Etonogestrel
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | IMPLANON | — | 2011-05-13 – 2026-01-16 | fda.gov ↗ |
| Approved | US (FDA) | NUVARING | — | 2001-10-03 | fda.gov ↗ |
Trials 45
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT06775626 | Apr 2025 | menstrual disorder | Maíta Poli de Araújo | Suspended | No outcome recorded |
| Phase 0 | NCT04423068 | Dec 2020 → Apr 2022 | pregnancy disorder | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT05174884 | Dec 2023 → Jun 2027 expected | — | FHI 360 | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05994599 | Jul → Dec 2023 | — | Evestra Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03656289 | Jan → Apr 2019 | — | University of Colorado, Denver | Withdrawn | No outcome recorded |
| Phase 1 | NCT01813162 | Dec 2013 → Dec 2014 | — | CONRAD | Completed | No outcome recorded |
| Phase 28 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT07201402 | May 2026 → May 2029 expected | — | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT05360550 | Jul 2022 → Jan 2023 | — | Lupin Research Inc | Completed | No outcome recorded |
| Phase 2 | NCT05227456 | Jul 2022 → Apr 2024 | dysmenorrhea | Saskatchewan Health Authority - Regina Area | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03282799 | Feb 2019 → Dec 2020 | HIV infectious disease | Catherine Anne Chappell | Completed | Met primary |
| Phase 2 | NCT03589040 | Sep 2018 → Jun 2019 | HIV infectious disease | Makerere University | Unknown | No outcome recorded |
| Phase 2 | NCT01670656 | Jan → Sep 2013 | dysmenorrhea | Organon and Co | Completed | Met primary |
| Phase 2 | NCT01709318 | Dec 2012 → Oct 2013 | — | Organon and Co | Completed | Missed primary |
| Phase 2 | NCT00967746 | Nov 2009 → Nov 2010 | — | Organon and Co | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05791799 | Apr 2023 → Oct 2025 | systemic lupus erythematosus | Sixth Affiliated Hospital, Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2/3 | NCT02669238 | May 2018 → Oct 2019 | endometriosis | Centre Hospitalier Universitaire de la Réunion | Terminated | No outcome recorded Stop: Enrollment |
| Phase 38 trials | ||||||
| Phase 3 | NCT04626596 | Nov 2020 → Dec 2024 | — | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT02866643 | Oct 2016 → Sep 2019 | — | Stanford University | Completed | No outcome recorded |
| Phase 3 | NCT02668783 | Feb → Sep 2016 | primary dysmenorrhea | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02668822 | Feb → Sep 2016 | primary dysmenorrhea | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02616146 | Dec 2015 → Oct 2016 | — | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02524288 | Aug 2015 → Sep 2016 | — | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03585504 | Jan 2010 → Jan 2013 | — | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 3 | NCT00620035 | Mar 2007 → Oct 2010 | — | Organon and Co | Completed | No outcome recorded |
| Phase 418 trials | ||||||
| Phase 4 | NCT05237141 | Apr 2022 → Dec 2026 expected | — | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 4 | NCT04669678 | Nov 2021 → Feb 2024 | HIV infectious disease | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT04463693 | Oct 2020 → Feb 2022 | — | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT04423055 | Aug 2020 → Apr 2024 | — | University of California, Davis | Completed | No outcome recorded |
| Phase 4 | NCT03978598 | Jun 2019 → Jun 2024 | — | University of New Mexico | Completed | No outcome recorded |
| Phase 4 | NCT03353012 | Jan → May 2018 | puerperal disorder | Chulalongkorn University | Completed | No outcome recorded |
| Phase 4 | NCT02852265 | Sep 2016 → Jul 2017 | — | University of California, Davis | Completed | No outcome recorded |
| Phase 4 | NCT02469454 | Jun 2015 → Aug 2016 | — | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT02367846 | Jan 2015 → Dec 2028 expected | bone development disease | Penn State University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02367833 | Jan 2015 → Dec 2017 | bone disorder | Penn State University | Completed | No outcome recorded |
