CompletedPhase 3

Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule

Turkey (Türkiye)577 participantsStarted 2020-07-20

Plain-language summary

Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.

Who can participate

Age range18 Years – 55 Years

SexFEMALE

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Inclusion criteria

✓. Female patients with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (at least 10 times a year)
✓. Female patients who previously experienced vaginal intercourse
✓. Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis or mixed infections according to the investigator's decision
✓. Signed informed consent

Exclusion criteria

✕. Known hypersensitivity to active ingredients (including their derivatives) of the study medications
✕. Vaginismus, endometriosis, dyspareunia
✕. Detection of urinary tract infection in urinalysis
✕. Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors and ongoing organ failure
✕. Usage of herbal medicines and drugs that interfere with microsomal enzymes, especially cytochrome P450 (phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, topiramate, felbamate, griseofulvin, HIV protease inhibitors such as ritonavir, nucleoside reverse transcriptase inhibitors such as efavirenz)
✕. History of cardiovascular event
✕. Uncontrolled diabetes and hypertension
✕. Presence or known risk or of venous or arterial thromboembolism

What they're measuring

Percentage of patients who had complete response to treatment according to clinical findings

Timeframe: 13 days (+/- 5 days) after treatment

Trial details

NCT IDNCT06056947

SponsorEge University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-06

View on ClinicalTrials.gov More Trichomonal Vaginitis trials