Contraception
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGAMPHORA
non-hormonal contraceptive vaginal gel
Sponsors
Parexel
Evofem Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single Arm, unblinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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 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. 4. At the time of enrollment, have a single male sex partner for ≥3 months. 5. Have a negative urine pregnancy test at enrollment. 6. 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: 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. 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. 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. 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. 7. Be willing to engage in at least three acts of heterosexual vaginal intercourse per cycle. 8. 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). 9. 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. 10. 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. 11. Agree not to participate in any other clinical studies during the course of the study. 12. Be capable and willing to give written informed consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events (AE) | 10 months | Incidence of AE to evaluate safety |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interventional 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.
AMPHORA: non-hormonal contraceptive vaginal gel | 1,384 |
| Total | 1,384 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 23 |
| Overall Study | Early terminations | 267 |
| Overall Study | Lost to Follow-up | 250 |
| Overall Study | Non-Compliance with Study Drug | 38 |
| Overall Study | No sexually active | 26 |
| Overall Study | Physician Decision | 22 |
| Overall Study | Pregnancy | 104 |
| Overall Study | Protocol Violation | 22 |
| Overall Study | Study method no longer primary method | 12 |
| Overall Study | Study Terminated by Sponsor | 1 |
| Overall Study | Withdrawal by Subject | 170 |
Baseline characteristics
| Characteristic | Interventional |
|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 4.49 |
| Body Mass Index (BMI) at Screening | 28.770 kg/m^2 STANDARD_DEVIATION 8.1079 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 571 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 805 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants |
| Race (NIH/OMB) Asian | 35 Participants |
| Race (NIH/OMB) Black or African American | 348 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 38 Participants |
| Race (NIH/OMB) White | 955 Participants |
| Sex: Female, Male Female | 1384 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,330 |
| other Total, other adverse events | 601 / 1,330 |
| serious Total, serious adverse events | 17 / 1,330 |
Outcome results
Primary
Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy
To evaluate the contraceptive efficacy of Amphora over 7-cycle of use
Time frame: 10 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional | Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy | 100 Participants |
Comparison: 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%95% CI: [9.91, 17.39]Kaplan-Meier
Secondary
Number of Subjects With Adverse Events (AE)
Incidence of AE to evaluate safety
Time frame: 10 months
Population: All subjects enrolled into the study and who administered the study drug at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional | Number of Subjects With Adverse Events (AE) | Subjects with greater than or equal to 1 SAE | 17 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | AE leading to early discontinuation | 25 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | Relationship of AEs: definitely related | 108 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | Relationship of AEs: not assessable | 2 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | Intensity of AEs: mild | 318 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | Intensity of AEs: moderate | 249 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | Intensity of AEs: severe | 31 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | Intensity of AEs: life-threatening | 3 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | Death | 0 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | Subjects with greater than or equal to 1 AE | 601 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | Relationship of AEs: unlikely to be Related | 186 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | Relationship of AEs: possibly related | 166 Participants |
| Interventional | Number of Subjects With Adverse Events (AE) | Relationship of AEs: probably related | 139 Participants |