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

Astellas

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: Placebo; Drug: Leuprorelin acetate; Drug: ASP1707

Study type: Interventional

Funder types: Industry

Identifiers

NCT01767090

1707-CL-0011

2012-002791-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 912 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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912 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Applicable to first 12 week period (Part One); subjects in this arm will be randomized to one of the ASP1707 dose levels for the second 12 week period (Part Two)

Treatment:

Drug: Placebo

ASP1707 lowest dose

Experimental group

Description:

Subjects in this arm will be dosed with ASP1707 once daily for a total of 12 weeks (Part One) and continue taking the assigned dose for a further 12 weeks during the extension phase of the study (Part Two) for a total of 24 weeks

Treatment:

Drug: ASP1707

ASP1707 low dose

Experimental group

Description:

Subjects in this arm will be dosed with ASP1707 once daily for a total of 12 weeks (Part One) and continue taking the assigned dose for a further 12 weeks during the extension phase of the study (Part Two) for a total of 24 weeks

Treatment:

Drug: ASP1707

ASP1707 medium dose

Experimental group

Description:

Subjects in this arm will be dosed with ASP1707 once daily for a total of 12 weeks (Part One) and continue taking the assigned dose for a further 12 weeks during the extension phase of the study (Part Two) for a total of 24 weeks

Treatment:

Drug: ASP1707

ASP1707 high dose

Experimental group

Description:

Subjects in this arm will be dosed with ASP1707 once daily for a total of 12 weeks (Part One) and continue taking the assigned dose for a further 12 weeks during the extension phase of the study (Part Two) for a total of 24 weeks

Treatment:

Drug: ASP1707

Leuprorelin acetate

Active Comparator group

Description:

Subjects in this arm will be treated with leuprorelin acetate for a total of 24 weeks

Treatment:

Drug: Leuprorelin acetate