Emergency Contraception
Conditions
Brief summary
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.
Interventions
DRUGCDB-2914
Sponsors
HRA Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or more * Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days * Request emergency contraception between 48 hours and 120 hours after unprotected intercourse as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure * No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since having stopped hormonal contraception * For women with a recent history of Depo Provera use, the most recent injection must have been at least 9 months before study entry and followed by at least one complete menstrual cycle (2 menses) * Willing to not use hormonal methods of contraception until study completion * At least one complete menstrual cycle (2 menses) post delivery, miscarriage or abortion * Able to provide informed consent in English * Give voluntary, written informed consent, and agree to observe all study requirements (the subject needs to be available for follow-up over the next 6 weeks) * Willing to abstain from further acts of unprotected intercourse during participation in the study and until pregnancy status has been ascertained
Exclusion criteria
* One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle * All acts of unprotected intercourse (in the current cycle) within 48 hours of presentation * Currently pregnant as confirmed by positive HSUP test performed at screening * Currently breast-feeding * Current use of hormonal contraception * 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 * Currently enrolled in any other trial of an investigational medicine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate | Up to 60 days after enrollment | 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: * 5-7 days after expected date of menses * 1 week later * every two week after |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies) | within the menstrual cycle of the unprotected Intercourse | Number of prevented pregnancies divided by the number of expected pregnancies |
| Impact on Menstrual Bleeding Patterns | within the menstrual cycle of the unprotected Intercourse | Menstrual cycle length post treatment |
| Frequencies of Subjects With Treatment Emergent Adverse Events | 12-14 days after expected menses | Most common related adverse events in ITT population. |
Countries
United States
Participant flow
Pre-assignment details
Screening 1623 Screening failures 90 Enrolled 1533
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1,533 |
| Total | 1,533 |
Baseline characteristics
| Characteristic | Exp Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1533 Participants |
| Age, Continuous | 24.4 years STANDARD_DEVIATION 6.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 338 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1182 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 21 Participants |
| Race (NIH/OMB) Asian | 35 Participants |
| Race (NIH/OMB) Black or African American | 328 Participants |
| Race (NIH/OMB) More than one race | 212 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 11 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 921 Participants |
| Region of Enrollment United States | 1533 participants |
| Sex: Female, Male Female | 1533 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 557 / 1,533 |
| serious Total, serious adverse events | 1 / 1,533 |
Outcome results
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: * 5-7 days after expected date of menses * 1 week later * every two week after
Time frame: Up to 60 days after enrollment
Population: Primary efficacy population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDB-2914 | Pregnancy Rate | 2.1 percentage of participants |
Secondary
Frequencies of Subjects With Treatment Emergent Adverse Events
Most common related adverse events in ITT population.
Time frame: 12-14 days after expected menses
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CDB-2914 | Frequencies of Subjects With Treatment Emergent Adverse Events | Headache | 9.3 percentage of participants |
| CDB-2914 | Frequencies of Subjects With Treatment Emergent Adverse Events | Nausea | 9.2 percentage of participants |
| CDB-2914 | Frequencies of Subjects With Treatment Emergent Adverse Events | Abdominal pain | 6.8 percentage of participants |
| CDB-2914 | Frequencies of Subjects With Treatment Emergent Adverse Events | Dysmenorrhea | 4.1 percentage of participants |
| CDB-2914 | Frequencies of Subjects With Treatment Emergent Adverse Events | Dizziness | 3.5 percentage of participants |
| CDB-2914 | Frequencies of Subjects With Treatment Emergent Adverse Events | Fatigue | 3.4 percentage of participants |
Secondary
Impact on Menstrual Bleeding Patterns
Menstrual cycle length post treatment
Time frame: within the menstrual cycle of the unprotected Intercourse
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDB-2914 | Impact on Menstrual Bleeding Patterns | 31.8 Days | Standard Deviation 10.2 |
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
Time frame: within the menstrual cycle of the unprotected Intercourse
Population: Primary efficacy population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDB-2914 | Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies) | 62.3 percentage of participants |