NCT03935217

Brief Summary

This is a Phase 3, multi-center, prospective, randomized, placebo-controlled, delayed treatment, double-blind, study to evaluate the effectiveness, and safety of a single, oral dose of Solosec® containing 2 grams of secnidazole in female patients with trichomoniasis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2020

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

October 4, 2023

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

April 30, 2019

Results QC Date

October 27, 2021

Last Update Submit

October 2, 2023

Conditions

Trichomonas Infection

Keywords

Vaginal ItchingVaginal Discharge

Outcome Measures

Primary Outcomes (1)

  • Microbiological Cure at the TOC Visit

    Vaginal Culture negative for T. vaginalis at TOC Visit

    Study Day 6-12

Study Arms (2)

Solosec (containing 2 grams of secnidazole)

EXPERIMENTAL

Orally administered as a single dose with applesauce.

Drug: Secnidazole

Placebo

PLACEBO COMPARATOR

Orally administered as a single dose with applesauce.

Drug: Placebo

Interventions

SecnidazoleDRUG

Oral Granules containing secnidazole

Also known as: Solosec®
Solosec (containing 2 grams of secnidazole)
PlaceboDRUG

Oral Granules of placebo manufactured to mimic secnidazole

Placebo

Eligibility Criteria

Age12 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMust be female
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adult female or post-menarche adolescent girl ≥12 years of age in general good health
  • Have a diagnosis of trichomoniasis at the screening visit as determined by one of the following:
  • positive T. vaginalis NAAT test within 30 days of screening for which treatment has not been initiated.
  • positive OSOM® rapid test.
  • positive wet mount assessment.
  • Agree to abstain from vaginal intercourse until the final study visit
  • Agree not to have any vaginal penetration or use of any vaginal products for the duration of the study

You may not qualify if:

  • Are pregnant, lactating, or planning to become pregnant during the study.
  • Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including symptomatic vulvovaginal candidiasis, chlamydia, gonorrhea, or an active genital herpes outbreak
  • Are suspected clinically of having an acute urinary tract infection.
  • Have active genital lesions, including primary syphilitic chancres and herpes simplex virus lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator (patients with genital warts may be enrolled).
  • Have received systemic antibacterial therapy or topical antimicrobial/antifungal/ immunomodulatory therapies in the genital area (vagina, vulva and surrounding soft tissue), within 14 days prior to the Baseline Visit (Day 1).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Site 1007

Birmingham, Alabama, 35294, United States

Location

Site 1003

North Miami, Florida, 33161, United States

Location

Site 1014

Chicago, Illinois, 60605, United States

Location

Site 1013

Jackson, Mississippi, 39216, United States

Location

Site 1009

Lawrenceville, New Jersey, 08648, United States

Location

Site 1008

Chapel Hill, North Carolina, 27599, United States

Location

Site 1004

Fayetteville, North Carolina, 28304, United States

Location

Site 1011

Charleston, South Carolina, 29425, United States

Location

Site 1001

Memphis, Tennessee, 38104, United States

Location

Site 1002

Memphis, Tennessee, 38120, United States

Location

Site 1006

Virginia Beach, Virginia, 23456, United States

Location

Related Publications (2)

  • Muzny CA, Van Gerwen OT, Kaufman G, Chavoustie S. Efficacy of single-dose oral secnidazole for the treatment of trichomoniasis in women co-infected with trichomoniasis and bacterial vaginosis: a post hoc subgroup analysis of phase 3 clinical trial data. BMJ Open. 2023 Aug 7;13(8):e072071. doi: 10.1136/bmjopen-2023-072071.

    PMID: 37550019DERIVED

  • Muzny CA, Schwebke JR, Nyirjesy P, Kaufman G, Mena LA, Lazenby GB, Van Gerwen OT, Graves KJ, Arbuckle J, Carter BA, McMahon CP, Eder S, Shaw J, Pandey B, Chavoustie SE. Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study. Clin Infect Dis. 2021 Sep 15;73(6):e1282-e1289. doi: 10.1093/cid/ciab242.

    PMID: 33768237DERIVED

MeSH Terms

Conditions

Trichomonas InfectionsVaginal Discharge

Interventions

secnidazole

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title
Director of Clinical Operations
Organization
Lupin Pharmaceuticals
jackieshaw@lupin.com
443-301-3146

Study Officials

  • Jackie Shaw

    Director, Clinical Operations

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: For primary phase of study, patients were randomly assigned in a 1:1 ratio to either Solosec or Placebo.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 2, 2019

Study Start

April 23, 2019

Primary Completion

March 2, 2020

Study Completion

March 25, 2020

Last Updated

October 4, 2023

Results First Posted

October 4, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of the primary study results, the research team will prepare final research data files that may be shared with other investigators, upon request.
Access Criteria
Requests for research data must be submitted to author CAM in writing, via a standard data request form, with a justification for how the data will be used. Author CAM and Lupin Pharmaceuticals will review all requests for research data obtained from this study. The mechanism by which the data will be made available to investigators will follow all NIH guidelines for data sharing as they evolve. At a minimum this would consist of a data use agreement that provides for commitments to use the data for research purposes only, secure the data with appropriate computer technology, obtain IRB approval, and destroy (or return) the data after analyses are complete.

Locations

US(11)