Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-09 @ 10:51 PM
Study NCT ID:
NCT03243305
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2017-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AMP002 Phase III Contraceptive Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kculwell@evofem.com', 'phone': '858 550 1900', 'title': 'Chief Medical Officer', 'organization': 'Evofem, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '10 months', 'description': 'An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.', 'eventGroups': [{'id': 'EG000', 'title': 'Interventional', 'description': 'This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.\n\nAMPHORA: non-hormonal contraceptive vaginal gel', 'otherNumAtRisk': 1330, 'deathsNumAtRisk': 1330, 'otherNumAffected': 601, 'seriousNumAtRisk': 1330, 'deathsNumAffected': 0, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 76}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vulvovaginal burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 266}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vulvovaginal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 51}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 149}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'seriousEvents': [{'term': 'Peritoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Uterine rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Premature separation of placenta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vaginal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Trisomy 21', 'notes': 'Pregnancy-related SAEs that were reported after study completion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Preeclampsia', 'notes': 'Pregnancy-related SAEs that were reported after study completion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Premature rupture of membrane', 'notes': 'Pregnancy-related SAEs that were reported after study completion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1330, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1182', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional', 'description': 'This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.\n\nAMPHORA: non-hormonal contraceptive vaginal gel'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Seven-cycle Pregnancy Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.65', 'ciLowerLimit': '9.91', 'ciUpperLimit': '17.39', 'groupDescription': 'The primary hypothesis to be tested is whether subjects using Amphora vaginal gel have a 7-cycle cumulative pregnancy percentage less than or equal to 21%', 'statisticalMethod': 'Kaplan-Meier', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'To evaluate the contraceptive efficacy of Amphora over 7-cycle of use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population that included only those subjects whose diaries indicated that they used the study drug correctly for every act of intercourse for at least 1 menstrual cycle. Cycles in which the study drug was used incorrectly for 1 or more coital acts were removed, and the remaining cycles were aligned in order to provide contiguous cycles.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional', 'description': 'This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.\n\nAMPHORA: non-hormonal contraceptive vaginal gel'}], 'classes': [{'title': 'Subjects with greater than or equal to 1 AE', 'categories': [{'measurements': [{'value': '601', 'groupId': 'OG000'}]}]}, {'title': 'Subjects with greater than or equal to 1 SAE', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to early discontinuation', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Relationship of AEs: unlikely to be Related', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}]}]}, {'title': 'Relationship of AEs: possibly related', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}]}]}, {'title': 'Relationship of AEs: probably related', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}, {'title': 'Relationship of AEs: definitely related', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}, {'title': 'Relationship of AEs: not assessable', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Intensity of AEs: mild', 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}]}]}, {'title': 'Intensity of AEs: moderate', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}]}]}, {'title': 'Intensity of AEs: severe', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Intensity of AEs: life-threatening', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'Incidence of AE to evaluate safety', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled into the study and who administered the study drug at least once.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interventional', 'description': 'This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.\n\nAMPHORA: non-hormonal contraceptive vaginal gel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1384'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '449'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '935'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '250'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '170'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'No sexually active', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Study method no longer primary method', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Early terminations', 'reasons': [{'groupId': 'FG000', 'numSubjects': '267'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Interventional', 'description': 'This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.\n\nAMPHORA: non-hormonal contraceptive vaginal gel'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'spread': '4.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1384', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '571', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '805', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '348', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '955', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI) at Screening', 'classes': [{'categories': [{'measurements': [{'value': '28.770', 'spread': '8.1079', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-01', 'size': 1587840, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-07T20:37', 'hasProtocol': True}, {'date': '2018-10-24', 'size': 780302, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-07T20:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Arm, unblinded'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1384}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'dispFirstSubmitDate': '2019-11-19', 'completionDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2017-06-29', 'dispFirstSubmitQcDate': '2020-07-07', 'resultsFirstSubmitDate': '2020-06-02', 'studyFirstSubmitQcDate': '2017-08-07', 'dispFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-07', 'studyFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy', 'timeFrame': '10 months', 'description': 'To evaluate the contraceptive efficacy of Amphora over 7-cycle of use'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Adverse Events (AE)', 'timeFrame': '10 months', 'description': 'Incidence of AE to evaluate safety'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Through assessments including pelvic examination, laboratory procedures, and medical and gynecological history, subjects will be screened for eligibility in order to enroll approximately 1349 subjects into the study. After a screening period of up to 60 days, enrolled women will receive study drug. Each woman will participate in the study until after she has completed treatment during seven study cycles. Women who have individual cycles that do not meet the criteria for an evaluable cycle will not have those cycles replaced by subsequent cycles in order to provide a total of seven evaluable cycles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inclusion Criteria:\n\nTo enroll in the clinical study, potential subjects must:\n\n1. Be healthy women, who are sexually active, at risk of pregnancy, and desiring contraception.\n2. Be within the age range of 18 to 35 years old (inclusive) at enrollment.\n3. In the opinion of the Investigator, be at low risk for both human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) based on review of high-risk behaviors and exposures according to the Centers for Disease Control STI Guideline.\n4. At the time of enrollment, have a single male sex partner for ≥3 months.\n5. Have a negative urine pregnancy test at enrollment.\n6. Have normal, cyclic menses with a usual length of 21 to 35 days over the last two cycles or at least two consecutive spontaneous menses (21 to 35 days in length) since delivery, abortion, or after discontinuing hormonal contraception or hormonal therapy prior to the date of consent. In addition:\n\n 1. If the subject recently discontinued breastfeeding, she must have demonstrated return to regular cycling and have had at least three consecutive, spontaneous menses post-lactation prior to the date of consent.\n 2. If the subject received prior administration of injectable contraceptives (e.g., depot-medroxyprogesterone acetate \\[DMPA\\], Depo Provera), there must be at least 10 months since the last injection and the subject must have had at least two consecutive, spontaneous menses prior to the date of consent.\n 3. If a contraceptive implant was recently removed, the subject must have had at least two consecutive, spontaneous menses prior to the date of consent.\n 4. If an intrauterine device (IUD) was recently removed, the subject must have had at least one spontaneous menses following removal and prior to the date of consent.\n7. Be willing to engage in at least three acts of heterosexual vaginal intercourse per cycle.\n8. Be willing to use the study drug as the only method of contraception over the course of the study (with the exception of emergency contraception \\[EC\\] in the event a subject engages in vaginal intercourse but believes that the study drug was not used properly or she is at risk for pregnancy for any other reason).\n9. Be capable of using the study drug properly and agree to comply with all study directions and requirements, including retaining the wrappers and returning them to the clinical site at the next study visit.\n10. Be willing to keep a daily electronic diary (eDiary) to record coital information, study drug use information, use of concomitant medications including other vaginal products and other contraceptives, menses, and sign and symptom data for the subject or as reported to her by her partner.\n11. Agree not to participate in any other clinical studies during the course of the study.\n12. Be capable and willing to give written informed consent to participate in the study.\n\nExclusion Criteria:\n\nExclusion Criteria:\n\nTo enroll in the clinical study, potential subjects must not:\n\n1. Have had three or more urinary tract infections (UTIs) in the past year from the date of consent.\n2. Have a UTI by urine culture, chlamydia, gonorrhea, or symptomatic yeast vaginitis or symptomatic bacterial vaginosis (BV) diagnosed by wet mount, or trichomoniasis, unless treated and proof of cure is documented within the screening period.\n3. Have used vaginal or systemic antibiotics or antifungals within 14 days prior to enrollment, with the exception of vaginal or systemic antibiotics or antifungals completed for the treatment of a UTI, BV, or yeast vaginitis diagnosed at screening within seven days of the Enrollment Visit.\n4. Have a history of any recurrent vaginal infections/disorders (either greater than or equal to four times in the past year or greater than or equal to three times in the previous six months from the date of consent).