Emergency ContraceptionPhase 3NCT00411684
Safety and Efficacy of CDB-2914 for Emergency Contraception
A Phase 3 study testing CDB-2914 in people with Emergency Contraception, run by HRA Pharma at 17 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Emergency Contraception
- What is being tested?
- CDB-2914
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,623 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2006to 5 Jun 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or more
- Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days
- Request emergency contraception between 48 hours and 120 hours after unprotected intercourse as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure
- No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since having stopped hormonal contraception
- For women with a recent history of Depo Provera use, the most recent injection must have been at least 9 months before study entry and followed by at least one complete menstrual cycle (2 menses)
- Willing to not use hormonal methods of contraception until study completion
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- At least one complete menstrual cycle (2 menses) post delivery, miscarriage or abortion
- Able to provide informed consent in English
- Give voluntary, written informed consent, and agree to observe all study requirements (the subject needs to be available for follow-up over the next 6 weeks)
- Willing to abstain from further acts of unprotected intercourse during participation in the study and until pregnancy status has been ascertained
Who cannot join
- One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle
- All acts of unprotected intercourse (in the current cycle) within 48 hours of presentation
- Currently pregnant as confirmed by positive HSUP test performed at screening
- Currently breast-feeding
- Current use of hormonal contraception
- Use of hormonal emergency contraception since last menstrual period
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- Current use of IUD
- Tubal ligation
- Partner with a vasectomy
- Unsure about the date of the last menstrual period
- Severe asthma insufficiently controlled by oral glucocorticoid
- Currently enrolled in any other trial of an investigational medicine
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Planned Parenthood of Greater Iowa
Ames, Iowa
Planned Parenthood of Mid-Michigan Alliance
Ann Arbor, Michigan
Planned Parenthood of the Texas Capital Region
Austin, Texas
Planned Parenthood of Maryland
Baltimore, Maryland, 21201
Planned Parenthood of Indiana
Bloomington, Indiana
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
Planned Parenthood of Greater Cleveland
Cleveland, Ohio
Planned Parenthood of the Rocky Mountains
Denver, Colorado, 80203
Planned Parenthood of Houston and Southeast Texas
Houston, Texas, 77004
Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost
Miami, Florida
Planned Parenthood of Minnesota
Minneapolis, Minnesota
Planned Parenthood of South Palm Beach, Pembroke Pines
Pembroke Pines, Florida
Planned Parenthood of SE Philadelphia
Philadelphia, Pennsylvania
Planned Parenthood of Columbia-Willamette
Portland, Oregon, 97206
Planned Parenthood Association of Utah
Salt Lake City, Utah
Planned Parenthood of Mar Monte
San Jose, California, 95126
Planned Parenthood of Western Washington
Seattle, Washington, 98122
About this study
Official title: A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CDB-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Sex
The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.
- Conditions
- Emergency Contraception
- Being tested
- CDB-2914
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDB-2914Drug
| Study group | Role | What they receive |
|---|---|---|
| CDB-2914 | Experimental | A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse Receives: Drug: CDB-2914 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points:
- 5-7 days after expected date of menses
- 1 week later
- every two week after
Measured: Up to 60 days after enrollment
Secondary outcomes (3)
Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)
Number of prevented pregnancies divided by the number of expected pregnancies
Measured: within the menstrual cycle of the unprotected Intercourse
Impact on Menstrual Bleeding Patterns
Menstrual cycle length post treatment
Measured: within the menstrual cycle of the unprotected Intercourse
Frequencies of Subjects With Treatment Emergent Adverse Events
Most common related adverse events in ITT population.
Measured: 12-14 days after expected menses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study startNov 2006
- Primary completion8 Apr 2008
- Study completion5 Jun 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 Emergency 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,623 participants (actual)
Sponsor and investigators
- Lead sponsor
- HRA Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Fine, MD, Principal investigator, Planned Parenthood of Houston and Southeast Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411684
- Sponsor's protocol ID
- 2914-005
- Status last verified
- Apr 2021
- First submitted
- 13 Dec 2006
- Last updated
- 21 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Fine P, Mathe H, Ginde S, Cullins V, Morfesis J, Gainer E. Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception. Obstet Gynecol. 2010 Feb;115(2 Pt 1):257-263. doi: 10.1097/AOG.0b013e3181c8e2aa.
PubMed 20093897
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CDB-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Sex
- ClinicalTrials.gov ID
- NCT00411684
- Acronym / sponsor ID
- 2914-005
- Conditions
- Emergency Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,623 participants (actual)
- Lead sponsor
- HRA PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- 8 Apr 2008 (actual)
- Study completion
- 5 Jun 2009 (actual)
- First posted
- 14 Dec 2006 (estimated)
- Results
- Posted 3 May 2021
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 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDB-2914 | Experimental | Drug: CDB-2914A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 years or more
- Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days
- Request emergency contraception between 48 hours and 120 hours after unprotected intercourse as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure
- No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since having stopped hormonal contraception
- For women with a recent history of Depo Provera use, the most recent injection must have been at least 9 months before study entry and followed by at least one complete menstrual cycle (2 menses)
Key exclusion criteria (12 listed)
- One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle
- All acts of unprotected intercourse (in the current cycle) within 48 hours of presentation
- Currently pregnant as confirmed by positive HSUP test performed at screening
- Currently breast-feeding
- Current use of hormonal contraception
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-2914 | Drug | CDB-2914 |
Primary outcome
Pregnancy Rate
Time frame: Up to 60 days after enrollment
A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points: * 5-7 days after expected date of menses * 1 week later * every two week after
3 secondary outcomes
Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)
Time frame: within the menstrual cycle of the unprotected Intercourse
Impact on Menstrual Bleeding Patterns
Time frame: within the menstrual cycle of the unprotected Intercourse
Frequencies of Subjects With Treatment Emergent Adverse Events
Time frame: 12-14 days after expected menses
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20093897Fine P, Mathe H, Ginde S, Cullins V, Morfesis J, Gainer E. Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception. Obstet Gynecol. 2010 Feb;115(2 Pt 1):257-263. doi: 10.1097/AOG.0b013e3181c8e2aa.
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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 Fine, MD principal investigator
Planned Parenthood of Houston and Southeast Texas
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CDB-2914 in people with Emergency Contraception, run by HRA Pharma at 17 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 10 inclusion and 12 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 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 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 3 May 2021). 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?
Pregnancy Rate (time frame: Up to 60 days after enrollment). 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 NCT00411684, 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 21 Sep 2021.