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

October 21, 2024 updated by: Astellas Pharma Europe B.V.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
912

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Site: 1006
      • Genk, Belgium, 3600
        • Site: 1002
      • Gent, Belgium, 9000
        • Site: 1003
      • Leuven, Belgium, 3000
        • Site: 1001
      • Liege, Belgium, 4000
        • Site: 1005
  • Bulgaria
      • Plovdiv, Bulgaria
        • Site: 1105
      • Sofia, Bulgaria, 1000
        • Site: 1104
      • Sofia, Bulgaria, 1330
        • Site: 1107
      • Sofia, Bulgaria, 1504
        • Site: 1106
      • Sofia, Bulgaria
        • Site: 1102
      • Stara Zagora, Bulgaria, 6000
        • Site: 1103
  • Germany
      • Berlin, Germany
        • Site: 1390
      • Dresden, Germany
        • Site: 1304
      • Erlangen, Germany
        • Site: 1302
      • Karlsruhe, Germany
        • Site: 1311
      • Luebeck, Germany
        • Site: 1306
  • Hungary
      • Budapest, Hungary, 1135
        • Site: 1401
      • Budapest, Hungary
        • Site: 1407
      • Debrecen, Hungary, 4012
        • Site: 1408
      • Pecs, Hungary
        • Site: 1406
      • Szekesfehervar, Hungary
        • Site: 1402
      • Szekszard, Hungary, 7100
        • Site: 1403
    • Bacs-Kiskun Megye
      • Kecskemet, Bacs-Kiskun Megye, Hungary, 6000
        • Site: 1422
  • Japan
      • Aomori, Japan, 036 8203
        • Site: 2018
      • Chiba, Japan, 299 0111
        • Site: 2017
      • Fujisawa, Japan, 252 0804
        • Site: 2005
      • Hyogo, Japan, 666 0195
        • Site: 2034
      • Hyogo, Japan
        • Site: 2039
      • Hyogo, Japan
        • Site: 2040
      • Kagoshima, Japan
        • Site: 2032
      • Kanagawa, Japan, 213 8507
        • Site: 2015
      • Kanagawa, Japan
        • Site: 2035
      • Kawagoe, Japan, 350-8550
        • Site: 2013
      • Kawasaki, Japan, 210 0024
        • Site: 2029
      • Kawasaki, Japan, 212 0058
        • Site: 2024
      • Kochi, Japan, 783 8505
        • Site: 2033
      • Kumamoto, Japan, 861 8520
        • Site: 2031
      • Kurashiki, Japan, 710 0824
        • Site: 2010
      • Kyoto, Japan, 602 8566
        • Site: 2006
      • Nagano, Japan
        • Site: 2036
      • Nagano, Japan
        • Site: 2037
      • Nagano, Japan
        • Site: 2038
      • Nagaoka, Japan, 940 2085
        • Site: 2002
      • Nagasaki, Japan, 850 0003
        • Site: 2007
      • Nara, Japan, 631 0805
        • Site: 2011
      • Sapporo, Japan, 060 0001
        • Site: 2027
      • Sapporo, Japan, 060 0031
        • Site: 2001
      • Sapporo, Japan, 060 0061
        • Site: 2030
      • Tokyo, Japan, 101 0062
        • Site: 2004
      • Tokyo, Japan, 107 0052
        • Site: 2020
      • Tokyo, Japan, 113 8431
        • Site: 2014
      • Tokyo, Japan, 113 8603
        • Site: 2009
      • Tokyo, Japan, 1130033
        • Site: 2003
      • Tokyo, Japan, 141 0022
        • Site: 2028
      • Tokyo, Japan, 157 0061
        • Site: 2025
      • Tokyo, Japan
        • Site: 2016
      • Yokohama, Japan, 225 0024
        • Site: 2012
  • Poland
      • Bialystok, Poland, 15-464
        • Site: 1501
      • Bialystok, Poland
        • Site: 1505
      • Gdansk, Poland
        • Site: 1512
      • Katowice, Poland, 40-724
        • Site: 1504
      • Lublin, Poland, 20-333
        • Site: 1508
      • Lublin, Poland, 20-632
        • Site: 1507
      • Warsaw, Poland
        • Site: 1509
      • Warszawa, Poland, 02-066
        • Site: 1502
      • Warzawa, Poland
        • Site: 1525
  • Romania
