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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDB-2914 | Experimental |
| |
| Levonorgestrel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDB-2914 | Drug | Single dose |
| |
| Levonorgestrel |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pregnancy | The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse. | Within 72 hours of unprotected Intercourse |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna F Glasier, MD | NHS Lothian Family Planning Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Hollywood | Los Angeles | California | United States | |||
| Planned Parenthood Santa Monica |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20116841 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CDB-2914 | CDB-2914: Single dose (30 mg) |
| FG001 | Levonorgestrel | Levonorgestrel: Single dose (1.5 mg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Single dose |
|
| Within 120 hours of unprotected Intercourse |
| Menstrual Bleeding Patterns | Onset of next menses after emergency contraception compared to usual date. | within the menstrual cycle of the unprotected Intercourse |
| Santa Monica |
| California |
| United States |
| Planned Parenthood of the Rocky Mountains | Boulder | Colorado | United States |
| Planned Parenthood of the Rocky Mountains | Denver | Colorado | United States |
| Planned Parenthood of the Rocky Mountains | Littleton | Colorado | United States |
| Planned Parenthood of Greater Miami | Lake Worth | Florida | United States |
| Planned Parenthood of Greater Miami | Miami | Florida | United States |
| Planned Parenthood of Greater Miami | North Miami | Florida | United States |
| Planned Parenthood of Greater Miami | Stuart | Florida | United States |
| Planned Parenthood of Greater Miami | West Palm Beach | Florida | United States |
| Planned Parenthood of Northeast Ohio Akron Health Center | Akron | Ohio | United States |
| Planned Parenthood of Northeast Ohio Bedford Health Center | Bedford | Ohio | United States |
| Planned Parenthood of Northeast Ohio East Cleveland Health Center | Cleveland | Ohio | United States |
| Planned Parenthood of Northeast Ohio Old Brooklyn Health Center | Cleveland | Ohio | United States |
| Planned Parenthood of Northeast Ohio Kent Health Center | Kent | Ohio | United States |
| Planned Parenthood of Northeast Ohio Rocky River Health Center | Rocky River | Ohio | United States |
| Planned Parenthood of Texas Capitol Region | Austin | Texas | United States |
| Fannin Health Center | Houston | Texas | United States |
| Planned Parenthood of Houston and Southeast Texas Research Department | Houston | Texas | United States |
| Planned Parenthood Association of Utah | Ogden | Utah | United States |
| Planned Parenthood Association of Utah | Orem | Utah | United States |
| Planned Parenthood Association of Utah | Salt Lake City | Utah | United States |
| Planned Parenthood Association of Utah | West Valley City | Utah | United States |
| Well Woman Centre | Dublin | Ireland |
| NHS Grampian Sexual and Reproductive Health | Aberdeen | United Kingdom |
| Brook Family Planning Clinic | Belfast | United Kingdom |
| NHS Lothian Family Planning Service | Edinburgh | United Kingdom |
| NHS Greater Glasgow & Clyde Family Planning Service | Glasgow | United Kingdom |
| Liverpool PCT Family Planning Services | Liverpool | United Kingdom |
| London Sexual and Reproductive Health | London | United Kingdom |
| Manchester Primary Care Trust | Manchester | United Kingdom |
| Nottingham Contraception & Sexual Health Service | Nottingham | United Kingdom |
| Oxfordshire PCT Community Health | Oxford | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CDB-2914 | CDB-2914: Single dose (30 mg) |
| BG001 | Levonorgestrel | Levonorgestrel: Single dose (1.5 mg) |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Time from unprotected sexual intercourse to emergency contraception (hours) | Count of Participants | 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 | Number of Participants With Pregnancy | The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse. | Intention to treat | Posted | Count of Participants | Participants | Within 72 hours of unprotected Intercourse |
|
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| |||||||||||||||||||||||||||||
| Secondary | 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. | Efficacy evaluable population (women aged 35 years or younger who were enrolled for the first time in the study and whose pregnancy status after treatment was known) | Posted | Count of Participants | Participants | Within 120 hours of unprotected Intercourse |
|
| ||||||||||||||||||||||||||||||
| Secondary | Menstrual Bleeding Patterns | Onset of next menses after emergency contraception compared to usual date. | Intent to Treat | Posted | Mean | Standard Deviation | DAYS | within the menstrual cycle of the unprotected Intercourse |
|
|
At the most 60 days after treatment.
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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 | CDB-2914: Single dose (30 mg) | 0 | 1,104 | 3 | 1,104 | 596 | 1,104 |
| EG001 | Levonorgestrel | Levonorgestrel: Single dose (1.5 mg) | 0 | 1,117 | 4 | 1,117 | 572 | 1,117 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Right contact lense related corneal ulcer | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Dizziness | General disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Vomiting blood stained fluid | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Molar pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 9.0 | Non-systematic Assessment |
| |
| ruptured ovarian cyst | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Kidney stones | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Henri Mathé | HRA Pharma | +33140331130 | medical2914@hra-pharma.com |
| ID | Term |
|---|---|
| C094854 | ulipristal |
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| >=65 years |
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| Male |
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| Black |
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| Asian |
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| Other |
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| 25-48h |
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| 49-72h |
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| 73-96h |
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| 97-120h |
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| >120h |
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