Emergency ContraceptionPhase 2/3NCT00271583
Efficacy Trial of CDB 2914 for Emergency Contraception
A Phase 2/3 study testing CDB-2914 and levonorgestrel in people with Emergency Contraception, run by University of Pittsburgh at 6 sites in United States.
Trial summary
Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emergency Contraception
- What is being tested?
- CDB-2914 and levonorgestrel
- How many people
- 1,672 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 1999to Sep 2001
- Phase
- Phase 2/3
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Menstruating women at least 18 years old;
- Give voluntary, written informed consent, and agree to observe all study requirements;
- Request emergency contraception within 72 hours (3 days) after unprotected coitus, as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure;
- Reports that all acts of unprotected coitus during the current cycle are within 72 hours prior to enrollment;
- Willing to abstain from further acts of unprotected intercourse during that cycle;
- History of regular menstrual cycles (mean length of 24-42 days with intra-individual variation of ±5 days);
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- At least one normal menstrual cycle (2 menses) post delivery or abortion;
- If subject recently discontinued hormonal contraception, one normal menstrual cycle (2 menses) must have been completed before entry in the study
- For women with a recent history of Depo Provera use, the most recent injection must be at least 3 months before study entry and the subject must have had at least one normal menstrual cycle (2 menses);
- Available for follow-up for at least the next four weeks.
Who cannot join
- Currently pregnant (positive high-sensitivity urine pregnancy test);
- pregnant or breast-feeding within the past two months;
- use of hormonal methods of contraception during the current or previous two cycles;
- current user of IUD;
- tubal ligation;
- partners with history of vasectomy;
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- unsure about the date of the last menstrual period (+3 days);
- irregular menstrual cycles as defined in the inclusion criteria;
- nausea and vomiting within the previous two weeks;
- impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year.
- Subjects cannot be currently enrolled in any other investigational trial or re-enrolled in this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Cincinnati
Cincinnati, Ohio
University of Colorado
Denver, Colorado
California Family Health Council
Los Angeles, California
New York University
New York, New York
Eastern Virginia Medical School
Norfolk, Virginia
University of Pittsburgh
Pittsburgh, Pennsylvania, 15215
About this study
Official title: A Prospective, Randomized, Double Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerance of CDB-2914 With Levonorgestrel as Emergency Contraception
Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception
Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception
Read more
Subjects are randomized to receive a one-time treatment with either one dose of 50 mg CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)
The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.
Read the detailed description
Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception
Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception
Duration: A one-time treatment with either CDB-2914 or levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)
Treatment: A one-time treatment with one of the following:
- Two doses of 0.75 mg of levonorgestrel to be taken 12 hours apart
- One dose of 50 mg CDB-2914 and a second placebo dose to be taken 12 hours later
Study Sites: Multicenter study in the United States
Subjects: Women of reproductive age (at least 18 years) at risk of pregnancy within 72 hours of unprotected coitus
Sample Size: Approximately 811 women will be enrolled in each treatment group to obtain 1540 evaluable subjects
Outcome Evaluations
Primary: To evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.
Secondary: To compare the tolerability (as measured by vomiting and nausea) of CDB-2914 used by subjects as an emergency postcoital contraceptive with that of a group of subjects receiving levonorgestrel.
Safety/Other: To assess the frequency and intensity of adverse events and the effects on the menstrual cycle of subjects administered CDB-2914 in comparison to subjects given levonorgestrel.
- Conditions
- Emergency Contraception
- Being tested
- CDB-2914, levonorgestrel
- Keywords
- emergency contraception, antiprogestin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDB-2914Drug
levonorgestrelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy (efficacy)
Measured: until follow-up about one week after next menses
Secondary outcomes (2)
Tolerability (side effects)
Measured: until follow-up about one week after next menses
Menstrual cycle effects
Measured: until follow-up about one week after next menses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2006 (estimated)
- Study startSep 1999
- Study completionSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency ContraceptionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 1,672 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Diana Blithe, PhD, Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271583
- Sponsor's protocol ID
- CCN002
- Other IDs
- N01-HD-9-3298
- Status last verified
- Dec 2007
- First submitted
- 29 Dec 2005
- Last updated
- 17 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Creinin MD, Schlaff W, Archer DF, Wan L, Frezieres R, Thomas M, Rosenberg M, Higgins J. Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Obstet Gynecol. 2006 Nov;108(5):1089-97. doi: 10.1097/01.AOG.0000239440.02284.45.
PubMed 17077229
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerance of CDB-2914 With Levonorgestrel as Emergency Contraception
- ClinicalTrials.gov ID
- NCT00271583
- Acronym / sponsor ID
- CCN002
- Conditions
- Emergency Contraception
- Keywords
- emergency contraception, antiprogestin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,672 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 1999
- Study completion
- Sep 2001 (actual)
- First posted
- 2 Jan 2006 (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.
Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception
Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception
Subjects are randomized to receive a one-time treatment with either one dose of 50 mg CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)
The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.
Detailed description
Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception
Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception
Duration: A one-time treatment with either CDB-2914 or levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)
Treatment: A one-time treatment with one of the following:
- Two doses of 0.75 mg of levonorgestrel to be taken 12 hours apart
- One dose of 50 mg CDB-2914 and a second placebo dose to be taken 12 hours later
Study Sites: Multicenter study in the United States
Subjects: Women of reproductive age (at least 18 years) at risk of pregnancy within 72 hours of unprotected coitus
Sample Size: Approximately 811 women will be enrolled in each treatment group to obtain 1540 evaluable subjects
Outcome Evaluations
Primary: To evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.
Secondary: To compare the tolerability (as measured by vomiting and nausea) of CDB-2914 used by subjects as an emergency postcoital contraceptive with that of a group of subjects receiving levonorgestrel.
Safety/Other: To assess the frequency and intensity of adverse events and the effects on the menstrual cycle of subjects administered CDB-2914 in comparison to subjects given levonorgestrel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Menstruating women at least 18 years old;
- Give voluntary, written informed consent, and agree to observe all study requirements;
- Request emergency contraception within 72 hours (3 days) after unprotected coitus, as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure;
- Reports that all acts of unprotected coitus during the current cycle are within 72 hours prior to enrollment;
- Willing to abstain from further acts of unprotected intercourse during that cycle;
Key exclusion criteria (11 listed)
- Currently pregnant (positive high-sensitivity urine pregnancy test);
- pregnant or breast-feeding within the past two months;
- use of hormonal methods of contraception during the current or previous two cycles;
- current user of IUD;
- tubal ligation;
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 | – |
| levonorgestrel | Drug | – |
Primary outcome
Pregnancy (efficacy)
Time frame: until follow-up about one week after next menses
2 secondary outcomes
Tolerability (side effects)
Time frame: until follow-up about one week after next menses
Menstrual cycle effects
Time frame: until follow-up about one week after next menses
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 17 Dec 2007.
- Results publication: PubMed 17077229Creinin MD, Schlaff W, Archer DF, Wan L, Frezieres R, Thomas M, Rosenberg M, Higgins J. Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Obstet Gynecol. 2006 Nov;108(5):1089-97. doi: 10.1097/01.AOG.0000239440.02284.45.
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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.
Diana Blithe, PhD principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CDB-2914 and levonorgestrel in people with Emergency Contraception, run by University of Pittsburgh at 6 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 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 17 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 (efficacy) (time frame: until follow-up about one week after next menses). 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 NCT00271583, 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 17 Dec 2007.