      • Brasov, Romania
        • Site: 1604
      • Bucaresti, Romania
        • Site: 1607
      • Bucharest, Romania, 11475
        • Site: 1602
      • Bucuresti, Romania
        • Site: 1601
      • Bucuresti, Romania
        • Site: 1606
      • Targu Mures, Romania
        • Site: 1603
  • Ukraine
      • Bucuresti, Ukraine
        • Site: 1701
      • Bucuresti, Ukraine
        • Site: 1702
      • Bucuresti, Ukraine
        • Site: 1705
      • Bucuresti, Ukraine
        • Site: 1707
      • Donetsk, Ukraine
        • Site: 1713
      • Donetsk, Ukraine
        • Site: 1716
      • Kyiv, Ukraine
        • Site: 1708
      • Targu Mures, Ukraine
        • Site: 1703
      • Zaporizhzhya, Ukraine
        • Site: 1717
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Site: 1807
      • Norwich, United Kingdom, NR47UY
        • Site: 1804
      • Sheffield, United Kingdom, S10 2SF
        • Site: 1808
      • Southampton, United Kingdom, SO16 5YA
        • Site: 1806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Prostap® SR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain
Time Frame: Baseline & Week 12
Baseline & Week 12
Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea
Time Frame: Baseline & Week 12
Baseline & Week 12
Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain
Time Frame: Baseline & Week 12
Baseline & Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain
Time Frame: Baseline & Week 24
Baseline & Week 24
Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea
Time Frame: Baseline & Week 24
Baseline & Week 24
Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain
Time Frame: Baseline & Week 24
Baseline & Week 24
Change from baseline to the end of treatment (EoT) of the dyspareunia score
Time Frame: Baseline, Week 12 & Week 24
Baseline, Week 12 & Week 24
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
Week 12 & Week 24
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
Baseline, Week 12 & Week 24
Change from baseline to the EoT of the use of protocol defined rescue medication
Time Frame: Baseline, Week 12 & Week 24
Baseline, Week 12 & Week 24
Change from baseline to the EoT of the mean Pain Interference score of the Brief Pain Inventory
Time Frame: Baseline, Week 12 & Week 24
Baseline, Week 12 & Week 24
Patient Global Impression of Change (PGIC) at the End of Treatment
Time Frame: Week 12 & Week 24
Week 12 & Week 24
Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score
Time Frame: Baseline, Week 12 & Week 24
Baseline, Week 12 & Week 24
Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being)
Time Frame: Baseline, Week 12 & Week 24
Baseline, Week 12 & Week 24
Change from baseline to the EoT of the Beck's Depression Inventory (BDI)-II score
Time Frame: Baseline, Week 12 & Week 24
Baseline, Week 12 & Week 24
Change from baseline to the EoT in the EuroQol (EQ-5D-5L) score
Time Frame: Baseline, Week 12 & Week 24
Baseline, Week 12 & Week 24
Safety and tolerability of ASP1707 measured by Adverse Events (AEs), bleeding patterns, Bone Mineral Density (BMD)
Time Frame: Up to Week 42
Up to Week 42
Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels
Time Frame: Up to Week 26
Up to Week 26
Pharmacokinetic profile of ASP1707
Time Frame: Up to Week 24
Both CL/F, V/F, AUCtau, Cmax, Ctrough
Up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Europe B.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Clinical Study Manager, Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1707-CL-0011
  • 2012-002791-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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