Clinical trial: Evaluation of the Efficacy, Safety, and Tolerability of LevoCept (NCT04457076)

Eligibility criteria:
Inclusion Criteria:

          1. Post-menarcheal, pre-menopausal females up to 45 years of age at the time of informed
             consent/assent and in good general health;

          2. History of regular menstrual cycles defined as occurring every 21-35 days when not
             using hormones or prior to recent pregnancy or spontaneous or induced abortion;

          3. Sexually active with a male partner who has not had a vasectomy nor other known
             fertility problems;

          4. Reasonably expect to have coitus at least once monthly during the study period;

          5. In a mutually monogamous relationship of at least 3 months duration at time of
             consent;

          6. Seeking to avoid pregnancy for the duration of the study;

          7. Willing to use the study drug as the sole form of contraception;

          8. Willing to accept a risk of pregnancy;

          9. Subjects must be in compliance with cervical cancer screening guidelines per the
             American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines without
             evidence of disease. Subjects who are age 21 to 24 y/o, at time of informed consent,
             must have a normal Papanicolaou test (Pap), atypical squamous cells of undetermined
             significance (ASC-US), or low-grade squamous intraepithelial lesion (LSIL). Subjects
             who are 25 or older at the time of informed consent must have a normal Pap test or an
             ASC-US result with a negative high-risk human papilloma virus (HPV) test result within
             the appropriate screen timeframe per ASCCP guidelines, and prior to the study IUD
             insertion. Alternatively, the subject must have had a colposcopy performed within the
             appropriate screen timeframe, and prior to the study IUD insertion that showed no
             evidence of dysplasia requiring treatment per ASCCP guidelines, or treatment was
             performed and follow-up at least 6 months after the treatment showed no evidence of
             disease by clinical evaluation;

         10. Able and willing to comply with all study tests, procedures, assessment tools
             (including e-diary) and follow-up;

         11. Able and willing to provide and document informed consent and Authorization for
             Release of Protected Health Information (PHI). Unemancipated subjects under 18 years
             old must provide assent and have written parental/legal guardian consent documented on
             the consent form consistent with local legal requirements;

         12. Plan to reside within a reasonable travel distance of a research site for the duration
             of the study.

         13. Subject agrees not to intentionally self-remove LevoCept

        Exclusion Criteria:

          1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse
             earlier in current cycle;

          2. Has had any procedure for or causing sterility (e.g. tubal ligation procedure);

          3. Subject who anticipates separation from her partner for more than a 6-month period
             during use of LevoCept;

          4. A previously inserted IUD/IUS that has not been removed by the time the study IUS is
             placed;

          5. History of previous IUD/IUS complications, such as perforation, expulsion, or
             pregnancy with IUD/IUS in place;

          6. Pain with current IUD/IUS;

          7. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months and
             has not had 2 normal menstrual cycles since the last injection;

          8. Subject is <4 weeks post-pregnancy (postpartum, spontaneous or induced abortion)

          9. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time
             during the 60 months of study participation;

         10. Exclusively breastfeeding before return of menses; lactating women will be excluded
             unless they have had 2 normal menstrual periods prior to enrollment;

         11. Unexplained abnormal uterine bleeding (suspicious for a serious condition), including
             bleeding 4 weeks post-septic abortion or puerperal sepsis;

         12. Severely heavy or painful menstrual bleeding;

         13. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically
             significant abnormal Pap test requiring evaluation or treatment;

         14. Any history of gestational trophoblastic disease with or without detectable elevated
             ß-human chorionic gonadotropin (ß-hCG) levels, or related malignant disease;

         15. Any congenital or acquired uterine anomaly that may complicate study drug placement,
             such as:

               -  Submucosal uterine leiomyoma

               -  Asherman's syndromes

               -  Pedunculated polyps

               -  Bicornuate uterus

               -  Didelphus or uterine septa

         16. Any distortions of the uterine cavity (e.g. fibroids), that, in the opinion of the
             investigator, are likely to cause issues during insertion, retention or removal of the
             IUS;

         17. 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 drug placement;

         18. Untreated or unresolved acute cervicitis or vaginitis;

         19. Known or suspected breast cancer or other progestin-sensitive cancer now or in the
             past;

         20. Known acute liver disease or liver tumor;

         21. Subjects who have an established immunodeficiency;

         22. Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;

         23. At high risk for sexually transmitted infections (e.g. multiple sexual partners);

         24. Known intolerance or allergy to any components of LevoCept, including intolerance or
             allergy to levonorgestrel, nickel, titanium, or silicone;

         25. Currently participating or planning future participation in a research study of an
             investigational drug or device during the course of this investigational study.
             Subject must have waited at least 30 days from exiting their last study prior to
             informed consent in this study;

         26. Subject has previously been enrolled in a VeraCept or LevoCept study (including the
             current study);

         27. Known or suspected alcohol or drug abuse within 12 months prior to the screening
             visit;

         28. Any general health, mental 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;

         29. Study staff or a member of the immediate family of study staff.
Female
Accepts Healthy Volunteers

Subject must be at most 45 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? 1