Evaluation of Menstrual Bleeding in Women with Menorrhagia Significant Enough to Seek Treatment

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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

Candidates will be excluded if ANY of the following conditions apply:
a) Desires treatment for menorrhagia within the next 2 months
b) Hemoglobin <8gm/dl or considered by the investigator at risk for requiring blood transfusion within 12 months
c) Known active pelvic inflammatory disease or genital tract infection (cervicitis, vaginitis, endometritis), or active urinary tract infection
d) Clotting defects or bleeding disorders (based on history) or on anti-coagulant therapy
e) Abnormal PAP smear
f) Malignant pathology, documented or suspected, based on endometrial biopsy
g) History of gynecologic malignancy within the past 5 years
h) Uterine and/or cervical polyps > 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The purpose of this study is to evaluate the amount of menstrual bleeding in<br /><br>patients with menorrhagia and its correlation to the overall impact of health<br /><br>as measured by the Alkaline Hematin test and Menorrhagia Questionnaire. As part<br /><br>of the evaluation, participants will be screened for anemia as an indicator of<br /><br>the amount of blood loss experienced and reported.</p><br>

Secondary Outcome Measures