Clinical trial NCT01697826: Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections
Official title: A Comparative Open Labeled Clinical Study to Evaluate the Efficacy and Tolerability of Two Different Intravaginal Formulations Containing a Combination of Clindamycin and Clotrimazole in Vaginal Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginal Infections
Keywords: Clindamycin
Clotrimazole
Vaginal formulation
Bacterial vaginosis
Candidiasis
Trichomoniasis
Mixed vaginitis
Infective vaginitis
Lead sponsor: Daswani, Bhart, M.D.
Sponsor class: INDIV
Collaborators: name: Resilient Cosmeceuticals Pvt. Ltd, Pune
First posted: 2012-10-02
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective vaginitis.

Detailed description: * This is a Randomized, Comparative, Prospective, Open label, Single center study to compare the 3 day treatment course of intravaginal soft gelatin capsule containing clindamycin and clotrimazole versus intravaginal ER tablets of clindamycin and clotrimazole in patients with vaginal discharge and clinical diagnosis of bacterial, trichomonal, candidal or mixed vaginitis with respect to efficacy and tolerability; and to study the in vitro drug release pattern of intravaginal soft gelatin capsule and intravaginal ER tablets containing clindamycin and clotrimazole.
* The study will be conducted in B.J. Medical College \& Sassoon General Hospitals, Pune. The study will be completed in 60 patients \[30 patients in each group\].
* The primary outcome measure is absence of any clinical sign suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 8th day after start of treatment \[Effectiveness in inducing a remission\].
* The secondary outcome measures will be

  1. absence of any clinical sign suggestive of infective vaginitis and
  2. a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 29th day after start of treatment \[Effectiveness in maintaining a remission\] and ability to complete the 3day course without any break or experiencing intolerable side effects \[Tolerability\].

Eligibility criteria: Inclusion Criteria:

* Women with symptoms of vaginal discharge and/or odor and a clinical diagnosis of vaginitis of infective origin \[based on symptoms and signs on per speculum examination\]
* Age at least 18 years
* Capable of giving written informed consent
* Agree to no intercourse for 8 days from the day of start of treatment
* Agree not to douche or use any intravaginal products during the study period (including tampons, medications and devices)

Exclusion Criteria:

* Post-menopausal women
* Menstruating at diagnosis
* Pregnancy
* Any antifungal or antibiotic use 14 days prior to enrolment
* Use of oral or intravaginal antibiotics within the past 2 weeks
* Immunosuppressive drug within 4 months
* Presence of vaginal / vulval ulcer
* Presence of any other vulval, vaginal or medical condition, including cervical neoplasia/ treatment that might confound treatment response
* Inability to keep return appointments
* History of hypersensitivity to clotrimazole, clindamycin or lincomycin
* History of regional enteritis, ulcerative colitis or antibiotic associated colitis
* Significant disease or acute illness that in the Investigators assessment could complicate the evaluation
* Intrauterine Device

Primary outcomes:
measure: Primary outcome measure for Global effectiveness
timeFrame: On 8th day after start of treatment
Secondary outcomes:
measure: Secondary outcome measures for Global effectiveness
timeFrame: 29th day after initiation of treatment
measure: Secondary outcome measures for tolerability
timeFrame: 8th day after start of treatment
Other outcomes:
measure: Clinical Response
timeFrame: at 8th day and 29th day after initiation of treatment
measure: Clinical response
timeFrame: at 8th and 29th day after start of treatment
measure: Clinical response
timeFrame: at 8th day and 29th day after start of treatment
Locations:
city: Pune
country: India
facility: BJ Govt. Medical College & Sassoon General Hospitals, Pune
state: Maharashtra
Study officials:
affiliation: BJ Govt Medical College & Sassoon General Hospitals, Pune
name: Bharti R Daswani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: