Emergency Contraception
Conditions
Brief summary
This is a non-comparative case series study to assess the ability of females 11-16 years of age, inclusive, who are requesting emergency contraception (EC) to use the study product, DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.
Detailed description
To simulate an over-the-counter (OTC) setting, each potential subject was expected to read the label text on the outside of the study package and determine whether and how to use the study product without provider direction or assistance. The study product, Plan B® 1.5, was to be dispensed only to those subjects who appropriately self-selected and indicated that they wanted to participate in the study and receive study product. Subjects could also appropriately self-select not to use the study product. Follow-up contact was to be conducted at approximately one, four, and eight weeks following the date the subject was dispensed study product. At these contacts, subjects answered questions regarding product use, health problems since last contact, and pregnancy status. Subjects were not to be permitted to enroll more than once in this Actual Use Study, however to assess repeat use of emergency contraceptives (EC) (use in addition to the study product) subjects were also queried at the one-, four-, and eight-week follow-up contacts regarding use of additional EC.
Interventions
DRUGDR-104
One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.
Sponsors
Duramed Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Female and 11-16 years of age, inclusive * Subject must be requesting emergency contraception for her own use (not for use by another person) and for current (not future) use * Subject can read and understand English, according to her own judgment * Others as dictated by FDA-approved protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions | Day 1 | The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them. |
| Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions | Week 1 | The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Treatment-Emergent Adverse Events (TEAE) | Day 1 to week 8 | Treatment-emergent adverse events included adverse events reported during the protocol-specified following up contacts at weeks 1, 4 and 8 or at any other participant contact for participants who took study drug. |
| Participants Summarized by Repeat Use of Emergency Contraception (EC) | up to week 8 | As each participant dispensed Plan B® 1.5 was only given one tablet, repeat use of emergency contraception (EC) indicates use of an EC product other than the study product. Categories reflect the number of repeat uses. |
Countries
United States
Participant flow
Pre-assignment details
Three hundred and seventy-nine candidates were screened.
Participants by arm
| Arm | Count |
|---|---|
| DR-104 One tablet for emergency contraception | 343 |
| Total | 343 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not complete all 3 follow-up visits | 20 |
| Overall Study | Dispensed but did not use product | 12 |
| Overall Study | Inappropriate self-selection | 34 |
Baseline characteristics
| Characteristic | DR-104 |
|---|---|
| Age, Categorical <=18 years | 343 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Customized 11-13 years old | 3 participants |
| Age, Customized 14 years old | 35 participants |
| Age, Customized 15 years old | 100 participants |
| Age, Customized 16 years old | 140 participants |
| Age, Customized 17 years old | 65 participants |
| Ethnic Latina/Hispanic Don't know | 6 participants |
| Ethnic Latina/Hispanic No | 151 participants |
| Ethnic Latina/Hispanic No answer | 17 participants |
| Ethnic Latina/Hispanic Yes | 169 participants |
| Race/Ethnicity, Customized African-American | 48 participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 68 participants |
| Race/Ethnicity, Customized Latina | 147 participants |
| Race/Ethnicity, Customized Multiracial | 23 participants |
| Race/Ethnicity, Customized Native American/Alaskan Native | 1 participants |
| Race/Ethnicity, Customized Other | 17 participants |
| Race/Ethnicity, Customized White | 39 participants |
| Sex: Female, Male Female | 343 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 | 0 / 299 |
| serious Total, serious adverse events | 1 / 299 |
Outcome results
Primary
Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions
The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them.
Time frame: Day 1
Population: Enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-104 | Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions | 90.1 percentage of participants |
Primary
Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions
The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions.
Time frame: Week 1
Population: Eligible participants who appropriately self-selected and used the product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-104 | Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions | 88.6 percentage of treated participants |
Secondary
Participants Summarized by Repeat Use of Emergency Contraception (EC)
As each participant dispensed Plan B® 1.5 was only given one tablet, repeat use of emergency contraception (EC) indicates use of an EC product other than the study product. Categories reflect the number of repeat uses.
Time frame: up to week 8
Population: Participants dispensed the product
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-104 | Participants Summarized by Repeat Use of Emergency Contraception (EC) | Repeat uses: 0 | 251 participants |
| DR-104 | Participants Summarized by Repeat Use of Emergency Contraception (EC) | Repeat uses: 1 | 38 participants |
| DR-104 | Participants Summarized by Repeat Use of Emergency Contraception (EC) | Repeat uses: 2 | 16 participants |
| DR-104 | Participants Summarized by Repeat Use of Emergency Contraception (EC) | Repeat uses: 3 | 2 participants |
Secondary
Participants With Treatment-Emergent Adverse Events (TEAE)
Treatment-emergent adverse events included adverse events reported during the protocol-specified following up contacts at weeks 1, 4 and 8 or at any other participant contact for participants who took study drug.
Time frame: Day 1 to week 8
Population: Safety population of participants who took study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-104 | Participants With Treatment-Emergent Adverse Events (TEAE) | At least one TEAE | 43 participants |
| DR-104 | Participants With Treatment-Emergent Adverse Events (TEAE) | Withdrawn from study due to an AE | 0 participants |
| DR-104 | Participants With Treatment-Emergent Adverse Events (TEAE) | At least one SAE | 1 participants |