Increased Access to Emergency Contraceptive Pills

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2004 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00060463
First received: May 6, 2003
Last updated: June 23, 2005
Last verified: October 2004
  Purpose

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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Increased Access to Emergency Contraceptive Pills

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 1490
Study Start Date: October 2002
Estimated Study Completion Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   14 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060463

Locations
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
Sponsors and Collaborators
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00060463     History of Changes
Other Study ID Numbers: 1R01HD39907
Study First Received: May 6, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Emergency contraceptive pills
Pregnancy
Sexually transmitted infection
Chlamydia
Gonorrhea
Trichomonas
Contraception

Additional relevant MeSH terms:
Emergencies
Sexually Transmitted Diseases
Disease Attributes
Pathologic Processes
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Postcoital
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 18, 2014