Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gynoclin V · 1 trial · 2 indications
Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.
Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.
Percentage of participants with the presence of microorganisms (Candida albicans, Candida species, Gardnerella vaginalis, Vaginal flora, Lactobacillus species) in the wet mount, KOH, gram stain and vaginal discharge culture (candida and symptomatology) 3 days after treatment.
| Arm | Type | Description |
|---|---|---|
| Gynoclin V | EXPERIMENTAL | One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days. |
| Vagitrol V | EXPERIMENTAL | One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days. |
| Name | Type | Description |
|---|---|---|
| Gynoclin V | DRUG | One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days. |
| Vagitrol V | DRUG | One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days. |
Inclusion Criteria: * Participants presenting clinical symptoms compatible with vaginitis/bacterial vaginosis, with any of the following symptoms being the reason for the consultation: pruritus (itchiness), vulvar burning, as well as presenting leukorrhea (a clear or white discharge from the vagina...
Gynoclin V is an investigational small molecule being developed for the treatment of vaginitis, specifically secondary vulvar or vaginal symptoms of infectious vaginitis and infectious vaginosis. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Gynoclin V is being developed by Johnson & Johnson, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 3 clinical trials for the treatment of vaginitis.
Gynoclin V is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. One Phase 3 clinical trial for the drug has been completed.
Gynoclin V has one completed Phase 3 clinical trial, identified as NCT01867164. This randomized, controlled study enrolled 160 female participants in Mexico and compared an ovule containing terconazole, clindamycin, and fluocinolone versus an ovule containing metronidazole, nystatin, and fluocinolone for the treatment of secondary vulvar or vaginal symptoms of infectious vaginitis and infectious vaginosis.
No, Gynoclin V is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the treatment of vaginitis. The drug has completed one clinical trial, but it has not yet received regulatory approval.