Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections

NCT01697826 | Completed Phase 4

• 2 other identifiers: ND1210132-34CTRI/2011/04/001698
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Infections

Keywords

Clindamycin; Clotrimazole; Vaginal formulation; Bacterial vaginosis; Candidiasis; Trichomoniasis; Mixed vaginitis; Infective vaginitis

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure for Global effectiveness

  Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis

  On 8th day after start of treatment

Secondary Outcomes (2)

• Secondary outcome measures for Global effectiveness

  29th day after initiation of treatment

• Secondary outcome measures for tolerability

  8th day after start of treatment

Other Outcomes (3)

• Clinical Response

  at 8th day and 29th day after initiation of treatment

• Clinical response

  at 8th and 29th day after start of treatment

• Clinical response

  at 8th day and 29th day after start of treatment

Study Arms (2)

ClinSupV3 -soft gelatin capsule

ACTIVE COMPARATOR

Soft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days

Drug: ClinSupV3 -soft gelatin capsule

ClinSupV3ER- Extended release tablet

ACTIVE COMPARATOR

ER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days.

Drug: ClinSupV3ER- Extended release tablet

Interventions

ClinSupV3 -soft gelatin capsule DRUG

3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole

Also known as: Clindamycin plus Clotrimazole

ClinSupV3 -soft gelatin capsule

ClinSupV3ER- Extended release tablet DRUG

3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole

Also known as: Clindamycin plus Clotrimazole

ClinSupV3ER- Extended release tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Bharti Daswani: lead
• Resilient Cosmeceuticals Pvt. Ltd, Pune: collaborator

Study Sites (1)

BJ Govt. Medical College & Sassoon General Hospitals, Pune

Pune, Maharashtra, 411001, India

Location

MeSH Terms

Conditions

Vaginitis; Vaginosis, Bacterial; Candidiasis; Trichomonas Infections

Interventions

Clindamycin; Clotrimazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Imidazoles; Azoles

Study Officials

• Bharti R Daswani, MD, PhD

  BJ Govt Medical College & Sassoon General Hospitals, Pune

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 29, 2012
• First Posted: October 2, 2012
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 2, 2012

Record last verified: 2012-09

Locations

IN (1)