Trial Outcomes & Findings for An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film (NCT NCT04731818)
NCT ID: NCT04731818
Last Updated: 2025-01-15
Results Overview
Number of progressively motile sperm in aspirated endocervical mucus when using ZB-06 prior to intercourse.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
20 participants
Primary outcome timeframe
2-3 hours after sexual intercourse.
Results posted on
2025-01-15
Participant Flow
Participant milestones
| Measure |
ZB-06
All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse.
ZB-06: ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.
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|---|---|
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Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only participants that completed baseline and product PCT visits
Baseline characteristics by cohort
| Measure |
ZB-06
n=8 Participants
All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse.
ZB-06: ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.
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|---|---|
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Age, Continuous
|
39.8 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex/Gender, Customized
Female
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8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants • Only participants that completed baseline and product PCT visits
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants • Only participants that completed baseline and product PCT visits
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Only participants that completed baseline and product PCT visits
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants • Only participants that completed baseline and product PCT visits
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Only participants that completed baseline and product PCT visits
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Only participants that completed baseline and product PCT visits
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants • Only participants that completed baseline and product PCT visits
|
|
Race (NIH/OMB)
White
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5 Participants
n=5 Participants • Only participants that completed baseline and product PCT visits
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants • Only participants that completed baseline and product PCT visits
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Only participants that completed baseline and product PCT visits
|
|
Region of Enrollment
United States
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8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-3 hours after sexual intercourse.Population: Data from all participants who complete both the baseline and the product use post coital test visits
Number of progressively motile sperm in aspirated endocervical mucus when using ZB-06 prior to intercourse.
Outcome measures
| Measure |
ZB-06
n=8 Participants
All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse.
ZB-06: ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.
|
|---|---|
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Surrogate Contraceptive Efficacy
Product Use Post Coital Test
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0.04 sperm per high power field
Standard Deviation 0.06
|
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Surrogate Contraceptive Efficacy
Baseline Post Coital Test
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25.86 sperm per high power field
Standard Deviation 30.58
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Surrogate Contraceptive Efficacy
Post Product Use Post Coital Test
|
47.39 sperm per high power field
Standard Deviation 37.43
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SECONDARY outcome
Timeframe: Baseline through study exit encompassing a minimum of three menstrual cycles of 21-35 days.Population: Assess the incidence of Grade 2 or greater adverse events (AEs) in the participant and/or her male partner in the interval between baseline visit 4 and visit 6.
Incidence of Grade 2 or Greater Adverse Events during product use versus during baseline observation.
Outcome measures
| Measure |
ZB-06
n=1 Number of TEAEs
All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse.
ZB-06: ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.
|
|---|---|
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Adverse Events
Product use
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1 Number of TEAEs
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Adverse Events
Post Product Use
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0 Number of TEAEs
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Adverse Events
ZB-06
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ZB-06
n=8 participants at risk
All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse.
ZB-06: ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.
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|---|---|
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Renal and urinary disorders
Hyperkalemia
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12.5%
1/8 • Number of events 1 • AE event monitoring for this study will began at the time of informed consent (Visit 1) through the last (visit 10), on average 3 months. First Screening was conducted February 8, 2021, and last subject last visit was February, 24, 2022.
From the time of informed consent to last visit
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Additional Information
Andrea Thurman MD, Principal Investigator
Eastern Virginia Medical School
Phone: 7574465808
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place