Status:
COMPLETED
AMP002 Phase III Contraceptive Study
Lead Sponsor:
Evofem Inc.
Collaborating Sponsors:
Parexel
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- To enroll in the clinical study, potential subjects must:
- Be healthy women, who are sexually active, at risk of pregnancy, and desiring contraception.
- Be within the age range of 18 to 35 years old (inclusive) at enrollment.
- 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.
- At the time of enrollment, have a single male sex partner for ≥3 months.
- Have a negative urine pregnancy test at enrollment.
- 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:
- 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.
- 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.
- If a contraceptive implant was recently removed, the subject must have had at least two consecutive, spontaneous menses prior to the date of consent.
- 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.
- Be willing to engage in at least three acts of heterosexual vaginal intercourse per cycle.
- 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).
- 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.
- 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.
- Agree not to participate in any other clinical studies during the course of the study.
- Be capable and willing to give written informed consent to participate in the study.
Exclusion
Key Trial Info
Start Date :
July 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2018
Estimated Enrollment :
1384 Patients enrolled
Trial Details
Trial ID
NCT03243305
Start Date
July 24 2017
End Date
November 29 2018
Last Update
September 17 2020
Active Locations (87)
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1
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
2
East Valley Family Physicians 137
Chandler, Arizona, United States, 85224
3
Mesa Obstetricians & Gynecologists 184
Mesa, Arizona, United States, 85209
4
Family Practice Specialists Ltd 170
Phoenix, Arizona, United States, 85018