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:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT01664559
Eligibility Criteria:
Inclusion Criteria:
* Nulliparous and multiparous women ages 18-50, who are English or Spanish speaking, who present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).
Exclusion Criteria:
* Pregnancy
* Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
* If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs
* Misoprostol administration within 24 hours of enrollment
* History of prior IUD insertion
* Known allergy to NSAIDs including diagnosis of aspirin or NSAID induced asthma or urticaria
* Known contraindications to NSAIDs, such as the following medications that are risk category D (consider therapy modification) or X (avoid combination) including
* bile acid sequestrants (D - may decrease absorption of NSAIDs)
* cyclosporine (D - NSAIDs may enhance the nephrotoxic effects)
* drotrecogin alfa (D - NSAIDs may enhance the adverse/toxic effects, cause bleeding)
* floctafenine (X - may enhance adverse/toxic effect of NSAIDs)
* lithium (D - NSAIDs may decrease serum concentration)
* methotrexate (D - NSAIDs may decrease excretion)
* pentoxifylline (X - Ketorolac may enhance adverse/toxic effects)
* probenecid (X - may increase serum concentration of Ketorolac)
* rivaroxaban (D - Anti-platelet drugs may enhance anti-coagulation effect)
* SSRIs (D - may enhance the anti-platelet effect of NSAIDs, NSAIDs may diminish the therapeutic effect of SSRIs)
* warfarin (D - NSAIDs may enhance the anti-coagulation effect)
* Renal insufficiency (by history and/or chart review)
* Peptic ulcer disease or history of significant gastrointestinal bleeding
* Known thrombocytopenia, known coagulopathy, or known bleeding disorder
* Known contraindications to IUD
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01664559
Study Brief:
Protocol Section:
NCT01664559