Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060463
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-05-06
Brief Title:
Increased Access to Emergency Contraceptive Pills
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:
Increased Access to Emergency Contraceptive Pills
Status:
UNKNOWN
Status Verified Date:
2004-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study will evaluate the effect of easy access to emergency contraceptive pills ECPs on the rates of pregnancy and sexually transmitted infections STIs
Detailed Description:
ECPs are a back-up contraceptive method indicated for prevention of pregnancy after sexual intercourse if a primary contraceptive method fails or is not used This trial will determine how increased access to ECPs affects the probability of pregnancy and three STIs The STIs tested in the study are chlamydia gonorrhea and trichomonas The trial will also evaluate how ready access to ECPs influences contraceptive or STI-prevention behaviors particularly use of ECPs themselves use of condoms and use of other contraceptive methods
The trial will be conducted among about 1490 young women in the United States at high risk for pregnancy and STIs Sexually active women aged 14 to 24 years who use barrier methods of contraception oral contraceptive pills or no contraception will be enrolled Each woman will be randomly assigned to either an Advance Provision group or a Standard Care group In the Advance Provision group women will be given a supply of ECPs free of charge to keep at home in case of need In the Standard Care group women will be counseled about ECPs and invited to come to the clinic to obtain them at usual clinic charges when necessary
Participants will be seen for follow-up at Months 6 and 12 At each visit participants will be asked about pregnancies STIs sexual activity self-assessed STI and pregnancy risk and use of ECPs and other contraceptive methods A specimen will be obtained for chlamydia gonorrhea and trichomonas testing
The trial will be conducted among about 1490 young women in the United States at high risk for pregnancy and STIs Sexually active women aged 14 to 24 years who use barrier methods of contraception oral contraceptive pills or no contraception will be enrolled Each woman will be randomly assigned to either an Advance Provision group or a Standard Care group In the Advance Provision group women will be given a supply of ECPs free of charge to keep at home in case of need In the Standard Care group women will be counseled about ECPs and invited to come to the clinic to obtain them at usual clinic charges when necessary
Participants will be seen for follow-up at Months 6 and 12 At each visit participants will be asked about pregnancies STIs sexual activity self-assessed STI and pregnancy risk and use of ECPs and other contraceptive methods A specimen will be obtained for chlamydia gonorrhea and trichomonas testing
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