Once Daily In-situ Forming Versus Twice-daily Conventional Metronidazole Vaginal Gels for Treatment of Bacterial Vaginosis

NCT02365389 | Completed Phase 2

• 1 other identifier: Vaginal gell
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

A previous study showed that in situ MTZ vaginal gel twice daily is more effective than the conventional vaginal gel product in sustained cure of BV( 4 weeks after treatment) (80.0% in the in-situ gel group as compared with 47.4 in the conventional gel group.The current study aims to compare the efficacy of the use of once daily in situ MTZ vaginal gel (0.8%) versus twice-daily conventional MTZ vaginal gel in treatment of BV.

Conditions

Vaginitis

Outcome Measures

Primary Outcomes (1)

• Clinical improvement of vaginitis.

  Therapeutic success will be defined as the presence of at least 3 signs of Amsel's criteria (Milky, homogeneous, adherent discharge; vaginal pH \> 4.5; release of fishy amine odor from vaginal fluid when mixed with 10% KOH (whiff test); and presence of \> 20 of clue cells).

  6 months

Study Arms (2)

Group A received in situ MTZ vaginal gel

ACTIVE COMPARATOR

Received in situ MTZ vaginal gel once daily for 5 days. Treatment in this group was offered in the form of a bottle of an aqueous liquid (100 mL of a preparation composed of 0.8% MTZ, 20% pluronic F-127, 10% pluronic F-68, and 0.01% benzalkonium chloride). Women were asked to put 5 cc of the liquid into the vagina once daily for 5 days using a graded syringe and 10-cm long soft applicator.

Drug: MTZ vaginal gel

Group B received conventional MTZ vaginal gel

ACTIVE COMPARATOR

Group B (control group) received conventional MTZ vaginal gel (Tricho gel 0.8%, Sedico, Egypt) twice daily for 5 days, using the supplied nozzle, which applies about 5 gm of gel again in the same laying back position.

Drug: Conventional MTZ vaginal gel

Interventions

MTZ vaginal gel DRUG

MTZ vaginal gel once daily for 5 days

Group A received in situ MTZ vaginal gel

Conventional MTZ vaginal gel DRUG

Conventional MTZ vaginal gel (Tricho gel 0.8%, Sedico, Egypt) twice daily for 5 days

Group B received conventional MTZ vaginal gel

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with proven diagnosis of bacterial vaginosis infection from the Outpatient Gynecological Clinic in Women Health Center Assiut University.

You may not qualify if:

• Women refusal to participate in the study.
• Pregnant and nursing Women.
• Anticipation of difficulty of subsequent communication with the woman.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Women Health hospital

Study Record Dates

• First Submitted: February 15, 2015
• First Posted: February 18, 2015
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 18, 2015

Record last verified: 2015-02