Trial · NCT00551616
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
NCT00551616, Phase 3, Completed, HRA Pharma; results first posted 2022-03-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception. Trials, record NCT00551616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00551616
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
- NCT number
- NCT00551616
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,221 participants, actual
- Lead sponsor
- HRA Pharma
- Conditions
- Contraception
- Interventions
- CDB-2914, Levonorgestrel
- First posted
- 2007-10-31
- Last updated
- 2022-05-03
- Results first posted
- 2022-03-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Pregnancy | Within 72 hours of unprotected Intercourse | The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse. |
| Secondary | Actual Pregnancy Rate Compared to Expected Pregnancy Rate | Within 120 hours of unprotected Intercourse | 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. |
| Secondary | Menstrual Bleeding Patterns | within the menstrual cycle of the unprotected Intercourse | Onset of next menses after emergency contraception compared to usual date. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Pregnancy | Within 72 hours of unprotected Intercourse | Intention to treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Actual Pregnancy Rate Compared to Expected Pregnancy Rate | Within 120 hours of unprotected Intercourse | 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) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Menstrual Bleeding Patterns | within the menstrual cycle of the unprotected Intercourse | Intent to Treat | DAYS | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Pregnancy | CDB-2914 | 20 | Participants | ||
| Number of Participants With Pregnancy | Levonorgestrel | 30 | Participants | ||
| Actual Pregnancy Rate Compared to Expected Pregnancy Rate | CDB-2914 | Number of pregnancies observed | 15 | Participants | |
| Actual Pregnancy Rate Compared to Expected Pregnancy Rate | Levonorgestrel | Number of pregnancies observed | 22 | Participants | |
| Actual Pregnancy Rate Compared to Expected Pregnancy Rate | CDB-2914 | Number of expected pregnancies | 47 | Participants | |
| Actual Pregnancy Rate Compared to Expected Pregnancy Rate | Levonorgestrel | Number of expected pregnancies | 46 | Participants | |
| Menstrual Bleeding Patterns | CDB-2914 | 2.1 | Standard Deviation 8.2 | DAYS | |
| Menstrual Bleeding Patterns | Levonorgestrel | -1.2 | Standard Deviation 7.9 | DAYS |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CDB-2914 | 1,104 | |
| Overall Study | STARTED | Levonorgestrel | 1,117 | |
| Overall Study | COMPLETED | CDB-2914 | 1,056 | |
| Overall Study | COMPLETED | Levonorgestrel | 1,077 | |
| Overall Study | NOT COMPLETED | CDB-2914 | 48 | |
| Overall Study | NOT COMPLETED | Levonorgestrel | 40 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | CDB-2914 | 213 | 1,104 | 213 |
| other | Headache | Nervous system disorders | Levonorgestrel | 211 | 1,117 | 211 |
| other | Dysmenorrhoea | Reproductive system and breast disorders | CDB-2914 | 142 | 1,104 | 142 |
| other | Dysmenorrhoea | Reproductive system and breast disorders | Levonorgestrel | 160 | 1,117 | 160 |
| other | Nausea | Gastrointestinal disorders | CDB-2914 | 141 | 1,104 | 141 |
| other | Nausea | Gastrointestinal disorders | Levonorgestrel | 126 | 1,117 | 126 |
| other | Abdominal pain | Gastrointestinal disorders | CDB-2914 | 56 | 1,104 | 56 |
| other | Abdominal pain | Gastrointestinal disorders | Levonorgestrel | 75 | 1,117 | 75 |
| other | Dizziness | Nervous system disorders | CDB-2914 | 56 | 1,104 | 56 |
| other | Dizziness | Nervous system disorders | Levonorgestrel | 55 | 1,117 | 55 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CDB-2914 | 0 | 1,104 |
| Total, all-cause mortality | Levonorgestrel | 0 | 1,117 |
| Total, other adverse events | CDB-2914 | 596 | 1,104 |
| Total, other adverse events | Levonorgestrel | 572 | 1,117 |
| Total, serious adverse events | CDB-2914 | 3 | 1,104 |
| Total, serious adverse events | Levonorgestrel | 4 | 1,117 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20116841 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CDB-2914 vs Levonorgestrel: Number of Participants With Pregnancy | Trial comparisons |
| CDB-2914 vs Levonorgestrel: deaths from any cause | Trial comparisons |
| CDB-2914 vs Levonorgestrel: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00551616
GET https://conductscience.org/api/trials/v1/NCT00551616/events?page=2