Increased Access to Emergency Contraceptive Pills

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Overall Status

Unknown status

CT.gov ID

NCT00060463

Collaborator

(none)

1,490

Enrollment

Locations

Duration (Months)

745

Patients Per Site

20.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Sexually Transmitted Diseases	Behavioral: Increased access to emergency contraceptive pills	N/A

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 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Increased Access to Emergency Contraceptive Pills

Study Start Date :

Oct 1, 2002

Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 24 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

Sexual intercourse with a male partner at least twice in the month prior to study entry
Does not desire pregnancy within 1 year of study entry
6 weeks since the end of her last pregnancy and has had at least one menstrual period since resolution of her last pregnancy
Literate in English or Spanish

Exclusion Criteria

Surgically sterilized or intends to become sterilized within 1 year of study entry
Intrauterine device or a hormonal implant in place or intends to have one inserted within 1 year of study entry
Received an injection of a long-term contraceptive hormone (such as depot-medroxyprogesterone acetate) within 6 months of study entry or intends to receive one within 1 year of study entry
Intends to use Lunelle, the vaginal contraceptive ring, or the contraceptive patch for contraception within 1 year of study entry
Intends to use partners' vasectomy as her method of contraception within 1 year of study entry
Pregnant or breastfeeding
Known or suspected infertility
Previously participated in this study
Planning to move out of the study area within 1 year of study entry
Currently participating in another research study that would interfere with the conduct of this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Planned Parenthood Mar Monte / University of California at San Francisco	Reno	Nevada	United States
2	Planned Parenthood of Central North Carolina	Durham	North Carolina	United States