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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDB-2914 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Up to 60 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies) | Number of prevented pregnancies divided by the number of expected pregnancies | within the menstrual cycle of the unprotected Intercourse |
| Impact on Menstrual Bleeding Patterns |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Fine, MD | Planned Parenthood of Houston and Southeast Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of Mar Monte | San Jose | California | 95126 | United States | ||
| Planned Parenthood of the Rocky Mountains |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20093897 | Result | 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. |
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Screening 1623 Screening failures 90 Enrolled 1533
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| ID | Title | Description |
|---|---|---|
| FG000 | CDB-2914 | 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 CDB-2914 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Menstrual cycle length post treatment |
| within the menstrual cycle of the unprotected Intercourse |
| Frequencies of Subjects With Treatment Emergent Adverse Events | Most common related adverse events in ITT population. | 12-14 days after expected menses |
| Denver |
| Colorado |
| 80203 |
| United States |
| Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost | Miami | Florida | United States |
| Planned Parenthood of South Palm Beach, Pembroke Pines | Pembroke Pines | Florida | United States |
| Planned Parenthood of Indiana | Bloomington | Indiana | United States |
| Planned Parenthood of Greater Iowa | Ames | Iowa | United States |
| Planned Parenthood of Maryland | Baltimore | Maryland | 21201 | United States |
| Planned Parenthood League of Massachusetts | Boston | Massachusetts | 02215 | United States |
| Planned Parenthood of Mid-Michigan Alliance | Ann Arbor | Michigan | United States |
| Planned Parenthood of Minnesota | Minneapolis | Minnesota | United States |
| Planned Parenthood of Greater Cleveland | Cleveland | Ohio | United States |
| Planned Parenthood of Columbia-Willamette | Portland | Oregon | 97206 | United States |
| Planned Parenthood of SE Philadelphia | Philadelphia | Pennsylvania | United States |
| Planned Parenthood of the Texas Capital Region | Austin | Texas | United States |
| Planned Parenthood of Houston and Southeast Texas | Houston | Texas | 77004 | United States |
| Planned Parenthood Association of Utah | Salt Lake City | Utah | United States |
| Planned Parenthood of Western Washington | Seattle | Washington | 98122 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | Exp Arm | 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 CDB-2914 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Primary efficacy population | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 60 days after enrollment |
|
|
| |||||||||||||||||||||||||
| Secondary | Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies) | Number of prevented pregnancies divided by the number of expected pregnancies | Primary efficacy population | Posted | Number | 95% Confidence Interval | percentage of participants | within the menstrual cycle of the unprotected Intercourse |
|
| ||||||||||||||||||||||||||
| Secondary | Impact on Menstrual Bleeding Patterns | Menstrual cycle length post treatment | ITT Population | Posted | Mean | Standard Deviation | Days | within the menstrual cycle of the unprotected Intercourse |
|
| ||||||||||||||||||||||||||
| Secondary | Frequencies of Subjects With Treatment Emergent Adverse Events | Most common related adverse events in ITT population. | ITT Population | Posted | Number | percentage of participants | 12-14 days after expected menses |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CDB-2914 | 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 CDB-2914 | 1 | 1,533 | 557 | 1,533 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysmenorrhea | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Carter - Chief Scientific Officer | HRA Pharma | +33 1 40 33 11 30 | p.carter@hra-pharma.com |
| ID | Term |
|---|---|
| C094854 | ulipristal |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Headache |
| |||||
| Nausea |
| |||||
| Abdominal pain |
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| Dysmenorrhea |
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| Dizziness |
| |||||
| Fatigue |
|