Trial · NCT03935217

A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis

NCT03935217, Phase 3, Completed, Lupin Research Inc; results first posted 2023-10-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis. Trials, record NCT03935217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03935217

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Trial

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

Title: A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
NCT number: NCT03935217
Status: Completed
Phases: Phase 3
Enrollment: 147 participants, actual
Lead sponsor: Lupin Research Inc
Conditions: Trichomonas Infection
Interventions: Secnidazole, Placebo
First posted: 2019-05-02
Last updated: 2023-10-04
Results first posted: 2023-10-04

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Microbiological Cure at the TOC Visit	Study Day 6-12	Vaginal Culture negative for T. vaginalis at TOC Visit

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Microbiological Cure at the TOC Visit	Study Day 6-12	Modified Intent to Treat Population (Patients with culture positive for T. vaginalis at baseline)	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Microbiological Cure at the TOC Visit	Solosec 2 Grams		59		Participants
Microbiological Cure at the TOC Visit	Placebo		1		Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Solosec 2 Grams	74
Overall Study	STARTED	Placebo	73
Overall Study	COMPLETED	Solosec 2 Grams	73
Overall Study	COMPLETED	Placebo	70
Overall Study	NOT COMPLETED	Solosec 2 Grams	1
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events12

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	Nausea	Gastrointestinal disorders	Solosec (Containing 2 Grams of Secnidazole)	2	74	2
other	Nausea	Gastrointestinal disorders	Placebo	3	73	3
other	Diarrhea	Gastrointestinal disorders	Solosec (Containing 2 Grams of Secnidazole)	1	74	1
other	Diarrhea	Gastrointestinal disorders	Placebo	2	73	2
other	Vulvovagnial candidiasis	Infections and infestations	Solosec (Containing 2 Grams of Secnidazole)	2	74	2
other	Vulvovagnial candidiasis	Infections and infestations	Placebo	0	73	0
other	Trichomoniasis	Infections and infestations	Solosec (Containing 2 Grams of Secnidazole)	0	74	0
other	Trichomoniasis	Infections and infestations	Placebo	2	73	2
other	Headache	Nervous system disorders	Solosec (Containing 2 Grams of Secnidazole)	1	74	1
other	Headache	Nervous system disorders	Placebo	5	73	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Solosec (Containing 2 Grams of Secnidazole)	0	74
Total, all-cause mortality	Placebo	0	73
Total, other adverse events	Solosec (Containing 2 Grams of Secnidazole)	6	74
Total, other adverse events	Placebo	14	73
Total, serious adverse events	Solosec (Containing 2 Grams of Secnidazole)	0	74
Total, serious adverse events	Placebo	0	73

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33768237	DERIVED	PubMed
37550019	DERIVED	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
Solosec 2 Grams vs Placebo: Microbiological Cure at the TOC Visit	Trial comparisons
Solosec (Containing 2 Grams of Secnidazole) vs Placebo: deaths from any cause	Trial comparisons
Solosec (Containing 2 Grams of Secnidazole) vs Placebo: 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/NCT03935217

GET https://conductscience.org/api/trials/v1/NCT03935217/registered

API reference For AI assistants