PregnancyNCT00520455
Randomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
A study testing levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms in people with Pregnancy, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this trial is to determine whether providing non-contracepting women with gonorrhea or chlamydial infection with advanced provision emergency contraception (APEC) and condoms decreases their risk of becoming pregnant. Read more about this study
- Who is it for?
- Ages 16 to 60 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jun 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 16 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Non-contracepting women >15 years of age who were reported to Public Health Seattle \& King County with a diagnosis for gonorrhea or chlamydial infection and who were interviewed by public health staff for purposes of partner notification
Who cannot join
- Use of effective contraception (hormonal contraception, IUD, diaphragm); sex with only one partner in the preceding 60 days who was status post vasectomy; age <15; inability to speak English; history of tubal ligation, hysterectomy, or menopause.
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health - Seattle & King County STD Clinic
Seattle, Washington, 98104
About this study
Official title: Randomized Controlled Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
The purpose of this trial is to determine whether providing non-contracepting women with gonorrhea or chlamydial infection with advanced provision emergency contraception (APEC) and condoms decreases their risk of becoming pregnant.
- Conditions
- Pregnancy
- Being tested
- levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condomsDrug
Also called Plan B
levonorgestrel 0.75mg taken twice 12 hours apart (Plan B). Study subjects to take medication after unprotected vaginal intercourse
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control participants were advised where they could obtain hormonal contraception on a sliding scale basis. Participants were also advised where they could obtain hormonal contraception on a sliding scale basis. |
| Intervention | Experimental | Study subjects were prescribed levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and a package of 30 condoms provided via a commerical pharmacy at no cost to the study subject. The subject could refill this prescription as many times as they wanted for 12 months Receives: Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Measured: 1 year - measured via interview every 3 months
Secondary outcomes (3)
Abortion
Measured: 1 year - measured via interview every 3 months
Condom use
Measured: Measured every 3 months for one year
Use of hormonal contraception
Measured: Measured via interview every 3 months for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startJan 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Matthew R Golden, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520455
- Sponsor's protocol ID
- 037249C
- Status last verified
- Nov 2007
- First submitted
- 22 Aug 2007
- Last updated
- 15 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
- ClinicalTrials.gov ID
- NCT00520455
- Acronym / sponsor ID
- 037249C
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jan 2004
- Study completion
- Jun 2005 (actual)
- First posted
- 24 Aug 2007 (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.
The purpose of this trial is to determine whether providing non-contracepting women with gonorrhea or chlamydial infection with advanced provision emergency contraception (APEC) and condoms decreases their risk of becoming pregnant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control participants were advised where they could obtain hormonal contraception on a sliding scale basis. Participants were also advised where they could obtain hormonal contraception on a sliding scale basis. |
| Intervention | Experimental | Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condomsStudy subjects were prescribed levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and a package of 30 condoms provided via a commerical pharmacy at no cost to the study subject. The subject could refill this prescription as many times as they wanted for 12 months |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Non-contracepting women >15 years of age who were reported to Public Health Seattle \& King County with a diagnosis for gonorrhea or chlamydial infection and who were interviewed by public health staff for purposes of partner notification
Key exclusion criteria (1 listed)
- Use of effective contraception (hormonal contraception, IUD, diaphragm); sex with only one partner in the preceding 60 days who was status post vasectomy; age <15; inability to speak English; history of tubal ligation, hysterectomy, or menopause.
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 |
|---|---|---|
| levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condomsAlso: Plan Blevonorgestrel 0.75mg taken twice 12 hours apart (Plan B). Study subjects to take medication after unprotected vaginal intercourse | Drug | Intervention |
Primary outcome
Pregnancy
Time frame: 1 year - measured via interview every 3 months
3 secondary outcomes
Abortion
Time frame: 1 year - measured via interview every 3 months
Condom use
Time frame: Measured every 3 months for one year
Use of hormonal contraception
Time frame: Measured via interview every 3 months for one year
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 15 Nov 2007.
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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.
Matthew R Golden, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms in people with Pregnancy, run by University of Washington at 1 site 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 1 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 15 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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.
What does the primary outcome measure?
Pregnancy (time frame: 1 year - measured via interview every 3 months). It is what the study was designed to measure, not a finding.
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 15 Nov 2007.