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Increased Access to Emergency Contraceptive Pills

Primary Purpose

Pregnancy, Sexually Transmitted Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Increased access to emergency contraceptive pills
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Emergency contraceptive pills, Pregnancy, Sexually transmitted infection, Chlamydia, Gonorrhea, Trichomonas, Contraception

Eligibility Criteria

14 Years - 24 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Planned Parenthood Mar Monte / University of California at San Francisco
  • Planned Parenthood of Central North Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00060463
Brief Title
Increased Access to Emergency Contraceptive Pills
Official Title
Increased Access to Emergency Contraceptive Pills
Study Type
Interventional

2. Study Status

Record Verification Date
October 2004
Overall Recruitment Status
Unknown status
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Sexually Transmitted Diseases
Keywords
Emergency contraceptive pills, Pregnancy, Sexually transmitted infection, Chlamydia, Gonorrhea, Trichomonas, Contraception

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1490 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Increased access to emergency contraceptive pills

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Planned Parenthood Mar Monte / University of California at San Francisco
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Planned Parenthood of Central North Carolina
City
Durham
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19104366
Citation
Weaver MA, Raymond EG, Baecher L. Attitude and behavior effects in a randomized trial of increased access to emergency contraception. Obstet Gynecol. 2009 Jan;113(1):107-116. doi: 10.1097/AOG.0b013e318190c0fe.
Results Reference
derived
PubMed Identifier
17077230
Citation
Raymond EG, Stewart F, Weaver M, Monteith C, Van Der Pol B. Impact of increased access to emergency contraceptive pills: a randomized controlled trial. Obstet Gynecol. 2006 Nov;108(5):1098-106. doi: 10.1097/01.AOG.0000235708.91572.db.
Results Reference
derived

Learn more about this trial

Increased Access to Emergency Contraceptive Pills

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