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Acidform

Phase 1

Undisclosed | Small Molecules | Other |Evofem Biosciences, Inc.|Trials Updated: Nov 20, 2020

Acidform target and mechanism

ModalitySmall Molecules

Also known as Acidform 5 g

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Acidform clinical trials

Acidform · 1 trial · 1 indication

Phase 1 1
NCT02693418Duration of Effect of Acidform Gel on Vaginal pHHealthy
COMPLETED105 Analytics
PHASE1COMPLETED
Duration of Effect of Acidform Gel on Vaginal pH
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Study Endpoints

Primary Endpoints

Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention.
Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.

Vaginal swabs were used to collect samples from the vagina of women dosed with Acidform, HEC placebo, or no treatment. The pH of the samples was measured at pre-determined time points over the course of 7 days.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Acidform Gel, Group AEXPERIMENTALAdministration of a single vaginal dose of Acidform gel (5 g)
Acidform Gel, Group BEXPERIMENTALAdministration of a single vaginal dose of Acidform gel (4 g)
Acidform Gel, Group CEXPERIMENTALAdministration of a single vaginal dose of Acidform gel (3 g)
Placebo Gel, Group DPLACEBO_COMPARATORAdministration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)
No intervention, Group ENO_INTERVENTIONNo vaginal product administered

Interventions

NameTypeDescription
Acidform 5 gDRUGEffect of 5 g vaginally administered Acidform on pH over 7 days
Placebo 4 gDRUGEffect of 4 g of vaginally administered HEC placebo gel on pH over 7 days
Acidform 4 gDRUGEffect of 4 g vaginally administered Acidform on pH over 7 days
Acidform 3 gDRUGEffect of 3 g vaginally administered Acidform on pH over 7 days
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Healthy female subjects between 18 and 45 years, inclusive 2. Ability to understand the consent process and procedures 3. Subjects agree to be available for all study visits 4. Written informed consent in accordance with institutional guidelines 5. Negative pregnancy test 6. ...

Countries:United States
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