Pelvic Inflammatory Disease Clinical Trial
— CTOOfficial title:
Phase 4 Study of Azitromicin in the Treatment of PID
Verified date | October 2010 |
Source | Guilan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ministry of Health |
Study type | Interventional |
Objective: To compare two oral treatments: Ofloxacin + Metronidazole, and Azitromycin
+Metronidazole in outpatients with Pelvic Inflammatory Disease.
Materials and Methods: Two hundred patients divided to two groups( A , B). Group A (treated
by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine
1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria:Eligibility criteria were having three out of five following symptoms:
a-lower abdominal pain, b-vaginal discharges, c- adnexal tenderness, d-cervical motion
tenderness (CMT), e-cervisitis. Exclusion Criteria:Excluding criteria were as follows: a-unmarried women, b-pregnant women, c-women with infection during menstruation, d- history of abortion or miscarriage during the last month, e-underlying diseases such as diabetes, f-used antibiotics in the last month, or allergy to the antibiotics used in the study, g-history of Pelvic Inflammatory Disease within the last year, and h- suspicion of being multi partner. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Alzahra Maternity Hospital | Rasht | Guilan |
Lead Sponsor | Collaborator |
---|---|
Guilan University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | to compare two oral antibiotic protocols in terms of side effects and efficacy. | side effects- and efficacy | Jan 2010- Aug 2010 | Yes |
Secondary | single oral dose of Azitromicine could be the drug of choice in the outpatient treatment of Pelvic Inflammatory Disease | compliance and cost | Jan 2010- Aug 2010 | Yes |
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