Drugs / Decapeptyl

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) TRELSTAR 2000-06-15 fda.gov

Trials 12 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02908438 Sep 2016 → Sep 2017 Northwest Women's and Children's Hospital, Xi'an, Shaanxi Unknown No outcome recorded
Phase 22 trials
Phase 2 NCT05557604 Feb 2021 → Feb 2024 overdue prostate cancer Regina Elena Cancer Institute Recruiting No outcome recorded
Phase 2 NCT00194792 Aug 2005 → Jul 2011 Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, progesterone-receptor positive breast cancer University of Washington Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04356664 Mar 2021 → Jun 2026 overdue adenomyosis, endometriosis, female infertility Hopital Foch Recruiting No outcome recorded
Phase 33 trials
Phase 3 NCT06525155 Jan 2024 → Feb 2025 overdue endometriosis Rumah Sakit Pusat Angkatan Darat Gatot Soebroto Recruiting No outcome recorded
Phase 3 NCT05019846 Sep 2021 → Dec 2025 overdue prostate cancer Marco Lorenzo Bonu Recruiting No outcome recorded
Phase 3 NCT02862782 Sep 2016 → Sep 2019 Tel-Aviv Sourasky Medical Center Unknown No outcome recorded
Phase 42 trials
Phase 4 NCT02048891 Oct 2014 → Jan 2015 infertility disorder Rambam Health Care Campus Completed No outcome recorded
Phase 4 NCT02749825 Sep 2002 → May 2006 prostate cancer Pharmatech Terminated No outcome recorded
Phase not applicable3 trials
NCT03660813 Jul 2018 → Aug 2021 Sheba Medical Center Completed No outcome recorded
NCT02827656 Aug 2016 → Aug 2017 infertility disorder Meir Medical Center Unknown No outcome recorded
NCT02368964 Feb 2015 → Jun 2020 infertility disorder Sheba Medical Center Completed No outcome recorded
Also used as a comparator or background therapy in 24 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT03332797 Background Nov 2017 → Jul 2027 expected breast cancer Genentech, Inc. Active not recruiting No outcome recorded
Phase 28 trials
Phase 2 NCT07142551 Background Mar 2026 → Jun 2030 expected castration-resistant prostate carcinoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting No outcome recorded
Phase 2 NCT06922318 Background Aug 2025 → Aug 2031 expected castration-resistant prostate carcinoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting No outcome recorded
Phase 2 NCT06059118 Background Oct 2023 → Jan 2027 expected prostate cancer Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting No outcome recorded
Phase 2 NCT03809000 Background Apr 2019 → Apr 2023 overdue prostate cancer RTOG Foundation, Inc. Active not recruiting No outcome recorded
Phase 2 NCT03311555 Background Mar 2018 → Dec 2022 prostate cancer Andrew J. Armstrong, MD Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06282588 Background Dec 2023 → Jul 2030 expected prostate cancer Cancer Research Antwerp Recruiting No outcome recorded
Phase 34 trials
Phase 3 NCT04961996 Background Aug 2021 → Aug 2025 overdue breast cancer Hoffmann-La Roche Active not recruiting No outcome recorded
Phase 3 NCT04537078 Comparator Sep 2020 → Mar 2021 female infertility El Shatby University Hospital for Obstetrics and Gynecology Completed No outcome recorded
Phase 3 NCT04064840 Comparator Sep 2019 → Sep 2024 overdue infertility disorder The University of Hong Kong Recruiting No outcome recorded
Phase 3 NCT02342197 Comparator Jan → Dec 2011 infertility disorder Kasr El Aini Hospital Completed No outcome recorded
Phase 41 trial
Phase 4 NCT01888744 Comparator Sep 2010 → Jun 2013 infertility disorder University Hospital Brussels Completed No outcome recorded
Phase not applicable9 trials
NCT06739759 Comparator Nov 2024 → Jun 2025 overdue ovarian hyperstimulation syndrome Aljazeera Hospital Recruiting No outcome recorded
NCT05838105 Comparator Oct 2022 → Jan 2025 Shaare Zedek Medical Center Unknown No outcome recorded
NCT04749979 Comparator Feb → Jun 2021 infertility disorder Aljazeera Hospital Unknown No outcome recorded
NCT02737800 Comparator Apr 2016 → Aug 2017 ovarian endometriosis Kasr El Aini Hospital Completed No outcome recorded
NCT02346253 Background Jan 2015 → Dec 2021 prostate adenocarcinoma Stanford University Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2019-06-12 Ipsen Debiopharm and Ipsen extend their strategic Decapeptyl® (triptorelin) partnership for another 15 years ipsen.com

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 36 sources stand behind the page.

FieldValueCited text
Known as Decapeptyl “GnRHa group receive three injections of GnRHa(Decapeptyl) ,0.1 mg s.c. on the day of ET, and D3 and D6 after ET in addition to routine LPS.” NCT02908438
21

“ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.” NCT02048891

“daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle” NCT01389713

“Single intramuscular 0.1 mg decapeptyl are given on day of transfer” NCT01790282

“One or two intramuscular injections of Decapeptyl 3 mg” NCT04356664

“Day 3 after ET - Ovitrelle 125mcg + Decapeptyl 0.1mg” NCT05838105

“antagonist protocol with triggering by DecapeptylNCT06739759

“0.1 decapeptyl from day 21 in the previous cycle” NCT02429999

“GnRH agonist - Decapeptyl , hCG - Ovitrelle” NCT02368964

Decapeptyl® 0,1 mg subcutaneously daily” NCT01888744

NCT02144818

NCT06282588

NCT04064840

NCT03660813

NCT04749979

NCT02862782

NCT02342197

NCT02827656

NCT00542126

NCT04537078

NCT02737800

NCT05557604

Known as Trelstar “Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix...” NCT03311555
6

“Patients will continue on ADT with LHRH agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix) if not surgically castrated throughout...” NCT06922318

“Choice of LHRHa per investigator discretion/site practice guidelines (e.g, Eligard®, Zoladex®, Lupron Depot®, Trelstar®) and ARN-509 Tablets, 240 mg/day administered orally” NCT01790126

“luteinizing hormone-releasing hormone (LHRH) agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix)” NCT06059118

Trelstar®” NCT03809000

NCT02749825

NCT07142551

Known as Triptorelin Embonate ClinicalTrials.gov intervention name — accepted as the source's own label NCT06525155
1

NCT05019846

Known as triptorelin pamoate “Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix...” NCT03311555
5

“The LHRH agonist (leuprolide acetate, goserelin acetate, or triptorelin pamoate) will be administered by injection once every 4 weeks on Day 1 of each 28-day cycle, according...” NCT03332797

“LHRH agonists may include, but are not limited to, leuprolide acetate, goserelin acetate, or triptorelin pamoate.” NCT04961996

NCT00194792

NCT02168062

NCT02346253

Action Inhibit “to inhibit endogenous testosterone production” NCT06922318
Route Intramuscular “triptorelin pamoate intramuscularly (IM)” NCT00194792