ContraceptionPhase 4NCT00067509
Emergency Contraception (ECP): Reducing Unintended Pregnancies
A Phase 4 study testing emergency contraception (estrogen/progesterone) in people with Contraception and Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
Emergency contraception is a method of birth control that can be used up to three days after sexual intercourse. Emergency contraceptive pills (ECPs) can be given to a woman before she needs them (advance provision) or when she needs them (emergency provision). Read more about this study
- Who is it for?
- Ages 15 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Pregnancy
- What is being tested?
- emergency contraception (estrogen/progesterone)
- How many people
- 1,100 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2001to May 2004
- Phase
- Phase 4
- 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 15 to 39 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient at a participating clinic
Who cannot join
- Pregnant
- Medical or surgical procedure preventing pregnancy (e.g., tubal ligation, hysterectomy)
- Norplant or IUDs
- Desires to become pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Family Planning Council
Philadelphia, Pennsylvania, 19102
Family Health Council
Pittsburgh, Pennsylvania, 15222
About this study
Official title: A Second Chance With Emergency Contraception (ECP): Reducing Unintended Pregnancy
Emergency contraception is a method of birth control that can be used up to three days after sexual intercourse. Emergency contraceptive pills (ECPs) can be given to a woman before she needs them (advance provision) or when she needs them (emergency provision). This study will compare these two methods of providing ECPs.
Read the detailed description
ECPs can give women a "second chance" to prevent an unintended pregnancy that might arise because of lack or improper/defective use of contraceptives. By using ECP, a woman can reduce her risk of pregnancy by at least 75%; however, there is little information on what distribution patterns and other factors are most likely to encourage ECP use. This study will compare the use and cost of two ECP distribution patterns: advance provision and emergency provision. It will also identify environmental, situational, and behavioral factors associated with ECP acceptance and use.
Participants in this study will be recruited from four family planning clinics in the Philadelphia area and five family planning clinics in the Pittsburgh area. Participants from the Philadelphia clinics will be given ECPs as part of a regular clinic visit (advance provision); participants from the Pittsburgh clinics will be given ECPs on an emergency basis (emergent provision). Each participant will complete a short intake form and will be issued a pager. Participants will be paged every month over an 18-month period as a reminder to respond to a short automated telephone survey on ECP, contraceptives, and pregnancy status. Approximately half of the participants will be randomly selected to participate in in-depth interviews at study entry and Months 9 and 18. Clinic visit data will augment the surveys to verify use of the clinic and contraceptive method and to develop cost data.
- Conditions
- Contraception, Pregnancy
- Being tested
- emergency contraception (estrogen/progesterone)
- Keywords
- Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emergency contraception (estrogen/progesterone)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2003 (estimated)
- Study startJun 2001
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,100 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
- Investigators
- Paul G Whittaker, D.Phil., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067509
- Sponsor's protocol ID
- HD38515
- Status last verified
- Jul 2003
- First submitted
- 21 Aug 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
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
- A Second Chance With Emergency Contraception (ECP): Reducing Unintended Pregnancy
- ClinicalTrials.gov ID
- NCT00067509
- Acronym / sponsor ID
- HD38515
- Conditions
- Contraception, Pregnancy
- Keywords
- Female
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jun 2001
- Study completion
- May 2004
- First posted
- 25 Aug 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.
Emergency contraception is a method of birth control that can be used up to three days after sexual intercourse. Emergency contraceptive pills (ECPs) can be given to a woman before she needs them (advance provision) or when she needs them (emergency provision). This study will compare these two methods of providing ECPs.
Detailed description
ECPs can give women a "second chance" to prevent an unintended pregnancy that might arise because of lack or improper/defective use of contraceptives. By using ECP, a woman can reduce her risk of pregnancy by at least 75%; however, there is little information on what distribution patterns and other factors are most likely to encourage ECP use. This study will compare the use and cost of two ECP distribution patterns: advance provision and emergency provision. It will also identify environmental, situational, and behavioral factors associated with ECP acceptance and use.
Participants in this study will be recruited from four family planning clinics in the Philadelphia area and five family planning clinics in the Pittsburgh area. Participants from the Philadelphia clinics will be given ECPs as part of a regular clinic visit (advance provision); participants from the Pittsburgh clinics will be given ECPs on an emergency basis (emergent provision). Each participant will complete a short intake form and will be issued a pager. Participants will be paged every month over an 18-month period as a reminder to respond to a short automated telephone survey on ECP, contraceptives, and pregnancy status. Approximately half of the participants will be randomly selected to participate in in-depth interviews at study entry and Months 9 and 18. Clinic visit data will augment the surveys to verify use of the clinic and contraceptive method and to develop cost data.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patient at a participating clinic
Key exclusion criteria (4 listed)
- Pregnant
- Medical or surgical procedure preventing pregnancy (e.g., tubal ligation, hysterectomy)
- Norplant or IUDs
- Desires to become pregnant
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 |
|---|---|---|
| emergency contraception (estrogen/progesterone) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
Paul G Whittaker, D.Phil. principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing emergency contraception (estrogen/progesterone) in people with Contraception and Pregnancy, 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 1 inclusion and 4 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: finished, 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.