A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain

Astellas Pharma Europe B.V.912 enrolled

Overview

The main objective for this study is to assess the efficacy and dose-response relationship of ASP1707 in reduction of endometriosis associated pelvic pain. The secondary objectives are to assess the safety, tolerability, Pharmacokinetics of ASP1707, dose response relationship of ASP1707 in reduction of E2 (Estradiol), 24-week efficacy of ASP1707 in reduction of endometriosis associated pain and 24-week safety and tolerability of ASP1707.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

912

Conditions

Endometriosis

Interventions

ASP1707DRUG

Oral

PlaceboDRUG

Oral

Leuprorelin acetateDRUG

subcutaneous

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pre menopausal female adults with confirmed length and regular menstrual cycle * Surgically diagnosed endometriosis * Moderate to severe endometriosis related pain Exclusion Criteria: * Hormonal contraceptives or other drugs with effects on gynecological endocrinology * Surgery for endometriosis within the 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 non-endometriosis origin * Pituitary adenoma

Locations (85)

Outcomes

Primary Outcomes

Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain

Time frame: Baseline & Week 12

Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea

Time frame: Baseline & Week 12

Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain

Time frame: Baseline & Week 12

Secondary Outcomes

Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain

Time frame: Baseline & Week 24

Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea

Time frame: Baseline & Week 24

Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain

Time frame: Baseline & Week 24

Change from baseline to the end of treatment (EoT) of the dyspareunia score

Time frame: Baseline, Week 12 & Week 24

Occurrence of response at the EoT for pain score for overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia

Time frame: Week 12 & Week 24

Change from baseline to the EoT of the mean scores of the modified Biberoglu and Behrman (B&B) symptom and sign domains

Time frame: Baseline, Week 12 & Week 24

Change from baseline to the EoT of the use of protocol defined rescue medication

Data from ClinicalTrials.gov

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