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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 currently recruiting participants.
Verified January 2013 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe BV )
ClinicalTrials.gov Identifier:
NCT01767090
First received: December 18, 2012
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

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 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) 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: June 2014
Estimated Primary Completion Date: June 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767090

Contacts
Contact: Global Clinical Science +31 (0)71 5455 878 contact@nl.astellas.com

Locations
Japan
2002 Recruiting
Nagaoka, Japan, 940 2085
Sponsors and Collaborators
Astellas Pharma Europe BV
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe BV )
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: January 10, 2013
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, Hormonal
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013