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AMP002 Phase III Contraceptive Study

NCT03243305 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1384

Last updated 2020-09-17

Study results available
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Summary

This is a single-arm, open-label, Phase III study in 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.

Conditions

  • Contraception

Interventions

DRUG

AMPHORA

non-hormonal contraceptive vaginal gel

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Evofem Inc.

    lead INDUSTRY

Principal Investigators

  • Kelly Culwell · Evofem Inc.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-24
Primary Completion
2018-11-29
Completion
2018-11-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03243305 on ClinicalTrials.gov