Bay98-7196, Dose Finding / POC Study

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT02203331
• Date of registration: 28/07/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Bay98-7196, Dose Finding / POC Study
• Scientific 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
• Date of first enrolment: October 16, 2014
• Target sample size: 319
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02203331
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, Canada, Czech Republic, Czechia, Denmark, Finland, Germany, Italy, Japan, Netherlands, Norway, Poland, Spain, Switzerland, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Endometriosis

Intervention(s)

Drug: Levonorgestrel

Drug: Anastrozole

Drug: Lupron / Leuprolide acetate

Drug: Placebo

Primary Outcome(s)

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 [Time Frame: Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)]

Secondary Outcome(s)

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 [Time Frame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)]

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 [Time Frame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)]

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 [Time Frame: 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)]

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 [Time Frame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)]

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 [Time Frame: Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)]

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 [Time Frame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)]

Secondary ID(s)

15832

2013-005090-53

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/01/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02203331