Trial Outcomes & Findings for Treatment of Bacterial Vaginosis (BV) With Tinidazole (NCT NCT00334633)

NCT ID: NCT00334633

Last Updated: 2017-12-02

Results Overview

resolution of Amsel criteria for bacterial vaginosis

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 593 participants
• Primary outcome timeframe: one month
• Results posted on: 2017-12-02

Participant Flow

women attending a sexually transmitted disease (STD) clinic with symptomatic bacterial vaginosis (BV)

Participant milestones

Measure	Metronidazole metronidazole 500 twice a day (BID) for 7 days; 197 participants	Tinidazole 500 mg tinidazole 500 BID for 7 days; 200 particpants	Tinidazole 1 gm tinidazole 1 gm BID for 7 days; 196 particpants
Overall Study STARTED	197	200	196
Overall Study COMPLETED	117	118	114
Overall Study NOT COMPLETED	80	82	82

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Bacterial Vaginosis (BV) With Tinidazole

Baseline characteristics by cohort

Measure	Metronidazole n=197 Participants metronidazole 500 BID for 7 days; 197 participants	Tinidazole 500 mg n=200 Participants tinidazole 500 BID for 7 days; 200 particpants	Tinidazole 1 gm n=196 Participants tinidazole 1 gm BID for 7 days; 196 particpants	Total n=593 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	197 Participants n=5 Participants	200 Participants n=7 Participants	196 Participants n=5 Participants	593 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	28 years STANDARD_DEVIATION 6.2 • n=5 Participants	28.3 years STANDARD_DEVIATION 6.6 • n=7 Participants	28.5 years STANDARD_DEVIATION 6.8 • n=5 Participants	28.3 years STANDARD_DEVIATION 6.7 • n=4 Participants
Sex: Female, Male Female	197 Participants n=5 Participants	200 Participants n=7 Participants	196 Participants n=5 Participants	593 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	197 participants n=5 Participants	200 participants n=7 Participants	196 participants n=5 Participants	593 participants n=4 Participants

PRIMARY outcome

Timeframe: one month

Population: ITT

resolution of Amsel criteria for bacterial vaginosis

Outcome measures

Measure	Metronidazole n=117 Participants metronidazole 500 BID for 7 days; 197 participants	Tinidazole 500 mg n=118 Participants tinidazole 500 BID for 7 days; 200 particpants	Tinidazole 1 gm n=114 Participants tinidazole 1 gm BID for 7 days; 196 particpants
Cure of Bacterial Vaginosis	75 participants	73 participants	77 participants

SECONDARY outcome

Timeframe: baseline to 4 weeks

Outcome measures

Measure	Metronidazole n=117 Participants metronidazole 500 BID for 7 days; 197 participants	Tinidazole 500 mg n=114 Participants tinidazole 500 BID for 7 days; 200 particpants	Tinidazole 1 gm n=118 Participants tinidazole 1 gm BID for 7 days; 196 particpants
Recurrence of BV	42 Participants	45 Participants	37 Participants

Adverse Events

Metronidazole

Serious events: 0 serious events

Other events: 87 other events

Deaths: 0 deaths

Tinidazole 500 mg

Serious events: 0 serious events

Other events: 109 other events

Deaths: 0 deaths

Tinidazole 1 gm

Serious events: 0 serious events

Other events: 145 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Metronidazole n=197 participants at risk metronidazole 500 BID for 7 days; 197 participants	Tinidazole 500 mg n=200 participants at risk tinidazole 500 BID for 7 days; 200 particpants	Tinidazole 1 gm n=196 participants at risk tinidazole 1 gm BID for 7 days; 196 particpants
Infections and infestations vaginal candidiasis	25.4% 32/126 • Number of events 32	20.5% 33/161 • Number of events 33	13.8% 27/196 • Number of events 27
Gastrointestinal disorders gastrointestinal	31.0% 39/126 • Number of events 39	33.5% 54/161 • Number of events 54	46.4% 91/196 • Number of events 91
Nervous system disorders headache	12.7% 16/126 • Number of events 16	13.7% 22/161 • Number of events 22	13.8% 27/196 • Number of events 27

Additional Information

jane R Schwebke, MD

University of Alabama at Birmingham

Phone: 205-975-5665

Email: schwebke@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place