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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01767090
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

Brief Summary:
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 or disease Intervention/treatment Phase
Endometriosis Drug: ASP1707 Drug: Placebo Drug: Leuprorelin acetate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 912 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : December 4, 2012
Actual Primary Completion Date : May 13, 2015
Actual Study Completion Date : July 30, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
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)
Drug: Placebo
Oral

Experimental: ASP1707 lowest dose
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
Drug: ASP1707
Oral

Experimental: ASP1707 low dose
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
Drug: ASP1707
Oral

Experimental: ASP1707 medium dose
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
Drug: ASP1707
Oral

Experimental: ASP1707 high dose
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
Drug: ASP1707
Oral

Active Comparator: Leuprorelin acetate
Subjects in this arm will be treated with leuprorelin acetate for a total of 24 weeks
Drug: Leuprorelin acetate
subcutaneous
Other Name: Prostap® SR




Primary Outcome Measures :
  1. Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain [ Time Frame: Baseline & Week 12 ]
  2. Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea [ Time Frame: Baseline & Week 12 ]
  3. Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain [ Time Frame: Baseline & Week 12 ]

Secondary Outcome Measures :
  1. Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain [ Time Frame: Baseline & Week 24 ]
  2. Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea [ Time Frame: Baseline & Week 24 ]
  3. Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain [ Time Frame: Baseline & Week 24 ]
  4. Change from baseline to the end of treatment (EoT) of the dyspareunia score [ Time Frame: Baseline, Week 12 & Week 24 ]
  5. 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 ]
  6. 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 ]
  7. Change from baseline to the EoT of the use of protocol defined rescue medication [ Time Frame: Baseline, Week 12 & Week 24 ]
  8. Change from baseline to the EoT of the mean Pain Interference score of the Brief Pain Inventory [ Time Frame: Baseline, Week 12 & Week 24 ]
  9. Patient Global Impression of Change (PGIC) at the End of Treatment [ Time Frame: Week 12 & Week 24 ]
  10. Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score [ Time Frame: Baseline, Week 12 & Week 24 ]
  11. Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being) [ Time Frame: Baseline, Week 12 & Week 24 ]
  12. Change from baseline to the EoT of the Beck's Depression Inventory (BDI)-II score [ Time Frame: Baseline, Week 12 & Week 24 ]
  13. Change from baseline to the EoT in the EuroQol (EQ-5D-5L) score [ Time Frame: Baseline, Week 12 & Week 24 ]
  14. Safety and tolerability of ASP1707 measured by Adverse Events (AEs), bleeding patterns, Bone Mineral Density (BMD) [ Time Frame: Up to Week 42 ]
  15. Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels [ Time Frame: Up to Week 26 ]
  16. Pharmacokinetic profile of ASP1707 [ Time Frame: Up to Week 24 ]
    Both CL/F, V/F, AUCtau, Cmax, Ctrough



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767090


Locations
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Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
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Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01767090    
Other Study ID Numbers: 1707-CL-0011
2012-002791-14 ( EudraCT Number )
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Phase 2
Double-blind
Pelvic pain
ASP1707
Placebo-controlled
Endometriosis
Additional relevant MeSH terms:
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Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents