Chlamydia, Gonorrhea, Sexually Transmitted Diseases
Conditions
Brief summary
This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection
Detailed description
In this phase 3 double blind placebo controlled, efficacy study, women who have had a urogenital chlamydia or gonorrhea infection at any time over the 16 weeks preceding the enrollment Visit with one or more risk factors, or found to be positive for either infection at Screening Visit with one or more risk factors will be enrolled. After a screening period of up to 35 days, women will be randomized to receive either EVO100 vaginal gel or placebo. Each woman will participate in the study until she has completed 16 weeks of study medication or observation or tests positive for CT or GC infection.
Interventions
DRUGEVO100
EVO100 vaginal gel
DRUGPlacebo
Placebo vaginal gel
Sponsors
Evofem Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subject Recruitment: EVOGUARDStudy.com/ct Inclusion Criteria: * Subjects must meet both of the following criteria: 1. Urogenital CT and/or GC infection (documented in a retrievable medical record) within the 16 weeks prior to enrollment and one or more of the additional risk factors included below: * 18 to 24 years of age at the screening visit * New sex partner within the past 12 weeks (84 days) * More than one current sex partner * Knowledge that current sex partner has multiple partners * Partner with known sexually transmitted infection (STI) * Inconsistent condom use among persons who are not in a mutually monogamous relationship 2. After three unsuccessful documented attempts to obtain medical records, the subject has a self-reported history of infection less than 17 weeks prior to enrollment AND two or more of the following additional risk factors: * 18 to 24 years of age at the screening visit * New sex partner within the past 12 weeks (84 days) * More than one current sex partner * Knowledge that current sex partner has multiple partners * Partner with known STI * Inconsistent condom use among persons who are not in a mutually monogamous relationship * Ability to understand the consent process and procedures. For minors, the ability to obtain consent from parents/legal guardian and assent by minor subjects as applicable according to local regulations. * Agree to be available for all study visits including Visit 5 and follow-up Visit 6 and comply with follow-up on staff appointment reminders * Negative pregnancy test * Negative CT and GC nucleic acid amplification test (NAAT) at screening or positive CT or GC NAAT and receives standard of care (SOC according to CDC or World Health Organization \[WHO\] guidelines) treatment prior to enrollment with subsequent negative CT and GC NAAT testing at enrollment visit * Agree to use a woman-controlled method of contraception that is not directly delivered to the vaginal mucosa (with the exception of a vaginal ring) throughout the duration of the study, such as oral contraceptives, birth control implants, intrauterine devices (IUDs), or tubal ligation. Condom use only is not an acceptable form of contraception for this study * Able and willing to comply with all study procedures, including the use of eDiaries and reporting of all Adverse Events and concomitant medications. * Reports vaginal sexual intercourse with a male partner at least three times per month in the previous month and anticipates vaginal sexual intercourse regularly for the duration of the study * Agree to abstain from douching or any form of vaginal suppository use (other than investigational product) during course of study
Exclusion criteria
* In the opinion of the Investigator, has a history of substance or alcohol abuse in the last 12 months or, has issues, conditions, 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 * Women who have undergone a total hysterectomy (had uterus and cervix removed). However, women with subtotal hysterectomy with an intact cervix may be enrolled * Has a history or expectation of noncompliance with medications or intervention protocol * Has engaged in sexual vaginal intercourse or douching, or used of any form of vaginal suppository or intravaginal device (with the exception of contraceptive vaginal ring or tampons) for 24 hours prior to enrollment (may be enrolled at a later date if all other criteria are met) * Menstruating at enrollment (may be enrolled at a later date if all other criteria are met) * Is currently being treated, or has been treated, for a period of 21 days prior to enrollment, with any prohibited antibiotics. The prohibited antibiotics include azithromycin, erythromycin, doxycycline, levofloxacin, ofloxacin, ceftriaxone, and cefixime. * In the opinion of the Investigator, has signs/symptoms that indicate persistence of CT or GC infection diagnosed at screening, new interval infection, and/or a failure to comply with or complete the prescribed treatment regimen following a positive screening NAAT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Study Successes in the EVO100 and Placebo Treatment Groups | 16 weeks | Percentage of subjects who are defined study successes among the intervention groups with success defined as subjects completing the trial to Visit 5 without any CT or GC infection and no usage of prohibited antibiotics during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Safety of EVO100: AEs | 16 weeks | Descriptive analysis of AEs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EVO100 Gel EVO100 vaginal gel, 5 g
EVO100: EVO100 vaginal gel | 943 |
| Placebo Gel Placebo vaginal gel, 5 g
Placebo: Placebo vaginal gel | 949 |
| Total | 1,892 |
Baseline characteristics
| Characteristic | EVO100 Gel | Total | Placebo Gel |
|---|---|---|---|
| Age, Continuous | 29.5 years STANDARD_DEVIATION 10.31 | 29.6 years STANDARD_DEVIATION 10.4 | 29.7 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 467 Participants | 914 Participants | 447 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 461 Participants | 943 Participants | 482 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 35 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 22 Participants | 46 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 243 Participants | 496 Participants | 253 Participants |
| Race (NIH/OMB) More than one race | 35 Participants | 62 Participants | 27 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants | 42 Participants | 19 Participants |
| Race (NIH/OMB) White | 608 Participants | 1223 Participants | 615 Participants |
| Region of Enrollment United States | 943 participants | 1892 participants | 949 participants |
| Sex: Female, Male Female | 943 Participants | 1892 Participants | 949 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 926 | 0 / 937 |
| other Total, other adverse events | 39 / 926 | 28 / 937 |
| serious Total, serious adverse events | 4 / 926 | 9 / 937 |
Outcome results
Primary
Percentage of Study Successes in the EVO100 and Placebo Treatment Groups
Percentage of subjects who are defined study successes among the intervention groups with success defined as subjects completing the trial to Visit 5 without any CT or GC infection and no usage of prohibited antibiotics during the study.
Time frame: 16 weeks
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVO100 Gel | Percentage of Study Successes in the EVO100 and Placebo Treatment Groups | 684 Participants |
| Placebo Gel | Percentage of Study Successes in the EVO100 and Placebo Treatment Groups | 696 Participants |
Secondary
Evaluate Safety of EVO100: AEs
Descriptive analysis of AEs
Time frame: 16 weeks
Population: Safety
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EVO100 Gel | Evaluate Safety of EVO100: AEs | Serious TEAEs | 4 participants |
| EVO100 Gel | Evaluate Safety of EVO100: AEs | SAEs | 2 participants |
| EVO100 Gel | Evaluate Safety of EVO100: AEs | Treatment related AEs | 81 participants |
| EVO100 Gel | Evaluate Safety of EVO100: AEs | Deaths | 0 participants |
| Placebo Gel | Evaluate Safety of EVO100: AEs | Deaths | 0 participants |
| Placebo Gel | Evaluate Safety of EVO100: AEs | Serious TEAEs | 9 participants |
| Placebo Gel | Evaluate Safety of EVO100: AEs | Treatment related AEs | 62 participants |
| Placebo Gel | Evaluate Safety of EVO100: AEs | SAEs | 2 participants |