| Eligibility |
Inclusion Criteria:
1. Between 18-40 years of age at the time of study initiation; 1.1 Enrollment will be
targeted for 225 subjects aged 18-35 (for safety and effectiveness analyses) and an
additional 25 subjects aged 36-40 (for safety only) (note: all subjects will be
included in the analysis for device placement and tolerability);
2. Pre-menopausal, as determined by regular menstrual cycle (28 ± 7 days) for the last 3
months; 2.1 Based on patient history, when not on hormonal contraceptives;
3. Sexually active with a male partner who has not had a vasectomy;
4. Reasonably expected to have to coitus at least once monthly during the study period.
5. In a mutually monogamous relationship of at least 3-6 months duration;
6. Seeking to avoid pregnancy for the next 12 months;
7. Willing to use the study device as the sole form of contraception;
8. Willing to accept a risk of pregnancy;
9. Normal PAP or ASC-US with negative high risk HPV test result within the appropriate
screen timeframe, and prior to LevoCept insertion;
10. Able and willing to comply with all study tests, procedures, assessment tools and
follow-up; and
11. Able and willing to provide and document informed consent and Authorization for
Release of Protected Health Information (PHI).
Exclusion Criteria:
1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse
earlier in current cycle
2. Subject who anticipates separation from her partner for more than 1 cycle within the
next 12 months;
3. A previously inserted IUD that has not been removed by the time LevoCept is placed;
4. History of previous IUD complications, such as perforation, expulsion, infection
(pelvic inflammatory disease) or pregnancy with IUD in place.;
5. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months;
5.1 Must have had 2 normal menstrual cycles since the last injection;
6. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time
during the 12 months of study participation;
7. Postpartum, prior to a minimum of 6 weeks and complete uterine involution;
8. Exclusively breastfeeding before return of menses; Lactating women will be excluded
unless they have had have had two normal menstrual periods prior to enrollment.
8.1 Must have had 2 normal spontaneous menstrual cycles since delivery
9. Unexplained abnormal uterine bleeding (suspicious for serious condition), before
evaluation; Immediately post-septic abortion or puerperal sepsis;
10. Severely heavy or painful menstrual bleeding;
11. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically
significant abnormal pap smear requiring evaluation or treatment.
12. Any history of gestational trophoblastic disease with or without detectable elevated
ß-hCG levels, or related malignant disease without an intervening normal pregnancy;
13. Any congenital or acquired uterine anomaly that may complicate IUD placement, such as:
13.1 Submucosal uterine leiomyoma 13.2 Asherman's syndrome 13.3 Pedunculated polyps
13.4 Bicornuate uterus 13.5 Didelphus or uterine septa
14. Any distortions of the uterine cavity (e.g. fibroids), in the opinion of the
investigator, likely to cause issues during insertion, retention or removal of the
IUD;
15. Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior
trachelectomy or extensive conization that, in the opinion of the investigator would
prevent cervical dilation and study device placement;
16. Current or recent (within the last 3 months) untreated acute cervicitis or vaginitis;
17. Known or suspected breast cancer or other progestin-sensitive cancer now or in the
past;
18. Known acute liver disease or liver tumor;
19. Subjects who have an established immunodeficiency;
20. High risk for STDs (e.g., multiple sexual partners);
21. Known or suspected HIV infection or clinical AIDS;
22. Known intolerance or allergy to any component of the LevoCept system; including
nickel, silicone or tantalum;
23. Subject had LevoCept placed previously or had 2 attempts at placement;
24. Known or suspected alcohol or drug abuse within 12 months prior to the screening
visit;
25. Any general health or behavioral condition that, in the opinion of the Investigator,
could represent an increased risk for the subject or would render the subject less
likely to provide the needed study information.
26. Subject is currently participating or has participated in another clinical study
involving another investigational agent within 30 days of the planned LevoCept
insertion date or is planning participation in another clinical trial with an
investigational agent within 52 weeks (visit 6) after insertion.
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