| Phase 4 | NCT02594462 | Jan 2015 → Oct 2018 | sickle cell disease | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT01767285 | Jan 2013 → Apr 2015 | — | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT01666912 | Aug 2012 → Apr 2015 | puerperal disorder | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT01638767 | Jul 2012 → Jul 2014 | infertility disorder | Clinique Ovo | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01490190 | Dec 2011 → Dec 2012 | — | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT01299116 | Dec 2011 → Jun 2016 | — | FHI 360 | Completed | No outcome recorded |
| Phase 4 | NCT01448291 | Oct 2011 → Oct 2012 | bacterial vaginosis | Eastern Virginia Medical School | Unknown | No outcome recorded |
| Phase 4 | NCT00725413 | Nov 2001 → Nov 2005 | — | Organon and Co | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT05044962 | Nov 2021 → Mar 2027 expected | HIV infectious disease | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| — | NCT02529683 | Apr 2014 → Aug 2015 | — | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| — | NCT00828542 | Jul 2007 → Feb 2008 | — | University of Sao Paulo | Completed | No outcome recorded |
| Comparator or background therapy19 trials | ||||||
| Phase 0 | NCT05760144 Comparator | Jul 2023 → Nov 2026 expected | — | Oregon Health and Science University | Recruiting | No outcome recorded |
| Phase 2 | NCT00651807 Comparator | Mar → Aug 2008 | benign prostatic hyperplasia | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT00403793 Comparator | Oct 2003 → Dec 2006 | — | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT05156658 Comparator | Jan → Aug 2024 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Withdrawn | No outcome recorded |
| Phase 4 | NCT06162611 Comparator | Nov 2023 → Apr 2028 expected | — | Lori Gawron | Recruiting | No outcome recorded |
| Phase 4 | NCT05730205 Comparator | Aug 2023 → Mar 2027 expected | sickle cell disease | University of Pennsylvania | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04814927 Comparator | Mar 2021 → Dec 2022 | mucositis | Eastern Virginia Medical School | Completed | No outcome recorded |
| Phase 4 | NCT03307863 Comparator | Nov 2017 → Nov 2027 | — | University of Sao Paulo | Suspended | No outcome recorded |
| Phase 4 | NCT02480647 Comparator | May 2016 → Aug 2017 | endometriosis | University of Campinas, Brazil | Completed | No outcome recorded |
| Phase 4 | NCT02735551 Comparator | Apr 2016 → Mar 2017 | — | Oregon Health and Science University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02082652 Comparator | Oct 2014 → Mar 2016 | HIV infectious disease | University of Pittsburgh | Completed | No outcome recorded |
| Phase 4 | NCT01588873 Comparator | Apr 2012 → Dec 2018 | — | University of Oulu | Unknown | No outcome recorded |
| Phase 4 | NCT01438736 Background | Sep 2011 → Nov 2012 | hemorrhagic disease | VL-Medi Oy | Unknown | No outcome recorded |
| Phase 4 | NCT00847587 Comparator | Jan → Dec 2009 | lactation disease | University of Utah | Completed | No outcome recorded |
| Phase 4 | NCT01044056 Comparator | Mar → Jun 2004 | — | Organon and Co | Completed | No outcome recorded |
| — | NCT05174195 Background | Aug 2016 → Mar 2018 | progestogen hypersensitivity | University Hospital, Geneva | Terminated | Missed primary Stop: Enrollment |
| — | NCT02144259 Comparator | Apr 2011 → Oct 2012 | — | University of Pennsylvania | Completed | No outcome recorded |
| — | NCT01087879 Comparator | Oct 2007 → Jan 2011 | — | University of Oulu | Completed | No outcome recorded |
| — | NCT00612508 Comparator | May 2007 → May 2008 | — | Oregon Health and Science University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-01-16 | Organon and Co | Regulatory Organon Announces US Food and Drug Administration Approval of Supplemental New Drug Application Extending Duration of Use of NEXPLANON® (etonogestrel implant) 68 mg Radiopaque organon.com ↗
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON® (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. |
