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Phase 2B/3 Double-Blinded Placebo-Controlled Efficacy Trial of AMPHORA® Gel for the Prevention of Acquisition of Urogenital Chlamydia Trachomatis Infection

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Phase 2B/3 Double-Blinded Placebo-Controlled Efficacy Trial of AMPHORA® Gel for the Prevention of Acquisition of Urogenital Chlamydia Trachomatis Infection AMPHORA® Protocol: EVO-003 Evofem, Inc. v6.0 – 25 January 2019 Phase 2B/3 double-blinded placebo-controlled efficacy trial of AMPHORA® gel for the prevention of acquisition of urogenital Chlamydia trachomatis infection Protocol Number: EVO-003 Sponsor: Evofem, Inc. 12400 High Bluff Drive, Suite 600 San Diego, CA 92130 CRO: ICON Government and Public Health Solutions (GPHS) 1265 Ridge Road Hinckley, OH 44233 Investigational Product: AMPHORA (L-lactic acid, citric acid and potassium bitartrate) Vaginal Gel 1.8%/1%/0.4% IND Number: 128092 Protocol Version Number: Version 6.0 January 25, 2019 CONFIDENTIAL AND PROPRIETARY Page 1 of 76 AMPHORA® Protocol: EVO-003 Evofem, Inc. v6.0 – 25 January 2019 Statement of Compliance This study will be carried out in accordance with the US Code of Federal Regulations (CFR), local regulations, and Good Clinical Practice (GCP) as required by the following: • 21 CFR 50, 21 CFR 56, and 21 CFR 312 • International Council for Harmonisation (ICH E6); 62 Federal Register 25691 (1997) All individuals responsible for the design and conduct of this study have completed Human Subjects Protection Training and are qualified to be conducting research prior to the enrollment of any subjects. CVs for all Investigators and Sub-Investigators participating in this study are on file in a central facility (21 CFR 312.23 [a] [6] [iii] [b] edition). CONFIDENTIAL AND PROPRIETARY Page 2 of 76 AMPHORA® Protocol: EVO-003 Evofem, Inc. v6.0 – 25 January 2019 Signature Page for the Investigator Phase 2B/3 double-blinded placebo-controlled efficacy trial of AMPHORA® gel for the prevention of acquisition of urogenital Chlamydia trachomatis infection Protocol Number: EVO-003 The signature below constitutes the approval of this protocol and the attachments and provides the necessary assurances that this study will be conducted according to all stipulations of the protocol, including all statements regarding confidentiality, and according to local legal and regulatory requirements and applicable US state and federal regulations, all other applicable local regulatory requirements, and applicable US Food and Drug Administration regulations. Organization Name Investigator Signature Date Print Name CONFIDENTIAL AND PROPRIETARY Page 4 of 76 AMPHORA® Protocol: EVO-003 Evofem, Inc. v6.0 – 25 January 2019 Table of Contents Protocol Synopsis ...........................................................................................................................9 List of Abbreviations ...................................................................................................................15 1 Background Information and Scientific Rationale .............................................................17 1.1 Background Information ...........................................................................................17 1.2 Scientific Rationale ...................................................................................................18 1.3 Study Objectives .......................................................................................................18 2 Study Design ...........................................................................................................................20 2.1 Study Outcome Measures .........................................................................................21 2.1.1 Primary Outcome Measures ..........................................................................21 2.1.2 Secondary Outcome Measures ......................................................................21 2.1.3 Exploratory Outcome Measures ...................................................................22 2.2 Study Population .......................................................................................................22 2.3 Study Schedule..........................................................................................................22 3 Study Enrollment and Retention ..........................................................................................23 3.1 Inclusion Criteria ......................................................................................................23 3.2 Exclusion Criteria .....................................................................................................24 3.3 Prohibited Medications .............................................................................................25 3.4 Randomization ..........................................................................................................25 3.5 Blinding.....................................................................................................................26 3.6 Withdrawal ................................................................................................................26 3.6.1 Reasons for Withdrawal ................................................................................26 3.6.2 Handling of Withdrawal ...............................................................................27 3.6.3 Handling Subjects Lost to Follow-up ...........................................................27 3.6.4 Replacement of Subjects Lost to Follow-up and Withdrawal ......................28 3.7 Subject Completion ...................................................................................................28 3.8 Termination of the Study ..........................................................................................28 4 Study Products .......................................................................................................................29 4.1 Study Products Description.......................................................................................29 4.1.1 Formulation and Packaging ..........................................................................29 4.1.2 Product Supply ..............................................................................................30 4.1.3 Product Storage, Stability, and Expiration ....................................................30 4.1.4 Preparation ....................................................................................................30 4.1.5 Distribution to Subjects/Return of Unused Product and Used Applicators ..30 4.1.6 Administration ..............................................................................................30 5 Study Procedures/Evaluations ..............................................................................................32 5.1 Written Informed Consent ........................................................................................32 5.2 Inclusion/Exclusion Criteria .....................................................................................32 5.3 Evaluation of Eligibility Criteria ..............................................................................32 CONFIDENTIAL AND PROPRIETARY Page 5 of 76 AMPHORA® Protocol: EVO-003 Evofem, Inc. v6.0 – 25 January 2019 5.4 Demographics ...........................................................................................................32 5.5 Clinical Evaluations ..................................................................................................33 5.5.1 Medical History ............................................................................................33 5.5.2 Vital Signs .....................................................................................................33 5.5.3 Gynecologic Examinations ...........................................................................33 5.5.4 Concomitant Medications .............................................................................33 5.5.5 Height and Weight ........................................................................................33 5.6 Laboratory Evaluations .............................................................................................34 5.6.1 Pregnancy Testing .........................................................................................34 5.6.2 Vaginal pH Testing .......................................................................................34 5.6.3 Nucleic Acid Amplification Tests for Chlamydia trachomatis/Neisseria gonorrhoeae ..................................................................................................34 5.6.4 Staining of Used Applicators ........................................................................34 5.7 Subject eDiaries ........................................................................................................35 5.8 Procedures by Visit ...................................................................................................35 5.8.1 Screening (Visit 0; Weeks -6-0) ...................................................................35 5.8.2 Rescreening ...................................................................................................36 5.8.3 Enrollment/Visit 1 (Week 0 ±7 days) ...........................................................36 5.8.4 Visits 2 Through 4 (Weeks 4-12 ±7 days) ....................................................37 5.8.5 Visit 5 (Week 16 ±7 days) ............................................................................37 5.8.6 Post-intervention Follow-up Visit/Visit 6 (Week 20 ±7 days) .....................38 5.9 Unscheduled Visit(s) .................................................................................................38 5.10 Early Termination .....................................................................................................38
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