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

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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

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

Trial contacts and locations

85

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Data sourced from clinicaltrials.gov

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