Leucorex Vaginal Cream

Adjuvant therapy for vaginal infections caused by Candida and Gardnerella species

The antibacterial and antifungal activities of thymol are well-known. These activities seem to be due to piercing cell membrane and rapid expulsion of intracellular organelles. Furthermore, the phenolic compounds of thyme (thymol and carvacrol) exert their antibacterial effect by complex formation with bacterial cell membrane.

 Thymol and carvacrol are responsible for thyme’s antiseptic properties. A synergistic effect for the combination of thymol and carvacrol has also been documented. Among a spectrum of tested compounds, a free hydroxyl group in connection to an alkyl unit exerts the antifungal properties.

In a controlled, randomized, double-blind clinical trial, 62 patients with candidal vaginitis applied one applicator per night of either Leucorex Vaginal Cream (containing Iranian thyme essential oil) or clotrimazole vaginal cream for one week.  Based in the results of this survey, in comparison with clotrimazole vaginal cream, Leucorex Vaginal Cream had a more significant effect upon the symptoms of the disease (p<0.05). Also, Leucorex Vaginal Cream showed better effects on the gynecologic symptoms compared to clotrimazole vaginal cream. According to the physicians contributing to the study, no significant difference regarding the efficacy of the two drugs was observed (p=0.071). Furthermore, in neither of the two groups, no significant adverse reaction was reported.

In another controlled, randomized, double-blind clinical trial, 61 patients with gardneralla vaginitis either applied one applicator per night of Leucorex Vaginal Cream or took 2 metronidazole tablets orally every 12 hours for one week. The results of this study showed that both medications reduced disease symptoms including the unpleasant fishy odor, homogenous discharges, erythema, vulvar and vaginal inflammation and clue cells (p=0.000). In all cases, the percentage of clinical response was better in case of Leucorex Vaginal Cream; it also reduced erythema and  vulvar and vaginal inflammation more significantly, compared to metronidazole tablet (p=0.02).

Also, in a clinical trial, 90 married women aging 18-40 with bacterial vaginosis were randomly assigned into two groups and used either Leucorex Vaginal Cream or metronidazole gel every night for 5 nights. Their symptoms were assessed after 2-7 days of application of the drugs. The diagnostic tool for this assessment was Amsel criteria and gram stain of smears. Based on the results of this study, the symptoms of the patients and their Amsel criteria reduced significantly. Vaginal burning was reported in 14% of patients using Leucorex Vaginal Cream and in 4.5% using metronidazole vaginal gel. In patients using metronidazole vaginal gel, vertigo (6.8%) and metallic taste (4.5%) was present, but no such adverse reactions were reported with Leucorex Vaginal Cream. The researchers came to the conclusion that the therapeutic effect of Leucorex Vaginal Cream on bacterial vaginosis is identical to metronidazole vaginal gel. Therefore, for individuals who prefer taking herbal medications, or those who have suffered adverse reactions on metronidazole, Leucorex Vaginal Cream can be a suitable therapeutic choice for treatment of bacterial vaginosis.

Apply one applicator inside the vagina every night, for 7 to 10 consecutive nights.

Dosage Form

Vaginal Cream

 

Packaging

50 g tube with applicator in cardboard box

Patient information leaflet inside

Ingredients

Iranian thyme essential oil (Zataria multiflora)

Active Ingredients

thymol and carvacrol

Contraindications and Cautions

  • Pregnancy

 

Adverse Effects

Mild mucosal irritation. Few have reported burning sensation in the vagina following application of Leucorex cream, which seems improbable, given the results of clinical trials. Presence of vaginal ulcers in chronic cases may cause burning sensations, which would disappear following treatment and healing of the ulcer. 

Drug Interaction

No reported drug interaction.

 Administration during Pregnancy and Lactation

Not to be taken during pregnancy.

 

Further Notes

  • Complete the course of treatment.
  • In case burning, itching and intolerable irritation occurs, consult your physician.
  • In postmenopausal women, use only after consulting a physician.
  • Wash the vaginal applicator carefully after every time of use and store it in a clean place.
  • Like all other medication, keep Leucorex Vaginal Cream away from sight and reach of children.
  • After application, replace the cap on the tube and keep it away from light and in temperatures under 25°C.
  • Keep this leaflet; you may need to read it again.

Based on presence of at least 0.027-0.033 percent thymol in the product.