Clinical trial: A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC (NCT00789802)

Eligibility criteria:
Inclusion Criteria:

          -  Must be of reproductive age from 18 to 45 years

          -  Must be choosing LNG-IUC for contraception

          -  Must be English-speaking

          -  Be willing to avoid additional use of exogenous hormones, such as oral contraceptives,
             for the duration of the study

          -  Be willing to avoid additional use of nonsteroidal antiinflammatory drugs, such as
             ibuprofen or aspirin for the duration of the study

          -  Be willing to comply with the study protocol, keep the bleeding diary and comply with
             follow-up visits and telephone interviews as scheduled

          -  Be willing and able to provide informed consent

        Exclusion Criteria:

          -  Known or suspected pregnancy

          -  Contraindication to estrogen use, such as presence or history of:

               -  venous thromboembolism

               -  Arterial thrombosis

               -  Thrombophilia disorders, or known family history of

               -  Hypertension

               -  Migraine headaches with aura or focal neurologic involvement, or any migraine
                  over age 35 years

          -  Recent or planned future major surgery which will result in prolonged immobilization
             during the study period

          -  Presence or history of severe hepatic disease or liver tumors

          -  Known or suspected estrogen-dependent neoplasm

          -  Vaginal bleeding of unknown etiology

          -  Any cigarette smoking and age over 35 years

          -  Contraindications to nonsteroidal anti-inflammatory use, such as presence or history
             of:

               -  Gastrointestinal ulcer disease

               -  Renal insufficiency or failure

               -  Aspirin-induced asthma or hypersensitivity reaction

               -  Systemic lupus erythematosus (SLE) and mixed connective tissue disorders

               -  Use of anticoagulants

               -  Cardiovascular disease

          -  Use of medications that alter estrogen metabolism, i.e. rifampin, certain anti-seizure
             medications

          -  Regular use of an NSAID

          -  Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or
             endometrial polyp

          -  Hypersensitivity or allergy to any of the components of the estradiol patch

          -  Use of injectable contraception within 6 months of the start of the study medication

          -  Delivery or abortion in the previous 4 weeks

          -  Prior use of LNG-IUD

          -  Any condition, that in the opinion of the investigator, would contraindicate study
             participation
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? 1