Trichomonas InfectionPhase 3NCT03935217
A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
A Phase 3 study testing Secnidazole in people with Trichomonas Infection, run by Lupin Research Inc at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Trichomonas Infection
- What is being tested?
- Secnidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 11 sitesUnited States
- Study dates
- 23 Apr 2019to 25 Mar 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Site 1007
Birmingham, Alabama, 35294
Site 1008
Chapel Hill, North Carolina, 27599
Site 1011
Charleston, South Carolina, 29425
Site 1014
Chicago, Illinois, 60605
Site 1004
Fayetteville, North Carolina, 28304
Site 1013
Jackson, Mississippi, 39216
Site 1009
Lawrenceville, New Jersey, 08648
Site 1001
Memphis, Tennessee, 38104
Site 1002
Memphis, Tennessee, 38120
Site 1003
North Miami, Florida, 33161
Site 1006
Virginia Beach, Virginia, 23456
About this study
Official title: Multi-center, Prospective, Randomized, Placebo-Controlled, Delayed Treatment, Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of Solosec® for the Treatment of Trichomoniasis
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.
Read the detailed description
The study will consist of a primary study phase (Visit 1 (baseline) to Visit 2 (Day 6-12)) and a follow-up phase (Visit 2 to Visit 3 (7-12 days post Visit 2)). During the primary phase patients will be randomly assigned in a 1:1 ratio to either Solosec or placebo. Patients will return to the clinic for the "test of cure" (TOC) visit to be conducted on Days 6-12 (Visit 2).
To ensure all patients receive treatment and to maintain the double-blind, after completion of the primary phase, patients will receive the opposite treatment , (placebo patients will receive Solosec and vice versa). Patients with V2 cultures that are subsequently positive for T. vaginalis will return to the clinic for Visit 3 (V3) assessments and investigator assessment of need for additional therapy (an additional Visit 4 may be scheduled at the investigator's discretion if culture at V3 is positive).
Summary of results includes data reported during the primary phase of the study [Visit 1 (baseline) to Visit 2/TOC (Day 6-12)]
- Conditions
- Trichomonas Infection
- Being tested
- Secnidazole, Placebo
- Keywords
- Vaginal Itching, Vaginal Discharge
- Medical subject headings
- Trichomonas Infections, Vaginal Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecnidazoleDrug
Also called Solosec®
Oral Granules containing secnidazole
PlaceboDrug
Oral Granules of placebo manufactured to mimic secnidazole
| Study group | Role | What they receive |
|---|---|---|
| Solosec (containing 2 grams of secnidazole) | Experimental | Orally administered as a single dose with applesauce. Receives: Drug: Secnidazole |
| Placebo | Placebo comparator | Orally administered as a single dose with applesauce. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological Cure at the TOC Visit
Vaginal Culture negative for T. vaginalis at TOC Visit
Measured: Study Day 6-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start23 Apr 2019
- Primary completion2 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trichomonas InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For primary phase of study, patients were randomly assigned in a 1:1 ratio to either Solosec or Placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lupin Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jackie Shaw, Study director, Director, Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935217
- Sponsor's protocol ID
- SEC-WH-301
- Status last verified
- Sep 2023
- First submitted
- 30 Apr 2019
- Last updated
- 4 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
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.
PubMed 37550019Muzny 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.
PubMed 33768237
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Randomized, Placebo-Controlled, Delayed Treatment, Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of Solosec® for the Treatment of Trichomoniasis
- ClinicalTrials.gov ID
- NCT03935217
- Acronym / sponsor ID
- SEC-WH-301
- Conditions
- Trichomonas Infection
- Keywords
- Vaginal Itching, Vaginal Discharge
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Lupin Research IncIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 4 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will consist of a primary study phase (Visit 1 (baseline) to Visit 2 (Day 6-12)) and a follow-up phase (Visit 2 to Visit 3 (7-12 days post Visit 2)). During the primary phase patients will be randomly assigned in a 1:1 ratio to either Solosec or placebo. Patients will return to the clinic for the "test of cure" (TOC) visit to be conducted on Days 6-12 (Visit 2).
To ensure all patients receive treatment and to maintain the double-blind, after completion of the primary phase, patients will receive the opposite treatment , (placebo patients will receive Solosec and vice versa). Patients with V2 cultures that are subsequently positive for T. vaginalis will return to the clinic for Visit 3 (V3) assessments and investigator assessment of need for additional therapy (an additional Visit 4 may be scheduled at the investigator's discretion if culture at V3 is positive).
Summary of results includes data reported during the primary phase of the study [Visit 1 (baseline) to Visit 2/TOC (Day 6-12)]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- For primary phase of study, patients were randomly assigned in a 1:1 ratio to either Solosec or Placebo.
| Arm | Type | Receives |
|---|---|---|
| Solosec (containing 2 grams of secnidazole) | Experimental | Drug: SecnidazoleOrally administered as a single dose with applesauce. |
| Placebo | Placebo comparator | Drug: PlaceboOrally administered as a single dose with applesauce. |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecnidazoleAlso: Solosec®Oral Granules containing secnidazole | Drug | Solosec (containing 2 grams of secnidazole) |
| PlaceboOral Granules of placebo manufactured to mimic secnidazole | Drug | Placebo |
Primary outcome
Microbiological Cure at the TOC Visit
Time frame: Study Day 6-12
Vaginal Culture negative for T. vaginalis at TOC Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37550019Muzny 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.
- Derived from this study: PubMed 33768237Muzny 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
Related trials for Trichomonas Infection
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STI Testing to Enhance PrEP Use in Pregnancy
PrEP Adherence, Sexually Transmitted Infections (STIs)
RecruitingPhase 4
Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
Trichomonas Vaginitis, Bacterial Vaginitis
Active, not recruiting
Point-of-care Tests for Vaginal Discharge in Nepal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie Shaw study director
Director, Clinical Operations
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secnidazole in people with Trichomonas Infection, run by Lupin Research Inc at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological Cure at the TOC Visit (time frame: Study Day 6-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935217, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.