Bay98-7196, Dose Finding / POC Study

• Status: Completed
• Trial end date: 2016-10-24
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Anastrozole; Leuprolide; Levonorgestrel

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).