Dienogest
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NATAZIA | — | 2010-05-06 | fda.gov ↗ |
Trials 44
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06719934 | Jan → Jun 2025 overdue | adenomyosis | Al-Azhar University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05332106 | Mar 2022 | — | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 1 | NCT04230083 | Dec 2019 | — | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 1 | NCT04193852 | Nov 2019 | — | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 1 | NCT03353857 | Nov 2017 → Jul 2018 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00754871 | Sep 2008 → Jul 2009 | — | Bayer | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT02728245 | Oct 2017 → Mar 2018 | ovarian endometriosis | Seoul National University Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT01283724 | Mar 2011 → Mar 2013 | endometriosis | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00471991 | Apr → Dec 2007 | — | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00318799 | Apr 2006 → May 2007 | — | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00185224 | Mar 2005 → Mar 2006 | — | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00805415 | Mar 2003 → Feb 2004 | anovulation | Bayer | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06115408 | Sep 2023 → Aug 2024 | uterine corpus leiomyoma | Ain Shams University | Completed | No outcome recorded |
| Phase 2/3 | NCT02599077 | Nov 2015 → Nov 2017 | endometriosis | Fundación Santa Fe de Bogota | Suspended | No outcome recorded |
| Phase 316 trials · 4 met primary · 1 missed | ||||||
| Phase 3 | NCT06145438 | Sep 2023 → Aug 2024 | ovarian endometriosis | Universitas Diponegoro | Completed | No outcome recorded |
| Phase 3 | NCT05697471 | Feb 2023 → Dec 2025 | endometriosis | Far Eastern Memorial Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03945513 | Dec 2019 → Jun 2023 | — | Insud Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01822080 | Mar 2013 → Apr 2015 | endometriosis | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01638910 | Jun 2012 → Nov 2014 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01638923 | Jun 2012 → Jun 2015 | hemometra | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00909857 | Apr 2009 → Nov 2010 | primary dysmenorrhea | Bayer | Completed | Missed primary |
| Phase 3 | NCT00764881 | Jan 2009 → Jul 2010 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00778609 | Dec 2008 → Dec 2010 | headache disorder, pelvis syndrome | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00754065 | Sep 2008 → May 2011 | — | Bayer | Completed | Met primary |
| Phase 3 | NCT00307801 | Feb 2006 → May 2008 | hemometra | Bayer | Completed | Met primary |
| Phase 3 | NCT00293059 | Dec 2005 → May 2008 | hemometra | Bayer | Completed | Met primary |
| Phase 3 | NCT00185367 | Mar 2005 → Sep 2006 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00206583 | Mar 2005 → Jun 2007 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00225186 | Jul 2004 → Mar 2008 | endometriosis | Bayer | Completed | Met primary |
| Phase 3 | NCT00280657 | Mar 2004 → May 2005 | acne | Bayer | Completed | No outcome recorded |
| Phase 411 trials · 1 missed | ||||||
| Phase 4 | NCT05937490 | Mar 2023 → Mar 2025 | adenomyosis | University Hospital of Modena | Unknown | No outcome recorded |
| Phase 4 | NCT06316206 | Jan → Aug 2023 | endometrial polyp | University of Palermo | Completed | No outcome recorded |
| Phase 4 | NCT06324851 | Jan → Aug 2023 | endometrial polyp | University of Palermo | Completed | No outcome recorded |
| Phase 4 | NCT03789123 | Jan → Jul 2019 | — | Bagcilar Training and Research Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03654144 | Nov 2018 → Dec 2019 | adenomyosis | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT02440750 | Jun 2016 → Apr 2017 | leiomyoma | University of Cagliari | Unknown | No outcome recorded |
| Phase 4 | NCT02352090 | Apr 2015 → Dec 2018 | — | Helsinki University Central Hospital | Completed | Missed primary |
| Phase 4 | NCT02385448 | Feb 2015 → Feb 2017 | endometriosis | The University of Hong Kong | Unknown | No outcome recorded |
| Phase 4 | NCT02575248 | Oct 2014 → Jul 2017 | female infertility | Ain Shams University | Unknown | No outcome recorded |
| Phase 4 | NCT01738724 | Jan 2012 → Dec 2016 | leiomyoma | University of Sao Paulo | Terminated | No outcome recorded |
| Phase 4 | NCT00335218 | Jul 2002 → Aug 2004 | premature menopause | Bayer | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06577974 | Jul 2024 → Feb 2025 overdue | endometriosis | Cairo University | Recruiting | No outcome recorded |
| — | NCT06396208 | May → Oct 2024 | anovulation | Chulalongkorn University | Completed | No outcome recorded |
| — | NCT03142035 | Oct 2017 → Feb 2023 | endometriosis | American University of Beirut Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 0 | NCT04374006 Comparator | Nov 2019 → May 2020 | endometriosis of pelvic peritoneum | Indonesia University | Completed | No outcome recorded |
| Phase 2 | NCT03172533 Comparator | Mar 2016 → Jan 2019 | anorexia nervosa | University of Erlangen-Nürnberg Medical School | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01221831 Comparator | Sep 2010 → Sep 2011 | — | Estetra | Completed | No outcome recorded |
| Phase 2/3 | NCT04256200 Comparator | Feb 2017 → Nov 2021 | endometriosis | American University of Beirut Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT07164183 Comparator | Sep 2025 → Oct 2026 expected | endometriosis | Alcea | Recruiting | No outcome recorded |
