A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo. The objective of this study is to compare the total number of days of bleeding experienced by first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared to those randomized to placebo for the first 12 weeks of use. We will enroll women initiating LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo. We will enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for 16 weeks which will be used to calculate the total number of bleeding or spotting days. Statistical analysis will be performed to evaluate if there is less bleeding among the treatment arms then the placebo arm.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: American College of Obstetricians and Gynecologists
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Naproxen; Polyestradiol phosphate

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