\n5. Be pregnant, have a suspected pregnancy, or desire to become pregnant during the course of the study.\n6. Have a history of diagnosed infertility or of conditions that may lead to infertility, without subsequent non-assisted reproductive technology intrauterine pregnancy.\n7. Have any maternal contraindications to pregnancy (medical condition) or chronic use of medications for which significant evidence of fetal risk exists.\n8. Have known or screen test positive for HIV infection.\n9. Have three or more outbreaks of genital herpes simplex virus (HSV) within the last year from the date of consent or be receiving suppressive therapy.\n10. Have visible genital condylomata (warts).\n11. Be lactating or breastfeeding.\n12. Have any clinically significant abnormal finding on physical examination including pelvic examination or baseline laboratory assessments which in the opinion of the Investigator, precludes study participation.\n13. Have clinically significant signs of vaginal or cervical irritation on pelvic examination.\n14. Be planning to have any (e.g., diagnostic or therapeutic) vaginal or cervical procedures during the period of the study.\n15. Have an abnormal Papanicolaou test (Pap test) based on the following criteria:\n\n a. Pap test in the past 12 months from the date of screening with atypical squamous cells of undetermined significance (ASC-US) unless at least one of the following criteria is met: i. Less than 21 years of age. ii. A repeat Pap test at least six months later was normal. iii. Reflex human papillomavirus (HPV) testing was performed and was negative for high-risk HPV.\n\n iv. A colposcopy (with or without biopsy) found no evidence of dysplasia requiring treatment or treatment was performed and follow up at least six months after the treatment showed no evidence of disease.\n\n b. Pap test in the past 12 months from the date of screening with low grade squamous intraepithelial lesion (LSIL) unless at least one of the following criteria is met: i. Less than 21 years of age. ii. A colposcopy (with or without biopsy) found no evidence of dysplasia requiring treatment or treatment was performed and follow up at least six months after the treatment showed no evidence of disease.\n\n c. Pap test in the past 12 months from the date of screening with atypical squamous cells in which high grade squamous intraepithelial lesion cannot be excluded (ASC-H), atypical glandular cells, high grade squamous intraepithelial lesion (HSIL), or ≥30 years old who are cytology negative and HPV 16- or HPV 18-positive unless colposcopy and/or treatment was performed and follow up at least six months after the colposcopy and/or treatment showed no evidence of disease.\n\n d. Pap test in the past 12 months with malignant cells.\n16. Consume (on average) more than three drinks of an alcoholic beverage per day.\n17. In the opinion of the Investigator, have a history of substance abuse in the last 12 months.\n18. Have taken an investigational drug or used an investigational device within the past 30 days from the date of consent.\n19. In the opinion of the Investigator, have issues or concerns that may compromise the safety of the subject, impact the subject's compliance with the protocol requirements, or confound the reliability of the data acquired.\n20. Be an Evofem, PAREXEL, or clinical site employee regardless of direct involvement in research activities, or their close relative."}, 'identificationModule': {'nctId': 'NCT03243305', 'briefTitle': 'AMP002 Phase III Contraceptive Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Evofem Inc.'}, 'officialTitle': 'AMPOWER A Single-arm, Phase III, Open Label, Multi-center, Study in Women Aged 18-35 Years of the Contraceptive Efficacy and Safety of Phexxi™ (Previously Referred to as AMPHORA®) Contraceptive Vaginal Gel', 'orgStudyIdInfo': {'id': 'AMP002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'This 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.', 'interventionNames': ['Drug: AMPHORA']}], 'interventions': [{'name': 'AMPHORA', 'type': 'DRUG', 'description': 'non-hormonal contraceptive vaginal gel', 'armGroupLabels': ['Interventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Clinical Research, Inc.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'East Valley Family Physicians 137', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85209', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mesa Obstetricians & Gynecologists 184', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Family Practice Specialists Ltd 170', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Precision Trials AZ, LLC 176', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research, Inc. 111', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Visions Clinical Research Tucson 138', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Eclipse Clinical Research 185', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Primary Care Clinic 205', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC 135', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '94710', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Essential Access Health 159', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '91303', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'Hope Clinical Research, LLC 163', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Grossmont Center for Clinical Research 119', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Research 179', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research 101', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Optimal Research, LLC 149', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Women's Health Care 122", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor - 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