ContraceptionPhase 3NCT00551616
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
A Phase 3 study testing CDB-2914 and Levonorgestrel in people with Contraception, run by HRA Pharma at 33 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- CDB-2914 and Levonorgestrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,221 participants
- Where
- 33 sitesin 3 countries
- Study dates
- Apr 2007to Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US
- present within 120 hours of unprotected intercourse
- regular menstrual cycles
- No current use of hormonal contraception
- Willing to not use hormonal methods of contraception until study completion
- At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion
Show all 9Show fewer
- For women who present more than 72 hours after intercourse, decline the insertion of an Intra Uterine Device for emergency contraception
- Able to provide informed consent
- Willing to abstain from further acts of unprotected intercourse until study completion
Who cannot join
- One or more acts of unprotected intercourse more than 120 hours
- current or recent use of hormonal methods of contraception
- currently pregnant or breastfeeding
- tubal ligation or current use of IUD
- Use of hormonal emergency contraception since last menstrual period
- Current use of IUD
Show all 11Show fewer
- Tubal ligation
- Partner with a vasectomy
- Unsure about the date of the last menstrual period
- Severe asthma insufficiently controlled by oral glucocorticoid
- Hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study
Trial locations and contacts
33 sites in 3 countries.
33 sites in 3 countries
United States23 sites
Planned Parenthood of Northeast Ohio Akron Health Center
Akron, Ohio
Planned Parenthood of Texas Capitol Region
Austin, Texas
Planned Parenthood of Northeast Ohio Bedford Health Center
Bedford, Ohio
Planned Parenthood of the Rocky Mountains
Boulder, Colorado
Planned Parenthood of Northeast Ohio East Cleveland Health Center
Cleveland, Ohio
Planned Parenthood of Northeast Ohio Old Brooklyn Health Center
Cleveland, Ohio
Planned Parenthood of the Rocky Mountains
Denver, Colorado
Fannin Health Center
Houston, Texas
Planned Parenthood of Houston and Southeast Texas Research Department
Houston, Texas
Planned Parenthood of Northeast Ohio Kent Health Center
Kent, Ohio
Planned Parenthood of Greater Miami
Lake Worth, Florida
Planned Parenthood of the Rocky Mountains
Littleton, Colorado
Planned Parenthood Hollywood
Los Angeles, California
Planned Parenthood of Greater Miami
Miami, Florida
Planned Parenthood of Greater Miami
North Miami, Florida
Planned Parenthood Association of Utah
Ogden, Utah
Planned Parenthood Association of Utah
Orem, Utah
Planned Parenthood of Northeast Ohio Rocky River Health Center
Rocky River, Ohio
Planned Parenthood Association of Utah
Salt Lake City, Utah
Planned Parenthood Santa Monica
Santa Monica, California
Planned Parenthood of Greater Miami
Stuart, Florida
Planned Parenthood of Greater Miami
West Palm Beach, Florida
Planned Parenthood Association of Utah
West Valley City, Utah
United Kingdom9 sites
NHS Grampian Sexual and Reproductive Health
Aberdeen
Brook Family Planning Clinic
Belfast
NHS Lothian Family Planning Service
Edinburgh
NHS Greater Glasgow & Clyde Family Planning Service
Glasgow
Liverpool PCT Family Planning Services
Liverpool
London Sexual and Reproductive Health
London
Manchester Primary Care Trust
Manchester
Nottingham Contraception & Sexual Health Service
Nottingham
Oxfordshire PCT Community Health
Oxford
About this study
The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.
- Conditions
- Contraception
- Being tested
- CDB-2914, Levonorgestrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDB-2914Drug
Single dose
LevonorgestrelDrug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| CDB-2914 | Experimental | Not described Receives: Drug: CDB-2914 |
| Levonorgestrel | Active comparator | Not described Receives: Drug: Levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Pregnancy
The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.
Measured: Within 72 hours of unprotected Intercourse
Secondary outcomes (2)
Actual Pregnancy Rate Compared to Expected Pregnancy Rate
Conditional probabilities of pregnancy from the time of unprotected sex intercourse to treatment were estimated for up to 120 hours using Spline Cubic Estimation (Stone \& Koo, 1985) Pregnancy rate expected in the absence of emergency contraception is based on Trussell J, Rodriguez G, Ellertson C. New estimates of the effectiveness of the Yuzpe regimen of emergency contraception. Contraception. 1998;57(6):363-9.
Measured: Within 120 hours of unprotected Intercourse
Menstrual Bleeding Patterns
Onset of next menses after emergency contraception compared to usual date.
Measured: within the menstrual cycle of the unprotected Intercourse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,221 participants (actual)
Sponsor and investigators
- Lead sponsor
- HRA Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna F Glasier, MD, Principal investigator, NHS Lothian Family Planning Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551616
- Sponsor's protocol ID
- 2914-004
- Status last verified
- Apr 2022
- First submitted
- 30 Oct 2007
- Last updated
- 3 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Glasier AF, Cameron ST, Fine PM, Logan SJ, Casale W, Van Horn J, Sogor L, Blithe DL, Scherrer B, Mathe H, Jaspart A, Ulmann A, Gainer E. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet. 2010 Feb 13;375(9714):555-62. doi: 10.1016/S0140-6736(10)60101-8. Epub 2010 Jan 29.
PubMed 20116841
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
- ClinicalTrials.gov ID
- NCT00551616
- Acronym / sponsor ID
- 2914-004
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,221 participants (actual)
- Lead sponsor
- HRA PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 31 Oct 2007 (estimated)
- Results
- Posted 16 Mar 2022
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 study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDB-2914 | Experimental | Drug: CDB-2914 |
| Levonorgestrel | Active comparator | Drug: Levonorgestrel |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US
- present within 120 hours of unprotected intercourse
- regular menstrual cycles
- No current use of hormonal contraception
- Willing to not use hormonal methods of contraception until study completion
Key exclusion criteria (11 listed)
- One or more acts of unprotected intercourse more than 120 hours
- current or recent use of hormonal methods of contraception
- currently pregnant or breastfeeding
- tubal ligation or current use of IUD
- Use of hormonal emergency contraception since last menstrual period
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 |
|---|---|---|
| CDB-2914Single dose | Drug | CDB-2914 |
| LevonorgestrelSingle dose | Drug | Levonorgestrel |
Primary outcome
Number of Participants With Pregnancy
Time frame: Within 72 hours of unprotected Intercourse
The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.
2 secondary outcomes
Actual Pregnancy Rate Compared to Expected Pregnancy Rate
Time frame: Within 120 hours of unprotected Intercourse
Menstrual Bleeding Patterns
Time frame: within the menstrual cycle of the unprotected Intercourse
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20116841Glasier AF, Cameron ST, Fine PM, Logan SJ, Casale W, Van Horn J, Sogor L, Blithe DL, Scherrer B, Mathe H, Jaspart A, Ulmann A, Gainer E. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet. 2010 Feb 13;375(9714):555-62. doi: 10.1016/S0140-6736(10)60101-8. Epub 2010 Jan 29.
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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.
Anna F Glasier, MD principal investigator
NHS Lothian Family Planning Service
33 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CDB-2914 and Levonorgestrel in people with Contraception, run by HRA Pharma at 33 sites in 3 countries.
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 9 inclusion and 11 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, United Kingdom, Ireland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Pregnancy (time frame: Within 72 hours of unprotected Intercourse). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00551616, which also lists 1 linked publication.
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 3 May 2022.