The purpose of this study is to quantify the amount of menstrual bleeding in participants with menorrhagia and its correlation to the overall impact of health as measured by the Menorrhagia Questionnaire.
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Not applicable
Background summary
Excessive menstrual loss, or menorrhagia, is a major problem for many women
with significant impact on their medical, social, economic and psychological
well being. It is a condition that can be life-altering for women experiencing
anemia, fatigue and general limitations on their normal daily activities. With
a monthly blood loss of greater than 50 to 60 mL per cycle, most women
consuming an average Western diet will develop anemia. If left untreated, it
may be associated with subsequent morbidity including dysmenorrhea,
hospitalization, red blood cell transfusions and chronic pain. First line
treatment includes hormonal therapy and/or treatment with non-steroidal
anti-inflammatory drugs (NSAIDS). When these fail endometrial ablation can be
an effective minimally invasive surgical treatment.
In order to evaluate new technologies, particularly with the objective of
gaining regulatory approvals for marketing, patient outcomes need to be
quantified in terms of amount and duration of menstrual bleeding, overall
impact on health and patient satisfaction to allow objective comparisons
between pre-treatment and post-treatment.
The study planned in this protocol is intended to evaluate participants
believed by their physicians, based on participant self-identification, to have
significant menorrhagia, and its correlation to overall state of health as
measured on the Menorrhagia Questionnaire tool. Participants who are found to
require treatment for menorrhagia may be eligible for enrollment into a planned
follow-on investigational treatment protocol to evaluate the safety and
effectiveness of the AEGEA GEA System. No treatment will be offered as a part
of this protocol.
Study objective
The purpose of this study is to quantify the amount of menstrual bleeding in
participants with menorrhagia and its correlation to the overall impact of
health as measured by the Menorrhagia Questionnaire.
Study design
This study is:
• Prospective
• Multi-centered
• Single-arm (non-randomized)
• Data collection only
Study burden and risks
There is minimal risk associated with the needle stick for phlebotomy. Risks
are limited to hematoma and infection at the site of the needle stick. These
risks are minimized by using only staff skilled in phlebotomy.
prof. bronkhorstlaan 10 - bld 54
3723 MB BILTHOVEN
NL
prof. bronkhorstlaan 10 - bld 54
3723 MB BILTHOVEN
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37734.072.11 |