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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01767090
First received: December 18, 2012
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Endometriosis
Drug: ASP1707
Drug: Placebo
Drug: Leuprorelin acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Dose-Response Relationship of ASP1707 in Subjects With Endometriosis Associated Pelvic Pain for 12 Weeks, Followed by a 12-Week Double-blind Extension Without Placebo Control, Including a 24-Week Open-Label Leuprorelin Acetate Treatment Group for Bone Mineral Density Assessment

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain [ Time Frame: Baseline & Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea [ Time Frame: Baseline & Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain [ Time Frame: Baseline & Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain [ Time Frame: Baseline & Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea [ Time Frame: Baseline & Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain [ Time Frame: Baseline & Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline to the end of treatment (EoT) of the dyspareunia score [ Time Frame: Baseline, Week 12 & Week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline to the EoT of the use of protocol defined rescue medication [ Time Frame: Baseline, Week 12 & Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline to the EoT of the mean Pain Interference score of the Brief Pain Inventory [ Time Frame: Baseline, Week 12 & Week 24 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) at the End of Treatment [ Time Frame: Week 12 & Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score [ Time Frame: Baseline, Week 12 & Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being) [ Time Frame: Baseline, Week 12 & Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline to the EoT of the Beck's Depression Inventory (BDI)-II score [ Time Frame: Baseline, Week 12 & Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline to the EoT in the EuroQol (EQ-5D-5L) score [ Time Frame: Baseline, Week 12 & Week 24 ] [ Designated as safety issue: No ]
  • Safety and tolerability of ASP1707 measured by Adverse Events (AEs), bleeding patterns, Bone Mineral Density (BMD) [ Time Frame: Up to Week 42 ] [ Designated as safety issue: No ]
  • Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile of ASP1707 [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Both CL/F, V/F, AUCtau, Cmax, Ctrough


Estimated Enrollment: 600
Study Start Date: December 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Applicable to first 12 week period; subjects in this arm will be randomized to one of the ASP1707 dose levels for the second 12 week period
Drug: Placebo
Oral
Experimental: ASP1707 lowest dose Drug: ASP1707
Oral
Experimental: ASP1707 low dose Drug: ASP1707
Oral
Experimental: ASP1707 medium dose Drug: ASP1707
Oral
Experimental: ASP1707 high dose Drug: ASP1707
Oral
Active Comparator: Leuprorelin acetate Drug: Leuprorelin acetate
subcutaneous
Other Name: Prostap® SR

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767090

  Show 79 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier: NCT01767090     History of Changes
Other Study ID Numbers: 1707-CL-0011, 2012-002791-14
Study First Received: December 18, 2012
Last Updated: September 29, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Agency for Medicines and Medical Devices
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Endometriosis
ASP1707
Pelvic pain
Double-blind
Placebo-controlled
Phase 2

Additional relevant MeSH terms:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Signs and Symptoms
Leuprolide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014