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AMPHORA

Phase 3

Contraception | Small Molecules | Endocrine |Evofem Biosciences, Inc.|Trials Updated: Sep 17, 2020

AMPHORA development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Mar 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment1,384

FDA Designations

No designations recorded

AMPHORA clinical trials

AMPHORA · 1 trial · 1 indication

Phase 3 1
NCT03243305AMP002 Phase III Contraceptive StudyContraception
COMPLETED1,384 Analytics
PHASE3COMPLETED
AMP002 Phase III Contraceptive Study
Contraception
NCT032433051,384
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Study Endpoints

Primary Endpoints

Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy
10 months

To evaluate the contraceptive efficacy of Amphora over 7-cycle of use

Secondary Endpoints

Number of Subjects With Adverse Events (AE)
10 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
InterventionalEXPERIMENTALThis is a single-arm, open-label, Phase III study of AMPHORA , a non-hormonal contraceptive, at approximately 100 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.

Interventions

NameTypeDescription
AMPHORADRUGnon-hormonal contraceptive vaginal gel
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersNo
Study Sites87

Inclusion Criteria: * Inclusion Criteria: To enroll in the clinical study, potential subjects must: 1. Be healthy women, who are sexually active, at risk of pregnancy, and desiring contraception. 2. Be within the age range of 18 to 35 years old (inclusive) at enrollment. 3. In the opinion of the ...

Countries:United States
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