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:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT01695902
Eligibility Criteria:
Inclusion Criteria:
* Non-pregnant, non-planning pregnancy, non-lactating non-menopausal females at least 18 years of age.
* Patients with a clinical diagnosis of functional Menorrhagia during the last 6 months.
* Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them.
Exclusion Criteria:
* History of endometrial ablation or dilatation and/or curettage within the 3 months prior to screening
* Copper - coiled-intrauterine device or LNG releasing IUS use within 2 months prior to screening
* Abnormal liver function or jaundice
* Renal insufficiency
* Other hormonal treatment (sexual steroids),
* Organic causes of abnormal uterine bleeding (presence of endometrial polyps, submucous myomas of any size, or myometrial myomas \> than 3 cm, adenomyosis, atypical hyperplasia, carcinoma)
* Abnormal uterine morphology
* Presence of ovarian cyst \> 3 cm
* Lower genital tract infection
* Current or recurrent PID (present or recurrent pelvis infection (including history of postpartum endometritis, infected miscarriage) during the past 3 months
* Uncontrolled hypertension
* Congenital or acquired valvular disease (including corrections with prosthetic valves)
* Known or suspected pregnancy
* Known or suspected hormone-dependent tumor
* BMI \> 30
* Abnormal Pap smear test or other evidence of cervical/endometrial mancy
* Unexplained amenorrhea
* Known hypersensitivity to device material and/or Levonorgestrel
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01695902
Study Brief:
Protocol Section:
NCT01695902