Clinical Trials Logo
  1. Home
  2. Vaginal Infection
  3. NCT01812889

Evaluation of Intravaginal Gel and Ovule Formulations of TOL-463

Vaginal Infection Clinical Trial

Official title:
A Two Part Randomized, Open-Label Phase I Safety and Pharmacokinetic Evaluation of Gel and Ovule Formulations of TOL-463 (Intravaginal Therapy) in 18-45 Year Old Healthy Female Subjects and Women With Vaginitis

Clinical Trial Summary

The purpose of this study is to determine the safety, local tolerability and pharmacokinetic parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females following single dose administration (Part 1), and in nonpregnant women with vaginitis following multi-dose administration (Part 2).

Clinical Trial Description

The purpose of this study is to determine the safety, local tolerability and pharmacokinetic parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females following single dose administration (Part 1), and in nonpregnant women with vaginitis following multi-dose administration (Part 2). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01812889
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date April 2013
Completion date May 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT00324246 - Feasibility Study of the NEW NORMA-SENSE Phase 3
Recruiting NCT05021315 - Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection Phase 3
Not yet recruiting NCT05997160 - Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining
Recruiting NCT05557318 - Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge N/A
Completed NCT05044156 - Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
Completed NCT00694928 - Vaginal Infection Study 2 Phase 3
Not yet recruiting NCT05590195 - Effect of PreforPro® on Urinary and Vaginal Health Phase 3
Completed NCT03898726 - Laparoscopic Versus Transvaginal Cuff Closure N/A
Withdrawn NCT01542606 - Performance Proof of Product Developed to Detect Abnormal Vaginal pH N/A
Not yet recruiting NCT05806879 - Impact of Maternity Napkins on the Incidence of Vaginal Infections in the Post-partum Period N/A
Completed NCT02308046 - Multi-Center Study of New Medications to Treat Vaginal Infections Phase 3
Completed NCT02308007 - Multi-Center Study of New Medications to Treat Vaginal Infections Phase 3
Completed NCT02308033 - Multi-Center Study of New Medications to Treat Vaginal Infections Phase 3
Completed NCT01599416 - Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative N/A
Recruiting NCT04719754 - Epidemiology of Abnormal Vaginal Discharge During Pregnancy
Completed NCT03008421 - Oral Probiotics to Reduce Vaginal Group B Streptococcal Colonization in Late Pregnancy N/A
Completed NCT03261804 - Relation Between Internal Vaginal Douching and Vaginal Infections in Intrauterine Contraceptive Device Users
Terminated NCT05788991 - Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis Phase 4
Completed NCT01843166 - Vaginal Estrogen With Pessary Treatment N/A
Not yet recruiting NCT03532464 - Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection Phase 4