Drugs / EVO100
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT04553068 | Oct 2020 → Jul 2022 | chlamydia trachomatis infectious disease, gonorrhea | Evofem Inc. | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT03107377 Comparator | Nov 2017 → Aug 2019 | chlamydia trachomatis infectious disease | Evofem Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2022-10-11 | Evofem Inc. | Results Evofem Reports Top-Line Results from Phase 3 EVOGUARD Clinical Trial Evaluating EVO100 for Prevention of Chlamydia and Gonorrhea Infection in Women evofem.com ↗
Evofem Biosciences, Inc. (OTCQB: EVFM) announced today that the recently completed Phase 3 EVOGUARD clinical trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women did not achieve its endpoints. |
| 2022-06-02 | Evofem Inc. | Regulatory US Food and Drug Administration Extends Phexxi® Shelf Life to Four Years evofem.com ↗
Evofem Biosciences, Inc. ( Nasdaq: EVFM ) (Evofem) today announced that the U.S. Food and Drug Administration (FDA) has formally extended the shelf life of Phexxi ® (lactic acid, citric acid, potassium bitartrate) from three to four years. |
| 2022-03-31 | Evofem Inc. | Results Evofem Presents Positive Encore Data in Sexually Transmitted Infections Impacting Women at the 2022 Academy of Managed Care Pharmacy Annual Meeting evofem.com ↗
Positive AMPREVENCE Data Serve as the Foundation for the Ongoing, Confirmatory and Registrational Phase 3 EVOGUARD Trial Investigating EVO100 to Prevent Chlamydia and Gonorrhea in Women |
| 2022-02-09 | Evofem Inc. | Regulatory FDA Awards QIDP Designation for Prevention of Chlamydia to Evofem Biosciences evofem.com ↗ |
| 2021-05-17 | Evofem Inc. | Results New Data on EVO100 for the Prevention of Chlamydia and Gonorrhea in Women to be Presented at ISPOR 2021 evofem.com ↗
Participants reported that adherence with use of EVO100 was related to product satisfaction and the impact on global sexual satisfaction as well as efficacy. |
| 2021-05-12 | Evofem Inc. | Regulatory Evofem Biosciences Receives Fast Track Designation for EVO100 for Prevention of Gonorrhea in Women evofem.com ↗
Evofem Biosciences, Inc., (NASDAQ: EVFM) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EVO100 for the prevention of urogenital gonorrhea in women. |
| 2021-03-16 | Evofem Inc. | Results Evofem Biosciences Announces Publication in American Journal of Obstetrics and Gynecology of AMPREVENCE Study of EVO100 for Chlamydia and Gonorrhea Prevention evofem.com ↗
This double-blinded, placebo-controlled, multicenter study of EVO100 met its primary and secondary efficacy endpoints with statistically significant reductions in the risk of chlamydia and gonorrhea infections in women at high risk of infection. |
| 2020-09-14 | Evofem Inc. | Results Evofem Biosciences to Present Data at the 2020 STD Prevention Virtual Conference from Phase 2b Trial of EVO100 for Prevention of Chlamydia and Gonorrhea in Women evofem.com ↗
The Phase 2b study met its primary and secondary endpoints, with women receiving EVO100 experiencing a relative risk reduction for chlamydia and gonorrhea infection of 50% and 78%, respectively, compared to women receiving placebo. |
All press releases naming this drug 12 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EVO100 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04553068 ↗ |
| Known as | Amphora Gel | “EVO100 (previously known as Amphora ® Gel)” NCT03107377 ↗ |
| Modality | Other / unclassified | “EVO100 is an investigational antimicrobial, pH-modulating, vaginal gel” PMID 33705748 ↗ Mar 2021 |
| Route | Other | “5 g intravaginally applied at least one hour prior to vaginal intercourse” NCT03107377 ↗ |