Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole

NCT07247851 | Completed DMC

• 1 other identifier: Bacterial Vagionos
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria; this alteration causes offensive smelling vaginal discharge, leading to significant psychological distress and a reduction in quality of life and may be associated with adverse outcomes following a gynecological/obstetrical surgical intervention, such as an increased risk of post-operative infections after pelvic surgery. It has been observed in 29% of reproductive-age individuals in the United States, and the prevalence of BV varies with race and ethnicity

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Bacterial Vaginosis treatment

  Assessment of the female patients whom suffering from Bacterial Vaginosis by Complete history description to changes of discharge odour and symptoms of vulvovaginitis as itching. and efficacy of both medications (reliving symptoms of BV as discharge \& odour) .

  At 2 weeks and through 6 months

Study Arms (2)

Group A (Clindamycine with Metronidazole)

ACTIVE COMPARATOR

About 50 female patients used Vaginal Clindamycin vaginal cream: 2% and Oral Metronidazole tablets in the treatment of Bacterial Vaginosis

Drug: Clindamycin Phosphate

Group B (Metronidazole)

ACTIVE COMPARATOR

About 50 female patients used Metronidazole tables in the treatment of Bacterial Vaginosis

Drug: Clindamycin Phosphate

Interventions

Clindamycin Phosphate DRUG

comparing the efficacy of the combined use of vaginal clindamycin cream and oral metronidazole in comparison to oral metronidazole alone for bacterial vaginosis treatment.

Also known as: Metronidazole

Group A (Clindamycine with Metronidazole); Group B (Metronidazole)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged ≥ 18 years with a clinical diagnosis and laboratory diagnosis as (cervical smear \& high vaginal swab) of bacterial vaginosis.
• Diagnosed with Bacterial vaginosis the Amsel scoring system which requires 3 criteria of 4 criteria for diagnosis.:
• The presence of homogeneous, thin, greyish white vaginal discharge.
• Vaginal pH over 4.5.
• Positive whiff-amine test (the presence of a fishy odor following addition of KOH to the vaginal sample).
• More than 20% clue cells/high power field on a wet mount of vaginal secretions.

You may not qualify if:

• Other types of infections based on history and clinical examination as candida vaginitis (itching with cottage cheese whitish discharge, Trichomonas vaginalis (with yellowish green offensive discharge) and any sexually transmitted disease (STDs) as gonorrhea(watery creamy greenish discharge, pain on micturation)syphilis(appearance of shung-kur ulcer, painless sore), chlamydia(abnormal discharge from vagina, burning sensation on peeing, abnormal discharge from penis) or genital herpes (tingling, burning, itching around genitals on both parteners).
• Pregnant and lactating females
• Any contraindication or hypersensitivity to metronidazole use
• Use of other antibiotics or systemic antifungal agents within the previous 2 weeks or planned use within 2 weeks
• Use of topical vaginal antibiotics, antifungals or acidifying products recently or planned within 2 weeks
• Atrophic vaginitis
• Using IUD as contraceptive method because IUD is a risk factor for infection

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Abbasia, Egypt

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

clindamycin phosphate; Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Laila Aly Farid, Professor

  Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology at Faculty of Medicine

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: January 10, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 10, 2024
• Last Updated: November 25, 2025

Record last verified: 2024-01

Locations

EG (1)