PregnancyNCT00060463
Increased Access to Emergency Contraceptive Pills
A study testing Increased access to emergency contraceptive pills in people with Pregnancy and Sexually Transmitted Diseases, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Sexually Transmitted Diseases
- What is being tested?
- Increased access to emergency contraceptive pills
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 1,490 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2002to Oct 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood of Central North Carolina
Durham, North Carolina
Planned Parenthood Mar Monte / University of California at San Francisco
Reno, Nevada
About this study
This study will evaluate the effect of easy access to emergency contraceptive pills (ECPs) on the rates of pregnancy and sexually transmitted infections (STIs).
Read the 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.
- Conditions
- Pregnancy, Sexually Transmitted Diseases
- Being tested
- Increased access to emergency contraceptive pills
- Keywords
- Emergency contraceptive pills, Pregnancy, Sexually transmitted infection, Chlamydia, Gonorrhea, Trichomonas, Contraception
- Medical subject headings
- Sexually Transmitted Diseases, Chlamydia Infections, Gonorrhea, Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased access to emergency contraceptive pillsBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startOct 2002
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,490 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060463
- Sponsor's protocol ID
- 1R01HD039907
- Status last verified
- Oct 2004
- First submitted
- 6 May 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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.
PubMed 19104366Raymond 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.
PubMed 17077230
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Access to Emergency Contraceptive Pills
- ClinicalTrials.gov ID
- NCT00060463
- Acronym / sponsor ID
- 1R01HD039907
- Conditions
- Pregnancy, Sexually Transmitted Diseases
- Keywords
- Emergency contraceptive pills, Pregnancy, Sexually transmitted infection, Chlamydia, Gonorrhea, Trichomonas, Contraception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,490 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Oct 2002
- Study completion
- Oct 2005
- First posted
- 7 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increased access to emergency contraceptive pills | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Derived from this study: PubMed 19104366Weaver 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.
- Derived from this study: PubMed 17077230Raymond 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased access to emergency contraceptive pills in people with Pregnancy and Sexually Transmitted Diseases, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00060463, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005; AzTrials last refreshed its copy on 31 Oct 2026.