All press releases naming this drug 5 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 69 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Etonogestrel | “The purpose of this study is to assess the contraceptive efficacy of the Etonogestrel (ENG) + 17β-Estradiol (E2) vaginal ring in women between 18 and 35 years of age based on...” NCT02524288 ↗62“The used preparations are: Vaginal ring, depotproduct: ethinylestradiol 2.7 mg (0,015 mg/day) and etonogestrel 11.7 mg (0,120 mg/day)and the contraceptive pill,...” NCT01588873 ↗ “A Study to Evaluate the Effect of a Contraceptive Vaginal Ring LSP- 5415 Releasing Ethinyl Estradiol Plus Etonogestrel on Ovarian Function in Healthy Adult Females” NCT05360550 ↗ “Participants in the CVR group (NuvaRing - 15µg/d EE/120µg/d etonogestrel) will insert a vaginal ring into the vagina on Day 1 of the intervention.” NCT02367833 ↗ “etogestrel/ ethinyl estradiol slow release vaginal ring (11.4 mg/2.6 mg) to deliver 120 mcg etonogestrel/15 mcg ethinyl estradiol per day” NCT01638767 ↗ “Dose: per ring 11.7 mg etonogestrel and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.” NCT01044056 ↗ “Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)” NCT01299116 ↗ “The IVR contains two active components, etonogestrel (progestin) and ethinyl estradiol (estrogen).” NCT01813162 ↗ “EVE119 (ethinyl estradiol/etonogestrel) vaginal ring delivering 0.015 mg/0.12 mg dose per day” NCT05994599 ↗ “etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands)” NCT02469454 ↗ “the etonogestrel implant may be an optimal method of contraception for women with SCD.” NCT05730205 ↗ |
| Known as | 3-keto desogestrel | “Etonogestrel implant is a single implant progestogen-only, with 4 cm in length and 2 mm diameter containing 68 mg etonogestrel (3- ketodesogestrel), the active metabolite of desogestrel” NCT02594462 ↗1“containing etonogestrel (ETG, 3-keto desogestrel).” NCT04669678 ↗ |
| Known as | ENG | “The purpose of this study is to assess the contraceptive efficacy of the Etonogestrel (ENG) + 17β-Estradiol (E2) vaginal ring in women between 18 and 35 years of age based on...” NCT02524288 ↗10“To evaluate the effect of investigational vaginal rings containing nomegestrol acetate (NOMAC) plus 17β-estradiol (E2) or etonogestrel (ENG) plus E2 in women with moderate to...” PMID 30439359 ↗ Nov 2018 “The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA...” NCT00620035 ↗ “a new combination of an etonogestrel (ENG) implant combined with testosterone undecanoate (TU) injections for male contraception.” PMID 18413423 ↗ Apr 2008 “The primary purpose of this study is to assess the efficacy and safety of the etonogestrel (ENG) contraceptive implant” NCT04626596 ↗ “etonogestrel (ENG) + 17β-estradiol (E2) (MK-8342B) vaginal ring” NCT02668822 ↗ “Etonogestrel (ENG) Subdermal Implants” NCT05156658 ↗ “etonogestrel (ENG) implant” NCT03307863 ↗ “22.2 mg Etonogestrel (ENG)” NCT05174884 ↗ “etonogestrel (ENG) implant” PMID 40488538 ↗ Jun 2025 “Etonogestrel (ENG)” NCT01709318 ↗ |
| Known as | ENG-IMPLANT | “etonogestrel-releasing contraceptive implant (ENG-IMPLANT)” PMID 36915205 ↗ Mar 2023 |
| Known as | ETG | “The effects of etonogestrel (ETG)-releasing contraceptive implant during the immediate postpartum period on maternal safety are unknown.” PMID 19913145 ↗ Jul 2009 |
| Known as | etogestrel | “etogestrel/ ethinyl estradiol slow release vaginal ring (11.4 mg/2.6 mg) to deliver 120 mcg etonogestrel/15 mcg ethinyl estradiol per day” NCT01638767 ↗ |
| Known as | Implanon | “The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ETG, 3-keto desogestrel).” NCT04669678 ↗3“Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)” NCT01299116 ↗ “Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon” NCT02735551 ↗ “etonogestrel implant (Implanon)” NCT00725413 ↗ |
| Known as | Implanon NXT | “The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ETG, 3-keto desogestrel).” NCT04669678 ↗1“Changes in Body Composition and Sport Performance Among Young Female Soccer Players Using Subdermic Etonogestrel (Implanon NXT)” NCT06775626 ↗ |
| Known as | Implanon, Etonogestrel implant | “Implanon, Etonogestrel implant” NCT00828542 ↗ |
| Known as | Nexplanon | “Nexplanon, a radiopaque etonogestrel implant in combination with a
next-generation applicator: 3-year results of a noncomparative multicenter
trial.” PMID 22939402 ↗ Aug 20125“The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ETG, 3-keto desogestrel).” NCT04669678 ↗ “The etonogestrel contraceptive implant (Nexplanon®) remains the most effective hormonal contraceptive method available in the U.S.” NCT04463693 ↗ “Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)” NCT01438736 ↗ “contraceptive implant (Etonogestrel implant also called Nexplanon)” NCT05760144 ↗ “Etonogestrel 68mg subcutaneous implant (Nexplanon)” NCT04423068 ↗ |
| Route | Subcutaneous | “low- or high-release ENG implant sc” PMID 18413423 ↗ Apr 2008 |