A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
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ClinicalTrials.gov Identifier: NCT03935217 |
Recruitment Status :
Completed
First Posted : May 2, 2019
Last Update Posted : April 21, 2020
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Condition or disease | Intervention/treatment | Phase |
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Trichomonas Infection | Drug: Secnidazole Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 147 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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® Granules Containing 2 Grams of Secnidazole for the Treatment of Trichomoniasis |
Actual Study Start Date : | April 23, 2019 |
Actual Primary Completion Date : | March 18, 2020 |
Actual Study Completion Date : | March 18, 2020 |

Arm | Intervention/treatment |
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Experimental: Solosec (containing 2 grams of secnidazole)
Orally administered as a single dose with applesauce. Upon completion of primary phase patients will receive the opposite treatment (placebo)
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Drug: Secnidazole
Oral Granules containing secnidazole
Other Name: Solosec® Drug: Placebo Oral Granules of placebo manufactured to mimic secnidazole |
Placebo Comparator: Placebo
Orally administered as a single dose with applesauce. Upon completion of primary phase patients will receive the opposite treatment (Solosec (containing 2 grams of secnidazole)
|
Drug: Secnidazole
Oral Granules containing secnidazole
Other Name: Solosec® Drug: Placebo Oral Granules of placebo manufactured to mimic secnidazole |
- Microbiological Cure [ Time Frame: Study Day 6-12 ]Vaginal Culture negative for T. vaginalis at TOC Visit
- Outcome Responders [ Time Frame: Study Day 6-12 ]Complete resolution of trichomoniasis symptoms (i.e. itching, discharge and odor recorded as normal) and vaginal culture result negative for T. vaginalis at TOC Visit

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Must be female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult female or post-menarche adolescent girl ≥12 years of age in general good health
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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
Exclusion Criteria:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935217
United States, Alabama | |
Site 1007 | |
Birmingham, Alabama, United States, 35294 | |
United States, Florida | |
Site 1003 | |
North Miami, Florida, United States, 33161 | |
United States, Illinois | |
Site 1014 | |
Chicago, Illinois, United States, 60605 | |
United States, Mississippi | |
Site 1013 | |
Jackson, Mississippi, United States, 39216 | |
United States, New Jersey | |
Site 1009 | |
Lawrenceville, New Jersey, United States, 08648 | |
United States, North Carolina | |
Site 1008 | |
Chapel Hill, North Carolina, United States, 27599 | |
Site 1004 | |
Fayetteville, North Carolina, United States, 28304 | |
United States, South Carolina | |
Site 1011 | |
Charleston, South Carolina, United States, 29425 | |
United States, Tennessee | |
Site 1001 | |
Memphis, Tennessee, United States, 38104 | |
Site 1002 | |
Memphis, Tennessee, United States, 38120 | |
United States, Virginia | |
Site 1006 | |
Virginia Beach, Virginia, United States, 23456 |
Study Director: | Jackie Shaw | Director, Clinical Operations |
Responsible Party: | Lupin Research Inc |
ClinicalTrials.gov Identifier: | NCT03935217 |
Other Study ID Numbers: |
SEC-WH-301 |
First Posted: | May 2, 2019 Key Record Dates |
Last Update Posted: | April 21, 2020 |
Last Verified: | April 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Vaginal Itching Vaginal Discharge |
Trichomonas Infections Protozoan Infections Parasitic Diseases Secnidazole |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |