Single-dose secnidazole demonstrated comparable efficacy to 7-day BID metronidazole regimen2
Secnidazole vs. Metronidazole for the Treatment of BV
(clinical cure at day 28[%])2*†
* A multicenter, double-blind, double-dummy randomized phase-III study comparing secnidazole and metronidazole.2
Clinical cure was defined as the normalization of the three Amsel criteria. 95% CI secnidazole-metronidazole [-0.098 ; 0.052].2
But as many as
of patients DO NOT complete their full 7-day course of metronidazole.3
Your patients may be at increased risk for:
  • Pelvic Inflammatory Disease (PID)4
  • Acquisition of STIs (gonorrhea, chlamydia, HPV and HSV)5
  • Acquisition or transmission of HIV6
of patients treated with SOLOSEC did not require any additional treatment for BV7
SOLOSEC demonstrated clinically and statistically significant efficacy in the treatment of BV.7,8
SOLOSEC: the only single-dose oral antibiotic for the treatment of BV1
2020 ACOG and 2021 CDC guidelines include single-dose SOLOSEC for the treatment of BV.10,11

Bacterial Vaginosis Study Design
  • This multi-center, prospective, randomized, comparative, double-blind, double-dummy, Phase-III, noninferiority study was designed to compare the efficacy of secnidazole versus metronidazole in patients with bacterial vaginosis.
  • Patients were randomized to metronidazole (reference treatment) or secnidazole (study treatment) in a 1:1 ratio. After randomization, patients received either a single 2 g dose of secnidazole or the reference treatment, that is, a seven-day course of 500 mg metronidazole twice daily.
  • The primary efficacy endpoint was the therapeutic success, that is, a composite of clinical and bacteriological cure, at day 28. Clinical cure was defined as the normalization of the three Amsel criteria and bacteriological cure was defined as a Nugent score ≤ 3.

SOLOSEC was superior to placebo in all primary and secondary endpoints.
Pivotal Study 1 Clinical Cure Rate*
p < 0.001
* Study design information below.
Study Overview:
  • Study 1 enrolled 215 nonpregnant female patients aged 19-54 years. 188 women were included in the modified intent to treat (mITT) group and were randomized to 1:1:1 to receive either secnidazole 1 g (N = 71), secnidazole 2 g (N = 72), or placebo (N = 72).
  • Reasons for exclusion from the mITT group included baseline STIs (n=13 women), Nugent score < 4 at start of study (n=14), and clinically significant baseline laboratory abnormality that led to a diagnosis of chronic myeloid leukemia (n=1). Patients missing ≥ 1 of the clinical assessments were considered non-responders/not cured.
Study Endpoints:
  • Efficacy was assessed at the test of cure (TOC) visit after 21-30 days in the mITT group, following initial treatment with a single dose of SOLOSEC.
  • The primary efficacy endpoint was clinical cure, defined as normal vaginal discharge, negative 10% KOH whiff test, and clue cells < 20% of total epithelial cells on microscopic examination at the TOC/EOS visit.
Safety Analysis
  • The safety and tolerability of secnidazole was also evaluated in all 215 patients who were treated with a single dose of the study drug. Secnidazole was well-tolerated. 19.4% of patients receiving 2 g secnidazole experienced an adverse event. All treatment-related, treatment-emergent adverse events were judged to be mild to moderate.

Study Overview:
  • Study 2 enrolled 189 nonpregnant female patients aged 18 – 54 years. Patients were randomized 2:1 to receive a single oral dose of secnidazole 2 g (N = 125) or matched placebo (N = 64).
  • Efficacy was assessed in the modified intent to treat (mITT) group at the interim visit after 7-14 days and at the test of cure (TOC) visit after 21-30 days, following initial treatment with a single dose of SOLOSEC.
  • The mITT group was the primary efficacy population. Patients were excluded from the mITT group if their Nugent score < 4 or if baseline laboratory tests revealed a positive infection for a separate sexually transmitted infection.
Study Endpoints:
  • The primary efficacy endpoint was the proportion of clinical outcome responders, defined as those with: (1) normal vaginal discharge; (2) negative 10% potassium hydroxide whiff test; and (3) < 20% clue cells of total epithelial cell count on microscopic examination of the vaginal wet mount, using saline at the test of cure/end of study visit (study days 21-30). In addition, based on FDA draft guidance issued in 2016, patients with baseline Nugent scores 7-10 were evaluated for clinical cure using the following clinical assessments on days 7-14: (1) resolution of the abnormal vaginal discharge; (2) negative KOH whiff test; and (3) clue cells < 20%. The investigator's clinical opinion regarding whether the patient required additional BV treatment was documented at the TOC visit.
  • Single-dose secnidazole was superior to placebo for all primary and secondary endoints in the mITT population. Significantly more patients receiving SOLOSEC required no additional BV treatment (68.0% [68/100] vs. 29.6% [16/54]; p < .001).
Safety Analysis
  • The safety and tolerability of secnidazole was also evaluated in all 189 patients who were treated with a single dose of the study drug. 34% of patients receiving 2 g secnidazole experienced an adverse event (AE). Most AEs were mild or moderate in intensity and nonserious, and none led to study discontinuation.
1. SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2021. 2. Bohbot JM, Vicaut E, Fagnen D, Brauman M. Treatment of bacterial vaginosis: a multi-center, double-dummy, randomized phase III study comparing secnidazole and metronidazole. Infect Dis Obstet Gynecol 2010;2010:1-6. 3. Bartley JB, Ferris DG, Allmond LM, Dickman ED, Dias JK, Lambert J. Personal digital assistants used to document compliance of bacterial vaginosis treatment. Sex Transm Dis 2004;31(8):488-491.23. 4. Ness RB, Kip KE, Hillier SL et al. A Cluster Analysis of Bacterial Vaginosis-Associated Microflora and Pelvic Inflammatory Disease. Am J Epidemiol 2005;162(6):585-590. 5. Chavoustie SE, Maribona AS, Hanna M. Bacterial Vaginosis and the Risk for Sexually Transmitted Infections. Contemp Ob Gyn 2020. Educational Supplement. 6. Thurman AR, Kimble t, Herold B et al. Bacterial Vaginosis and Subclinical Markers of Genital Tract Inflammation and Mucosal Immunity. Aids Res Hum Retrovir 2015;31(11):1139-1152. 7. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol 2017;130(2):379-386. 8. Schwebke JR, Morgan FG Jr, Koltun W, Nyirjesy P. A phase-3, double-blind, placebo-controlled study of the effectiveness and safety of single oral doses of secnidazole 2 g for the treatment of women with bacterial vaginosis [published correction appears in Am J Obstet Gynecol 2018;219(1):110]. Am J Obstet Gynecol 2017;217(6):678.e1-678.e9. 9. Bradshaw CS, Morton AN, Hocking J, et al. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis 2006; 193:1478–89. 10. Workowski KA, Bachmann LH, Chan PA, et al. CDC Sexually Transmitted Diseases Treatment Guidelines, 2021. MMWR Recomm Rep 2021;70(RR-04):1-192. 11. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetricians-Gynecologists, Number 215. Obstet Gynecol 2020:135(1):e1-e17.