Contraception
Conditions
Brief summary
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.
Interventions
DRUGCDB-2914
Single dose
DRUGLevonorgestrel
Single dose
Sponsors
HRA Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US * present within 120 hours of unprotected intercourse * regular menstrual cycles * No current use of hormonal contraception * Willing to not use hormonal methods of contraception until study completion * At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion * For women who present more than 72 hours after intercourse, decline the insertion of an Intra Uterine Device for emergency contraception * Able to provide informed consent * Willing to abstain from further acts of unprotected intercourse until study completion
Exclusion criteria
* One or more acts of unprotected intercourse more than 120 hours * current or recent use of hormonal methods of contraception * currently pregnant or breastfeeding * tubal ligation or current use of IUD * Use of hormonal emergency contraception since last menstrual period * 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 * Hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Menstrual Bleeding Patterns | within the menstrual cycle of the unprotected Intercourse | Onset of next menses after emergency contraception compared to usual date. |
| 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. |
Countries
Ireland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CDB-2914 CDB-2914: Single dose (30 mg) | 1,104 |
| Levonorgestrel Levonorgestrel: Single dose (1.5 mg) | 1,117 |
| Total | 2,221 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 48 | 40 |
Baseline characteristics
| Characteristic | Total | CDB-2914 | Levonorgestrel |
|---|---|---|---|
| Age, Categorical <=18 years | 93 Participants | 44 Participants | 49 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2128 Participants | 1060 Participants | 1068 Participants |
| Age, Continuous | 24.7 years STANDARD_DEVIATION 6.3 | 24.5 years STANDARD_DEVIATION 6.1 | 24.9 years STANDARD_DEVIATION 6.5 |
| Race/Ethnicity, Customized Asian | 34 Participants | 13 Participants | 21 Participants |
| Race/Ethnicity, Customized Black | 417 Participants | 210 Participants | 207 Participants |
| Race/Ethnicity, Customized Other | 157 Participants | 77 Participants | 80 Participants |
| Race/Ethnicity, Customized White | 1613 Participants | 804 Participants | 809 Participants |
| Sex: Female, Male Female | 2221 Participants | 1104 Participants | 1117 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Time from unprotected sexual intercourse to emergency contraception (hours) 0-24h | 762 Participants | 367 Participants | 395 Participants |
| Time from unprotected sexual intercourse to emergency contraception (hours) >120h | 4 Participants | 1 Participants | 3 Participants |
| Time from unprotected sexual intercourse to emergency contraception (hours) 25-48h | 766 Participants | 388 Participants | 378 Participants |
| Time from unprotected sexual intercourse to emergency contraception (hours) 49-72h | 457 Participants | 238 Participants | 219 Participants |
| Time from unprotected sexual intercourse to emergency contraception (hours) 73-96h | 158 Participants | 72 Participants | 86 Participants |
| Time from unprotected sexual intercourse to emergency contraception (hours) 97-120h | 74 Participants | 38 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,104 | 0 / 1,117 |
| other Total, other adverse events | 596 / 1,104 | 572 / 1,117 |
| serious Total, serious adverse events | 3 / 1,104 | 4 / 1,117 |
Outcome results
Primary
Number of Participants With Pregnancy
The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.
Time frame: Within 72 hours of unprotected Intercourse
Population: Intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CDB-2914 | Number of Participants With Pregnancy | 20 Participants |
| Levonorgestrel | Number of Participants With Pregnancy | 30 Participants |
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.
Time frame: Within 120 hours of unprotected Intercourse
Population: 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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDB-2914 | Actual Pregnancy Rate Compared to Expected Pregnancy Rate | Number of pregnancies observed | 15 Participants |
| CDB-2914 | Actual Pregnancy Rate Compared to Expected Pregnancy Rate | Number of expected pregnancies | 47 Participants |
| Levonorgestrel | Actual Pregnancy Rate Compared to Expected Pregnancy Rate | Number of pregnancies observed | 22 Participants |
| Levonorgestrel | Actual Pregnancy Rate Compared to Expected Pregnancy Rate | Number of expected pregnancies | 46 Participants |
Comparison: Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998p-value: <0.00195% CI: [1.04, 2.98]Chi-squared
Comparison: Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998p-value: <0.00195% CI: [1.68, 3.94]Chi-squared
Secondary
Menstrual Bleeding Patterns
Onset of next menses after emergency contraception compared to usual date.
Time frame: within the menstrual cycle of the unprotected Intercourse
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDB-2914 | Menstrual Bleeding Patterns | 2.1 DAYS | Standard Deviation 8.2 |
| Levonorgestrel | Menstrual Bleeding Patterns | -1.2 DAYS | Standard Deviation 7.9 |