excessive uterine bleeding menorrhagia
Conditions
Interventions
None listed
Sponsors
Factory, CRO for medical devices
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Due to the nature of the study, only women will be enrolled in this study. Candidates for this study must meet ALL of the following criteria: a) Women of age 30-50 years b) Pre-menopausal c) History of excessive uterine bleeding defined by: • Heavy menstrual bleeding as noted by flooding or interfering with work or social activities • Previously failed, did not tolerate or refused medical therapy (oral contraceptive pills, NSAIDs, failed D&C or cyclic progestin therapy) d) Evidence of normal PAP smear within the last 6 months, if available e) Normal endometrial biopsy results within the last 6 months, if available f) Is not using hormonal contraception and agrees to not use hormonal contraception for study duration g) Does not desire current or future childbearing h) Does not desire to have an intrauterine device (IUD) placed or Essure or Adiana devices placed while participating in this study i) Able and willing to comply with all study tests, procedures and assessment tools j) Able and willing to sign the Informed Consent Form; k) Agrees to follow up period as outlined, and use of sponsor provided sanitary pads and tampons
Exclusion criteria
Exclusion criteria: Candidates will be excluded if ANY of the following conditions apply: a) Desires treatment for menorrhagia within the next 2 months b) Hemoglobin 1 cm in diameter i) Intramural fibroids that are > 4 cm in diameter j) Septate uterus k) Known or suspected hydrosalpinx l) Previous endometrial ablation procedure m) Desire for complete amenorrhea, once treatment is sought n) Known anatomical condition (e.g., history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g., long term medical therapy) that could lead to weakening of the myometrium. o) Currently pregnant p) Desire for future fertility q) Current use of any Intrauterine Device (IUD), Essure, Adiana, or similar device or desire for placement before completion of the study r) Current use of hormonal contraception or use of endometrial suppression therapy within three month of AH screening s) The investigator determines enrollment in the study is not appropriate for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The purpose of this study is to evaluate the amount of menstrual bleeding in patients with menorrhagia and its correlation to the overall impact of health as measured by the Alkaline Hematin test and Menorrhagia Questionnaire. As part of the evaluation, participants will be screened for anemia as an indicator of the amount of blood loss experienced and reported. | — |
Countries
Netherlands
Outcome results
None listed