Trial Outcomes & Findings for Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis (NCT NCT02180100)
NCT ID: NCT02180100
Last Updated: 2020-10-23
Results Overview
Based on candida culture
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
140 participants
Primary outcome timeframe
Between day 7-14 after treatment, an average of 10 days
Results posted on
2020-10-23
Participant Flow
At Clinic
Participant milestones
| Measure |
Terconazole Vaginal Suppository
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Terconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
|
Fluconazole
Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Fluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
58
|
66
|
|
Overall Study
NOT COMPLETED
|
12
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Baseline characteristics by cohort
| Measure |
Terconazole Vaginal Suppository
n=70 Participants
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Terconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
|
Fluconazole
n=70 Participants
Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Fluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
|
Total
n=140 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
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between day 7-14 after treatment, an average of 10 daysBased on candida culture
Outcome measures
| Measure |
Terconazole Vaginal Suppository
n=58 Participants
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Terconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
|
Fluconazole
n=66 Participants
Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Fluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
|
|---|---|---|
|
Mycological Cure 1
|
46 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Between day 28-35 after treatment, an average of 30 daysBased on Candida culture
Outcome measures
| Measure |
Terconazole Vaginal Suppository
n=58 Participants
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Terconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
|
Fluconazole
n=66 Participants
Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Fluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
|
|---|---|---|
|
Mycological Cure 2
|
36 Participants
|
35 Participants
|
Adverse Events
Terconazole Vaginal Suppository
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fluconazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Shangrong Fan
Peking University Shenzhen Hospital
Phone: 86755-83923333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60