endometriosis associated pelvic pain MedDRA version: 17.1 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 100000004872
Conditions
Interventions
Product Code: ASP1707
Pharmaceutical Form: Tablet
INN or Proposed INN: ASP1707
Other descriptive name: ASP1707
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Ph
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - pre menopausal female adults with confirmed length and regular menstrual cycle - surgically diagnosed endometriosis -moderate to severe endometriosis related pain (dysmenorrhea and non-menstrual pelvic pain) 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 504 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - hormonal contraceptives or other drugs with effects on gynecological endocrinology - surgery for endometriosis is within 4 weeks prior to entry - uterine myoma, - abnormal vaginal bleeding, - hysterectomy or bilateral oophorectomy, - pelvic infection - relevant abnormalities at gynecological exam at screening - disease with chronic abdominal pain of nonendometriosis origin - pituitary adenoma - use of drugs metabolized by CYP3A4 or anticoagulants or drugs with effects on BMD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - to assess the efficacy and dose-response relationship of ASP1707 in reduction of endometriosis associated pelvic pain. ;Secondary Objective: - to assess safety and tolerability - to assess PK of ASP1707 - to assess dose response relationship of ASP1707 in reduction of E2 - to assess 24-week efficacy of ASP1707 in reduction of EM associated pain - to assess 24-week safety and tolerability of ASP1707 ;Primary end point(s): - Change from baseline to the end of treatment (EoT) of the mean NRS pain score for overall pelvic pain (dysmenorrhea and non-menstrual pelvic pain). - Change from baseline to the EoT of the mean NRS pain score for dysmenorrhea - Change from baseline to the EoT of the mean NRS pain score for non-menstrual pelvic pain;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline to the end of treatment (EoT) of the mean NRS pain score for overall pelvic pain (dysmenorrhea and non-menstrual pelvic pain). - Change from baseline to the EoT of the mean NRS pain score for dysmenorrhea - Change from baseline to the EoT of the mean NRS pain score for non-menstrual pelvic pain - Change from baseline to the EoT of the mean NRS dyspareunia score. - Occurrence of response (= 30% improvement from baseline of the mean NRS score) at the EoT for overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia. - Change from baseline to the EoT of the mean scores of the Biberoglu and Behrman (B&B) symptom and sign domains. - Change from baseline to the EoT of the use of protocol defined rescue medication. - Change from baseline to the EoT of the mean Pain Interference score (mean of 7 interference items) of the Brief Pain Inventory (BPI). - Patient Global Impression of Change (PGIC) at the end of treatment. - Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score. - Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being). - Change from baseline to the EoT of the Beck's Depression Inventory (BDI)-II score. - Change from baseline to the EoT in the EQ-5D score. ;Timepoint(s) of evaluation of this end point: week 12 and week 24 | — |
Countries
Belgium, Bulgaria, Hungary, Japan, Poland, Ukraine, United Kingdom
Contacts
Public ContactService Desk - Global Clinical Dev.
Astellas Pharma Europe B.V.
Outcome results
None listed