Clinical trial: Evaluation of the Efficacy and Safety of LevoCept (NCT02882191)

Eligibility criteria:
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.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction