EndometriosisPhase 2NCT01767090
A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain
A Phase 2 study testing ASP1707 and Leuprorelin acetate in people with Endometriosis, run by Astellas Pharma Europe B.V. at 85 sites in 9 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- ASP1707 and Leuprorelin acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 912 participants
- Where
- 85 sitesin 9 countries
- Study dates
- 4 Dec 2012to 30 Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre menopausal female adults with confirmed length and regular menstrual cycle
- Surgically diagnosed endometriosis
- Moderate to severe endometriosis related pain
Who cannot join
- 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
Show all 9Show fewer
- Relevant abnormalities at gynecological exam at screening
- Disease with chronic abdominal pain of non-endometriosis origin
- Pituitary adenoma
Trial locations and contacts
85 sites in 9 countries.
85 sites in 9 countries
Japan34 sites
Site: 2018
Aomori, 036 8203
Site: 2017
Chiba, 299 0111
Site: 2005
Fujisawa, 252 0804
Site: 2034
Hyōgo, 666 0195
Site: 2039
Hyōgo
Site: 2040
Hyōgo
Site: 2032
Kagoshima
Site: 2015
Kanagawa, 213 8507
Site: 2035
Kanagawa
Site: 2013
Kawagoe, 350-8550
Site: 2029
Kawasaki, 210 0024
Site: 2024
Kawasaki, 212 0058
Site: 2033
Kochi, 783 8505
Site: 2031
Kumamoto, 861 8520
Site: 2010
Kurashiki, 710 0824
Site: 2006
Kyoto, 602 8566
Site: 2036
Nagano
Site: 2037
Nagano
Site: 2038
Nagano
Site: 2002
Nagaoka, 940 2085
Site: 2007
Nagasaki, 850 0003
Site: 2011
Nara, 631 0805
Site: 2027
Sapporo, 060 0001
Site: 2001
Sapporo, 060 0031
Site: 2030
Sapporo, 060 0061
Site: 2004
Tokyo, 101 0062
Site: 2020
Tokyo, 107 0052
Site: 2014
Tokyo, 113 8431
Site: 2009
Tokyo, 113 8603
Site: 2003
Tokyo, 1130033
Site: 2028
Tokyo, 141 0022
Site: 2025
Tokyo, 157 0061
Site: 2016
Tokyo
Site: 2012
Yokohama, 225 0024
Poland9 sites
Site: 1501
Bialystok, 15-464
Site: 1505
Bialystok
Site: 1512
Gdansk
Site: 1504
Katowice, 40-724
Site: 1508
Lublin, 20-333
Site: 1507
Lublin, 20-632
Site: 1502
Warsaw, 02-066
Site: 1509
Warsaw
Site: 1525
Warzawa
Ukraine9 sites
Site: 1701
Bucuresti
Site: 1702
Bucuresti
Site: 1705
Bucuresti
Site: 1707
Bucuresti
Site: 1713
Donetsk
Site: 1716
Donetsk
Site: 1708
Kyiv
Site: 1703
Targu Mures
Site: 1717
Zaporizhzhya
Hungary7 sites
Site: 1401
Budapest, 1135
Site: 1407
Budapest
Site: 1408
Debrecen, 4012
Site: 1422
Kecskemét, Bacs-Kiskun Megye, 6000
Site: 1406
Pécs
Site: 1402
Székesfehérvár
Site: 1403
Szekszárd, 7100
Bulgaria6 sites
Site: 1105
Plovdiv
Site: 1104
Sofia, 1000
Site: 1107
Sofia, 1330
Site: 1106
Sofia, 1504
Site: 1102
Sofia
Site: 1103
Stara Zagora, 6000
Romania6 sites
Site: 1604
Brasov
Site: 1607
Bucaresti
Site: 1602
Bucharest, 11475
Site: 1601
Bucharest
Site: 1606
Bucharest
Site: 1603
Târgu Mureş
Belgium5 sites
Site: 1006
Brussels, 1200
Site: 1002
Genk, 3600
Site: 1003
Ghent, 9000
Site: 1001
Leuven, 3000
Site: 1005
Liège, 4000
Germany5 sites
Site: 1390
Berlin
Site: 1304
Dresden
Site: 1302
Erlangen
Site: 1311
Karlsruhe
Site: 1306
Lübeck
United Kingdom4 sites
Site: 1807
London, SE5 9RS
Site: 1804
Norwich, NR47UY
Site: 1808
Sheffield, S10 2SF
Site: 1806
Southampton, SO16 5YA
About this study
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
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.