| Phase 3 | NCT02427334 Comparator | Apr 2015 → Dec 2021 | premenstrual tension | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT01697111 Comparator | Oct 2012 → Mar 2014 | endometriosis | Bayer | Completed | Met primary |
| Phase 3 | NCT00302666 Comparator | Jun 2003 → Feb 2005 | — | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT06543550 Comparator | Jul 2024 → Sep 2025 overdue | endometriosis | Bio Meds Pharmaceutica Ltda | Recruiting | No outcome recorded |
| Phase 4 | NCT03124524 Comparator | Jan 2015 → Sep 2016 | primary dysmenorrhea | Adana Numune Training and Research Hospital | Completed | No outcome recorded |
| — | NCT05476172 Comparator | Apr 2021 → May 2023 | endometriosis | Uludag University | Completed | No outcome recorded |
| — | NCT03890042 Comparator | Mar 2019 → Jul 2020 | adenomyosis | Assiut University | Completed | No outcome recorded |
| — | NCT04500743 Comparator | Aug 2018 → Oct 2019 | endometriosis | National Research Centre, Egypt | Completed | No outcome recorded |
| — | NCT02400801 Comparator | Jun 2013 → Dec 2017 | endometriosis, female infertility | Universitaire Ziekenhuizen KU Leuven | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2018-12-20 | Bayer | Regulatory Bayer receives approval in China for endometriosis treatment Visanne™ bayer.com ↗
Bayer announced today that Visanne™ has been approved by the Chinese regulatory authorities for the treatment of endometriosis. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2018-12-20 | Bayer | Bayer receives approval in China for endometriosis treatment Visanne™ bayer.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dienogest | “A Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled, Two-arm, Phase IV Study to Investigate the Influence of a Continuous Combined Estrogen-progestin...” NCT00335218 ↗57“Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2...” NCT01638910 ↗ “Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel.” PMID 21679006 ↗ 2011 “1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles” NCT00280657 ↗ “2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo.” NCT01638923 ↗ “Dienogest 2mg is given daily for 3 months then followed by Clomiphene citrate 5 mg induction of ovulation for three months” NCT02575248 ↗ “Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg” NCT00805415 ↗ “comprising estradiol valerate/dienogest (E2V/DNG; administered using a dynamic dosing regimen)” PMID 19835717 ↗ May 2009 “Group B: will receive Dienogest for 3-6 months prior to starting IVF / ICSI cycle.” NCT06577974 ↗ “All women received dienogest (2 mg once daily, orally) and changes in pelvic pain” PMID 21681516 ↗ Jun 2011 “Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen.” NCT00778609 ↗ |
| Known as | 81150037 | “Dienogest (81150037)” NCT00754871 ↗ |
| Known as | 81150231 | “Dienogest (81150231)” NCT00754871 ↗ |
| Known as | 81150746 | “Dienogest (81150746)” NCT00754871 ↗ |
| Known as | BAY86-5258 | “Dienogest (Visanne, BAY86-5258)” NCT01822080 ↗1“Dienogest (Visanne, BAY86-5258)” NCT01283724 ↗ |
| Known as | Dienogest (Visanne) | “Dienogest (Visanne)” NCT06577974 ↗ |
| Known as | Dienogest component of natazia | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201864 ↗ |
| Known as | DNG | “2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placeboA blister card consists of 28...” NCT00293059 ↗12“This study aimed to assess the efficacy of randomly started oral dienogest/ethinylestradiol (DNG/EE) for swift endometrial preparation prior to outpatient hysteroscopic...” PMID 39329272 ↗ Sep 2024 “We compared the effects of COCs containing ethinyl estradiol (EE) or estradiol valerate (EV) and dienogest (DNG) with those containing DNG only on inflammation and lipid metabolism.” PMID 32303765 ↗ Jul 2020 “2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo.” NCT01638923 ↗ “Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg” NCT00805415 ↗ “Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen.” NCT00764881 ↗ “Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen.” NCT00754065 ↗ “Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen.” NCT00778609 ↗ “Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral)” NCT00206583 ↗ “estradiol valerate/dienogest (E(2)V/DNG)” PMID 21721593 ↗ 2011 “2 mg dienogest (DNG) once daily by mouth” NCT01822080 ↗ |
| Known as | Endometrion | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201864 ↗ |
| Known as | M 18575 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201864 ↗ |
| Known as | MJR-35 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201864 ↗ |
| Known as | SH T00660A | “Dienogest (SH T00660A)” NCT00754871 ↗ |
| Known as | STS 557 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201864 ↗ |
| Known as | Visanne | “Group A: patients receive dienogest 2 mg (visanne 2mg sanofi Aventis) daily for three months then followed by induction of ovulation with clomiphene citrate” NCT02575248 ↗5“Group 1 will receive oral dienogest (visanne® Bayer, Germany) 2mg for 14 days starting from the 15th day of menstruation” NCT02427334 ↗ “Visanne (dienogest) 2 mg tablets orally once a day during 24 weeks” NCT07164183 ↗ “Dienogest (Visanne, BAY86-5258)” NCT01822080 ↗ “Dienogest (Visanne, BAY86-5258)” NCT01283724 ↗ “Dienogest/ Visanne” NCT03353857 ↗ |
| Known as | ZK 37659 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201864 ↗ |
| Action | Inhibit | “Within the available scientific evidence it has been extensively described the benefits of the new progestins Dienogest, demonstrating a favorable safety profile and efficacy...” NCT02599077 ↗ |
| Modality | Small molecule | — CHEMBL1201864 ↗ |
| Route | Oral | “novel oral contraceptive” PMID 21721593 ↗ 2011 |