Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243815
Status:
COMPLETED
Last Update Posted:
2006-10-17
First Post:
2005-10-24
Brief Title:
Use of Ibuprofen to Prevent IUD Site Effects
Sponsor:
FHI 360
Organization:
FHI 360
Study Overview
Official Title:
Prophylactic Ibuprofen Effect on IUD Continuation Rates
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research will determine whether prophylactic use of ibuprofen can prevent common side effects of the copper intrauterine device IUD and prevent early removal of the device
Detailed Description:
Increased menstrual bleeding and pain are the primary side effects that lead to early removal of the copper intrauterine device IUD Ibuprofen and other nonsteroidal anti-inflammatory drugs are a proven treatment for such IUD-induced problems This study will determine if prophylactic use of ibuprofen can improve continuation rates of the IUD
A total of 2019 first-time IUD users were recruited in Chile for this double-blind randomized placebo-controlled trial Half of the participants were given ibuprofen and instructions to take 1200 mg daily during menses for up to 5 days each cycle for the first six months of IUD use The other half were asked to take an identical-appearing placebo in the same manner The primary study endpoint was IUD removal within 12 months of insertion
A total of 2019 first-time IUD users were recruited in Chile for this double-blind randomized placebo-controlled trial Half of the participants were given ibuprofen and instructions to take 1200 mg daily during menses for up to 5 days each cycle for the first six months of IUD use The other half were asked to take an identical-appearing placebo in the same manner The primary study endpoint was IUD removal within 12 months of insertion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None