- Conditions
- Endometriosis
- Being tested
- ASP1707, Placebo, Leuprorelin acetate
- Keywords
- Phase 2, Double-blind, Pelvic pain, ASP1707, Placebo-controlled, Endometriosis
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1707Drug
Oral
PlaceboDrug
Oral
Leuprorelin acetateDrug
Also called Prostap® SR
subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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) Receives: Drug: Placebo |
| ASP1707 lowest dose | Experimental | 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 Receives: Drug: ASP1707 |
| ASP1707 low dose | Experimental | 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 Receives: Drug: ASP1707 |
| ASP1707 medium dose | Experimental | 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 Receives: Drug: ASP1707 |
| ASP1707 high dose | Experimental | 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 Receives: Drug: ASP1707 |
| Leuprorelin acetate | Active comparator | Subjects in this arm will be treated with leuprorelin acetate for a total of 24 weeks Receives: Drug: Leuprorelin acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain
Measured: Baseline & Week 12
Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea
Measured: Baseline & Week 12
Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain
Measured: Baseline & Week 12
Secondary outcomes (16)
Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain
Measured: Baseline & Week 24
Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea
Measured: Baseline & Week 24
Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain
Measured: Baseline & Week 24
Change from baseline to the end of treatment (EoT) of the dyspareunia score
Measured: 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
Measured: 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
Measured: Baseline, Week 12 & Week 24
Change from baseline to the EoT of the use of protocol defined rescue medication
Measured: Baseline, Week 12 & Week 24
Change from baseline to the EoT of the mean Pain Interference score of the Brief Pain Inventory
Measured: Baseline, Week 12 & Week 24
Patient Global Impression of Change (PGIC) at the End of Treatment
Measured: Week 12 & Week 24
Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score
Measured: Baseline, Week 12 & Week 24
Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being)
Measured: Baseline, Week 12 & Week 24
Change from baseline to the EoT of the Beck's Depression Inventory (BDI)-II score
Measured: Baseline, Week 12 & Week 24
Change from baseline to the EoT in the EuroQol (EQ-5D-5L) score
Measured: Baseline, Week 12 & Week 24
Safety and tolerability of ASP1707 measured by Adverse Events (AEs), bleeding patterns, Bone Mineral Density (BMD)
Measured: Up to Week 42
Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels
Measured: Up to Week 26
Pharmacokinetic profile of ASP1707
Both CL/F, V/F, AUCtau, Cmax, Ctrough
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study start4 Dec 2012
- Primary completion13 May 2015
- Study completion30 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767090
- Sponsor's protocol ID
- 1707-CL-0011
- Other IDs
- 2012-002791-14
- Status last verified
- Oct 2024
- First submitted
- 18 Dec 2012
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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/.
Publications
D'Hooghe T, Fukaya T, Osuga Y, Besuyen R, Lopez B, Holtkamp GM, Miyazaki K, Skillern L. Efficacy and safety of ASP1707 for endometriosis-associated pelvic pain: the phase II randomized controlled TERRA study. Hum Reprod. 2019 May 1;34(5):813-823. doi: 10.1093/humrep/dez028.
PubMed 31067329
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01767090
- Acronym / sponsor ID
- 1707-CL-0011
- Conditions
- Endometriosis
- Keywords
- Phase 2, Double-blind, Pelvic pain, ASP1707, Placebo-controlled, Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 912 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2012 (actual)
- Primary completion
- 13 May 2015 (actual)
- Study completion
- 30 Jul 2015 (actual)
- First posted
- 14 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboApplicable 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) |
| ASP1707 lowest dose | Experimental | Drug: ASP1707Subjects 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 |
| ASP1707 low dose | Experimental | Drug: ASP1707Subjects 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 |
| ASP1707 medium dose | Experimental | Drug: ASP1707Subjects 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 |
| ASP1707 high dose | Experimental | Drug: ASP1707Subjects 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 |
| Leuprorelin acetate | Active comparator | Drug: Leuprorelin acetateSubjects in this arm will be treated with leuprorelin acetate for a total of 24 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pre menopausal female adults with confirmed length and regular menstrual cycle
- Surgically diagnosed endometriosis
- Moderate to severe endometriosis related pain
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP1707Oral | Drug | ASP1707 high dose, ASP1707 low dose, ASP1707 lowest dose, ASP1707 medium dose |
| PlaceboOral | Drug | Placebo |
| Leuprorelin acetateAlso: Prostap® SRsubcutaneous | Drug | Leuprorelin acetate |
Primary outcome
Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain
Time frame: Baseline & Week 12
Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea
Time frame: 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
16 secondary outcomes
Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain
Time frame: Baseline & Week 24
Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea
Time frame: 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
Change from baseline to the end of treatment (EoT) of the dyspareunia score
Time frame: 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
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
Change from baseline to the EoT of the use of protocol defined rescue medication
Time frame: 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
Patient Global Impression of Change (PGIC) at the End of Treatment
Time frame: 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
Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being)
Time frame: 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
Change from baseline to the EoT in the EuroQol (EQ-5D-5L) score
Time frame: 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
Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels
Time frame: Up to Week 26
Pharmacokinetic profile of ASP1707
Time frame: Up to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 31067329D'Hooghe T, Fukaya T, Osuga Y, Besuyen R, Lopez B, Holtkamp GM, Miyazaki K, Skillern L. Efficacy and safety of ASP1707 for endometriosis-associated pelvic pain: the phase II randomized controlled TERRA study. Hum Reprod. 2019 May 1;34(5):813-823. doi: 10.1093/humrep/dez028.
- Individual participant dataSharing planned: Yes. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
85 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP1707 and Leuprorelin acetate in people with Endometriosis, run by Astellas Pharma Europe B.V. at 85 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in Japan, Poland, Ukraine, Hungary, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain (time frame: Baseline & Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01767090, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.