Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091728
Status:
TERMINATED
Last Update Posted:
2005-11-07
First Post:
2004-09-16
Brief Title:
Hormonal Contraception and Risk of Chlamydia and Gonorrhea
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Hormonal Contraception Cervical Ectopy and STDs
Status:
TERMINATED
Status Verified Date:
2004-09
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:
There are biological reasons to suspect that hormones may affect the risk of a woman becoming infected with a sexually transmitted disease The evidence on this issue to date is mixed and previous studies have methodologic flaws making it difficult to draw conclusions about the results
This study compares the risk of developing either Chlamydial or Gonorrheal infection among three groups of women those using combined oral contraceptives birth control pills those using the injectable hormone brand name Depo Provera and those women using non-hormonal contraceptive methods
This study compares the risk of developing either Chlamydial or Gonorrheal infection among three groups of women those using combined oral contraceptives birth control pills those using the injectable hormone brand name Depo Provera and those women using non-hormonal contraceptive methods
Detailed Description:
The study was designed to examine the relationship between hormonal contraceptive use and possible increased risk of Chlamydial and Gonococcal sexually transmitted infections and to determine if any increased risk appeared to be mediated by the extent of cervical ectopy
Eight hundred and nineteen women ages 15 to 45 years were recruited from an inner city clinic and from a nearby suburban clinic The women were classified into three groups based on type of contraceptive used One group used oral contraceptives the second used injectable depo-medroxyprogesterone acetate DMPA and the third group used non-hormonal contraceptive methods Women from each group were followed at 3 6 and 12 months after enrollment to determine if a new infection with Chlamydia or Gonorrhea had occurred and to evaluate the extent of cervical ectopy present
Eight hundred and nineteen women ages 15 to 45 years were recruited from an inner city clinic and from a nearby suburban clinic The women were classified into three groups based on type of contraceptive used One group used oral contraceptives the second used injectable depo-medroxyprogesterone acetate DMPA and the third group used non-hormonal contraceptive methods Women from each group were followed at 3 6 and 12 months after enrollment to determine if a new infection with Chlamydia or Gonorrhea had occurred and to evaluate the extent of cervical ectopy present
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