Vaginitis Clinical Trial
— MNZOfficial title:
Assiut University Hospital - Women Health Hospital
Verified date | February 2015 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | December 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Women with proven diagnosis of bacterial vaginosis infection from the Outpatient Gynecological Clinic in Women Health Center Assiut University. Exclusion Criteria: - Women refusal to participate in the study. - Pregnant and nursing Women. - Anticipation of difficulty of subsequent communication with the woman. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
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