A clinical trial to study the effect of four different doses of a fixed dose combination of Sertaconazole + Secnidazole in patients with mixed vaginitis

A Double-Blind, Randomized, Four Arm, Dose Ranging (Phase IIb) Study to Assess the Efficacy, Safety and Tolerability of Sertaconazole plus Secnidazole vaginal tablets in adult female patients with mixed vaginitis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000112

Enrollment

148

Registered

2010-02-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Sertaconazole 500mg + Secnidazole 75mg: single dose vaginal tablet Intervention2: Sertaconazole 500mg + Secnidazole 150 mg: Single dose vaginal tablet Intervention3: Sertaconazole 500 m

Eligibility

Inclusion criteria

Inclusion criteria: Female patients with clinical [vaginal discharge/odor] & histopathologic diagnosis of mixed bacterial/fungal vaginitis, Age: 18 to 60 years; Non-pregnant (with negative Beta-human chorionic gonadotropin test) including breast feeding females; Patient willing to comply with study procedures and requirements

Exclusion criteria

Exclusion criteria: Pregnant and nursing women, history of allergy to Sertaconazole and/or Secnidazole,Use of topical contraceptive preparations,Anticipation of menses during treatment,Any other condition that in the opinion of the investigator does not justify the patient's participation in the study.

Design outcomes

Primary

Measure	Time frame
Improvement in clinical signs & symptoms such as Vaginal Discharge: Color & consistency; Odor, Pruritus, Burning, irritation/ Discomfort and signs such as Vaginal erythema, Vulvar erythema, Cervical erythema, polyp, erosion, Microbiological cure rate Clinical cureTimepoint: Baseline, days 7 and 14	—

Secondary

Measure	Time frame
Physician?s & Patient?s Global Assessment, Safety assessmentsTimepoint: Baseline, Days 7 and 14	—

Countries

India

Contacts

Public ContactChandrashekhar Bolmall

Medical Services Department

chandrashekharb@glenmarkpharma.com91-22-40189999

Outcome results