Endometriosis MedDRA version: 18.1 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 18.1 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Anastrozole +Levonorgestrel VDS, 50 mg + 170 mg
Product Code: BAY 98-7196
Pharmaceutical Form: Vaginal delivery system
INN or Proposed INN: ANASTROZOLE
CAS Number: 120511-73-1
Current
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent. 2. Premenopausal women18 years and above at the time of screening. 3. 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. 4. 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). 5. 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). 6. Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator’s instruction. 7. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 318 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment) 2. 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 3. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results. 4. Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator. 5. Undiagnosed abnormal genital bleeding 6. Wish for pregnancy during the study 7. Regular use of pain medication due to other underlying diseases 8. Non-responsiveness of endometriosis associated pelvic pain (EAPP) to GnRH-a or surgery (partial response is not exclusionary).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the dose-response relationship and demonstrate efficacy of BAY 98-7196 vs. placebo in women with symptomatic endometriosis.;Secondary Objective: Secondary objectives of this study are To identify at least 1 superior effective dose of BAY 98-7196 compared to placebo To compare the efficacy of BAY 98-7196 vs leuprorelin / leuprolide acetate descriptively To assess sustainability of treatment effect and recurrence of symptoms To evaluate the safety and tolerability of BAY 98-7196 in women with symptomatic endometriosis To explore sub-populations (e.g. subjects with indication for treatment with a gonadotropin-releasing hormone agonist or surgery as judged by the investigator or by endometriosis history and symptom severity) ;Primary end point(s): The primary efficacy variable is the 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 the treatment period, Day 57 - 84).;Timepoint(s) of evaluation of this end point: Baseline (last 28 days before randomization) versus end of treatment (last 28 days of the treatment period, Day 57 – 84). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Absolute change in mean pain of the 7 days with worst EAPP from baseline (last 28 days before randomization) to the first cycle under study treatment (Day 1 - 28) and to the second cycle under study treatment (Day 29 - 56). Absolute change in mean pain from baseline (last 28 days before randomization) to the first cycle under study treatment (Day 1 - 28), the second cycle under study treatment (Day 29 - 56), and to the third cycle under study treatment (Day 57 - 84). Number of days during baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain = 7 (measured on the NRS by Question 1 of the ESD) and change from baseline. Number of days during baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain = 4 (measured on the NRS by Question 1 of the ESD) and change from baseline.;Timepoint(s) of evaluation of this end point: Baseline (last 28 days before randomization) vs the first cycle under study treatment (Day 1 - 28) and to the second cycle under study treatment (Day 29 - 56). Baseline (last 28 days before randomization) vs the first cycle under study treatment (Day 1 - 28), the second cycle under study treatment (Day 29 - 56), and to the third cycle under study treatment (Day 57 - 84). Baseline (last 28 days before randomization) and Cycles 1, 2, and 3. Baseline (last 28 days before randomization) and Cycles 1, 2, and 3. | — |
Countries
Austria, Belgium, Canada, Czech Republic, Denmark, Finland, Germany, Italy, Japan, Netherlands, Norway, Poland, Spain, Switzerland, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed