Clinical trial: Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding (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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years.

Patient description (patient's own words): I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL.

Does the patient match the trial criteria? Entailment