Status:
COMPLETED
A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
American College of Obstetricians and Gynecologists
Conditions:
Contraception
Bleeding
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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 s...
Detailed Description
The levonorgestrel intrauterine system (LNG-IUC) is one of the most effective, reversible methods of contraception currently available in the United States. User satisfaction is overall high , however...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00789802
Start Date
November 1 2008
End Date
January 1 2011
Last Update
March 20 2018
Active Locations (1)
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1
Washington University School fo Medicine
St Louis, Missouri, United States, 63110