Bay98-7196, Dose Finding / POC Study

Bayer

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: Placebo; Drug: Anastrozole; Drug: Levonorgestrel; Drug: Lupron / Leuprolide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02203331

2013-005090-53 (EudraCT Number)

15832

Details and patient eligibility

About

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

Enrollment: 319 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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319 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Levonorgestrel

Experimental group

Description:

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

Treatment:

Drug: Levonorgestrel

Drug: Placebo

Anastrozole 300 µg/d + Levonorgestrel

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Anastrozole

Anastrozole 600 µg/d + Levonorgestrel

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Anastrozole

Anastrozole 1050 µg/d + Levonorgestrel

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Anastrozole

Lupron / Leuprolide acetate

Active Comparator group

Description:

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

Treatment:

Drug: Lupron / Leuprolide acetate

Drug: Placebo