New Port Richey, Florida, United States, 34652