Phase IIc (Protocol 55P127): Addition of up to 10 Women to Explore Silver Systemic Absorption as a Continuation Study to: Phase IIb (Protocol 55P140)
One of the AUB symptoms, heavy menstrual bleeding (HMB), can lead to iron deficiency and iron deficiency anemia and in acute and severe cases, can necessitate emergency medical care. This study's focus is on the symptom of HMB which has a number of benign causes. The investigative device, the IUB SEAD™, is a novel spherical endometrial ablation device developed to allow for simple, office-based chemical EA to treat benign causes of the symptom of HMB. The suggested procedure is expected to be simpler than the currently available EA methods and yet should still reduce the need for a hysterectomy.
• Female subject age 40 to 50 years, inclusive
• Suffering from the symptom of heavy menstrual bleeding (HMB) from benign causes with no definable organic cause and are candidates for endometrial ablation or surgical treatment.
• PBAC score of \>150 - an average of 2 consecutive screening scores prior to study treatment
• Are thought to be ovulatory with cyclic predictable onset of menses with a cycle length of 24-38 days.
• Have either a normal appearing endometrial cavity as assessed by hysteroscopy performed within 90 days of study treatment, or one that is distorted by a FIGO Type 2 submucous leiomyoma ≤3 cm in mean diameter.
• Have endometrial sampling with normal histology within 6 months of the study procedure.
• Premenopausal status confirmed by FSH level measurement at screening (FSH \< 40 IU/L). FSH level measurement will be repeated in case of a borderline result
• Screening hemoglobin levels \>9.0 g/dL
• Uterine sound measurement of 6.5-12 cm (external os to internal fundus)
⁃ Negative serum pregnancy test at the Screening visit and on the day of SEAD™ treatment
⁃ women whose sexual activity places them at risk for pregnancy must agree to use an effective, non-hormonal, non-intrauterine method of contraception throughout the course of the study. For this study, acceptable effective methods of contraception are considered to be those listed below:
∙ Barrier method, i.e., (a) condom (male or female) with spermicide or (b) diaphragm with spermicide or
‣ Vasectomy (partner), or
‣ Abstinence, if in line with the preferred and usual lifestyle of the subject \[where abstinence is defined as refraining from heterosexual intercourse\]
⁃ Subject is able to understand and sign a written informed consent form
⁃ Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
⁃ The subject demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram