Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
NCT ID:
NCT01979861
Eligibility Criteria:
Inclusion Criteria:
* Female subject from (and including) age 30 to 50 years
* Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months
* Predictable cyclic menstrual cycles over past 6 months
* Excessive uterine bleeding
* Premenopausal at enrollment
* Normal PAP
* Normal endometrial biopsy
* Willing to use reliable contraception
* Not currently taking hormonal medication
* Agree to use sponsor provided catamenial product (sanitary pads/tampons)
Exclusion Criteria:
* Pregnant
* Desires future childbearing
* Presence of an IUD
* Previous endometrial ablation procedure
* Evidence of STI
* Evidence of PID
* Active infection of genitals, vagina, cervix, uterus or urinary tract
* Active endometritis
* Active bacteremia, sepsis or other active systemic infection
* Gynecologic malignancy
* Endometrial hyperplasia
* Known clotting defects or bleeding disorders
* On anticoagulant therapy
* Hemoglobin \<8gm/dl
* Prior uterine surgery
* Currently on medication that could thin myometrial muscle
* Severe dysmenorrhea, secondary to adenomyosis
* Abnormal uterine cavity
* Hydrosalpinx
* Uterine length \<6cm or \>12cm
* Currently in other clinical trial
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT01979861
Study Brief:
Protocol Section:
NCT01979861