Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
---|---|
Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00060463 |
This study will evaluate the effect of easy access to emergency contraceptive pills (ECPs) on the rates of pregnancy and sexually transmitted infections (STIs).
Condition | Intervention |
---|---|
Pregnancy Sexually Transmitted Diseases |
Behavioral: Increased access to emergency contraceptive pills |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Increased Access to Emergency Contraceptive Pills |
Estimated Enrollment: | 1490 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | October 2005 |
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 1,490 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.
Ages Eligible for Study: | 14 Years to 24 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
United States, Nevada | |
Planned Parenthood Mar Monte / University of California at San Francisco | |
Reno, Nevada, United States | |
United States, North Carolina | |
Planned Parenthood of Central North Carolina | |
Durham, North Carolina, United States |
Study ID Numbers: | 1R01HD39907 |
Study First Received: | May 6, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00060463 |
Health Authority: | United States: Federal Government |
Emergency contraceptive pills Pregnancy Sexually transmitted infection Chlamydia |
Gonorrhea Trichomonas Contraception |
Genital Diseases, Female Virus Diseases Sexually Transmitted Diseases Chlamydia Infections |
Emergencies Gonorrhea Genital Diseases, Male |
Disease Attributes Pathologic Processes Infection |