Trial · NCT04553068

Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection

NCT04553068, Phase 3, Completed, Evofem Inc.; results first posted 2024-01-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection. Trials, record NCT04553068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04553068

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
NCT number: NCT04553068
Status: Completed
Phases: Phase 3
Enrollment: 1,892 participants, actual
Lead sponsor: Evofem Inc.
Conditions: Sexually Transmitted Diseases, Gonorrhea, Chlamydia
Interventions: EVO100, Placebo
First posted: 2020-09-17
Last updated: 2024-01-30
Results first posted: 2024-01-30

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Study Successes in the EVO100 and Placebo Treatment Groups	16 weeks	Percentage of subjects who are defined study successes among the intervention groups with success defined as subjects completing the trial to Visit 5 without any CT or GC infection and no usage of prohibited antibiotics during the study.
Secondary	Evaluate Safety of EVO100: AEs	16 weeks	Descriptive analysis of AEs

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Study Successes in the EVO100 and Placebo Treatment Groups	16 weeks	mITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Evaluate Safety of EVO100: AEs	16 weeks	Safety	participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Percentage of Study Successes in the EVO100 and Placebo Treatment Groups	EVO100 Gel		684	Participants
Percentage of Study Successes in the EVO100 and Placebo Treatment Groups	Placebo Gel		696	Participants
Evaluate Safety of EVO100: AEs	EVO100 Gel	Serious TEAEs	4	participants
Evaluate Safety of EVO100: AEs	Placebo Gel	Serious TEAEs	9	participants
Evaluate Safety of EVO100: AEs	EVO100 Gel	SAEs	2	participants
Evaluate Safety of EVO100: AEs	Placebo Gel	SAEs	2	participants
Evaluate Safety of EVO100: AEs	EVO100 Gel	Treatment related AEs	81	participants
Evaluate Safety of EVO100: AEs	Placebo Gel	Treatment related AEs	62	participants
Evaluate Safety of EVO100: AEs	EVO100 Gel	Deaths	0	participants
Evaluate Safety of EVO100: AEs	Placebo Gel	Deaths	0	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	EVO100 Gel	943
Overall Study	STARTED	Placebo Gel	949
Overall Study	COMPLETED	EVO100 Gel	792
Overall Study	COMPLETED	Placebo Gel	805
Overall Study	NOT COMPLETED	EVO100 Gel	151
Overall Study	NOT COMPLETED	Placebo Gel	144

Source ClinicalTrials.gov

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	vaginal discharge	Reproductive system and breast disorders	EVO100 Gel	39	926	39
other	vaginal discharge	Reproductive system and breast disorders	Placebo Gel	28	937	28
serious	ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	EVO100 Gel	2	926	2
serious	ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	Placebo Gel	0	937	0
serious	blood loss anemia	Blood and lymphatic system disorders	EVO100 Gel	1	926	1
serious	blood loss anemia	Blood and lymphatic system disorders	Placebo Gel	0	937	0
serious	alcohol poisoning	Nervous system disorders	EVO100 Gel	1	926	1
serious	alcohol poisoning	Nervous system disorders	Placebo Gel	0	937	0
serious	craniocerebral injury	Injury, poisoning and procedural complications	EVO100 Gel	1	926	1
serious	craniocerebral injury	Injury, poisoning and procedural complications	Placebo Gel	0	937	0

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	EVO100 Gel	0	926
Total, all-cause mortality	Placebo Gel	0	937
Total, other adverse events	EVO100 Gel	39	926
Total, other adverse events	Placebo Gel	28	937
Total, serious adverse events	EVO100 Gel	4	926
Total, serious adverse events	Placebo Gel	9	937

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35418329	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
EVO100 Gel vs Placebo Gel: deaths from any cause	Trial comparisons
EVO100 Gel vs Placebo Gel: Percentage of Study Successes in the EVO100 and Placebo Treatment Groups	Trial comparisons
EVO100 Gel vs Placebo Gel: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04553068

GET https://conductscience.org/api/trials/v1/NCT04553068/events?page=2

API reference For AI assistants