9 completed. 4 Phase 3, 3 Phase 1, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Completed 4 |
| Phase 1 | 3 | Completed 3 |
| Phase 2 | 3 | Completed 3 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) Metronidazole oral tablets 500mg, 1% SPL7013 Gel, Placebo gel - Bacterial Vaginosis | Phase 3 | Completed | Starpharma Pty Ltd | 586 | 2014-10-13 | 2019-07-22 |
| Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) Metronidazole oral tablets 500mg, 1% SPL7013 Gel, Placebo gel - Bacterial Vaginosis | Phase 3 | Completed | Starpharma Pty Ltd | 637 | 2014-10-03 | 2018-06-25 |
| A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis 1% SPL7013 Gel, Placebo - Bacterial Vaginosis | Phase 3 | Completed | Starpharma Pty Ltd | 251 | 2012-04-17 | 2019-07-17 |
| A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis 1% SPL7013 Gel, Placebo - Bacterial Vaginosis | Phase 3 | Completed | Starpharma Pty Ltd | 250 | 2012-03-28 | 2019-07-17 |
| Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV) 1% SPL7013 Gel, 3% SPL7013 Gel, placebo gel - Recurrent Bacterial Vaginosis (BV) | Phase 2 | Completed | Starpharma Pty Ltd | 205 | 2011-08-01 | 2013-11-20 |
| Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV) 0.5% SPL7013 Gel, 1.0% SPL7013 Gel, 3.0% SPL7013 Gel - Bacterial Vaginosis | Phase 2 | Completed | Starpharma Pty Ltd | 132 | 2010-08-01 | 2019-06-06 |
| Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing. 3% SPL7013 Gel (VivaGel) - HIV Infections, HSV-2 Genital Herpes | Phase 1 / Phase 2 | Completed | Starpharma Pty Ltd | 12 | 2008-08-01 | 2018-10-30 |
| Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women 3% SPL7013 Gel (VivaGel), Placebo Gel, HEC Placebo Gel - Healthy | Phase 1 | Completed | Starpharma Pty Ltd | 61 | 2007-07-01 | 2010-06-24 |
| SPL7013 Gel - Male Tolerance Study 3% w/w SPL7013 Gel (VivaGel™) - Human Immunodeficiency Virus (HIV) | Phase 1 | Completed | Starpharma Pty Ltd | 36 | 2006-08-01 | 2008-01-16 |
Vaginosis, Bacterial (6) · Acquired Immunodeficiency Syndrome (1) · HIV Infections (1) · Recurrence (1)
astodrimer (7) · Metronidazole (2)
United States (4) · Australia (2) · Puerto Rico (2) · Bulgaria (1) · Canada (1) · Czechia (1) · Hungary (1) · Ukraine (1) · United Kingdom (1)
Jeremy Paull, PhD (3) · Jeremy Paull, PhD. (2) · Anne Macek, MD (1) · Ian McGowan, MD, PhD (1) · Marcus Chen, MD, PhD (1)