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Trial Outcomes & Findings for Emergency Contraception Actual Use Study (NCT NCT00777556)

NCT ID: NCT00777556

Last Updated: 2012-10-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

343 participants

Primary outcome timeframe

Day 1

Results posted on

2012-10-18

Participant Flow

Three hundred and seventy-nine candidates were screened.

Participant milestones

Participant milestones
Measure
DR-104
One tablet for emergency contraception
Overall Study
STARTED
343
Overall Study
Dispensed Product
307
Overall Study
Safety Population
299
Overall Study
Used Product
297
Overall Study
COMPLETED
277
Overall Study
NOT COMPLETED
66

Reasons for withdrawal

Reasons for withdrawal
Measure
DR-104
One tablet for emergency contraception
Overall Study
Did not complete all 3 follow-up visits
20
Overall Study
Inappropriate self-selection
34
Overall Study
Dispensed but did not use product
12

Baseline Characteristics

Emergency Contraception Actual Use Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
DR-104
n=343 Participants
One tablet for emergency contraception
Age, Categorical
<=18 years
343 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Customized
11-13 years old
3 participants
n=5 Participants
Age, Customized
14 years old
35 participants
n=5 Participants
Age, Customized
15 years old
100 participants
n=5 Participants
Age, Customized
16 years old
140 participants
n=5 Participants
Age, Customized
17 years old
65 participants
n=5 Participants
Sex: Female, Male
Female
343 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Latina
147 participants
n=5 Participants
Race/Ethnicity, Customized
African-American
48 participants
n=5 Participants
Race/Ethnicity, Customized
Multiracial
23 participants
n=5 Participants
Race/Ethnicity, Customized
White
39 participants
n=5 Participants
Race/Ethnicity, Customized
Asian/Pacific Islander
68 participants
n=5 Participants
Race/Ethnicity, Customized
Native American/Alaskan Native
1 participants
n=5 Participants
Race/Ethnicity, Customized
Other
17 participants
n=5 Participants
Ethnic Latina/Hispanic
No answer
17 participants
n=5 Participants
Ethnic Latina/Hispanic
Yes
169 participants
n=5 Participants
Ethnic Latina/Hispanic
No
151 participants
n=5 Participants
Ethnic Latina/Hispanic
Don't know
6 participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Enrolled participants

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.

Outcome measures

Outcome measures
Measure
DR-104
n=343 Participants
One tablet for emergency contraception
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
Interval to 86.4
Not part of analysis plan

PRIMARY outcome

Timeframe: Week 1

Population: Eligible participants who appropriately self-selected and used the product.

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.

Outcome measures

Outcome measures
Measure
DR-104
n=297 Participants
One tablet for emergency contraception
Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions
88.6 percentage of treated participants
Interval to 84.4
not part of analysis plan

SECONDARY outcome

Timeframe: Day 1 to week 8

Population: Safety population of participants who took study drug

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.

Outcome measures

Outcome measures
Measure
DR-104
n=299 Participants
One tablet for emergency contraception
Participants With Treatment-Emergent Adverse Events (TEAE)
At least one TEAE
43 participants
Participants With Treatment-Emergent Adverse Events (TEAE)
Withdrawn from study due to an AE
0 participants
Participants With Treatment-Emergent Adverse Events (TEAE)
At least one SAE
1 participants

SECONDARY outcome

Timeframe: up to week 8

Population: Participants dispensed the product

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.

Outcome measures

Outcome measures
Measure
DR-104
n=307 Participants
One tablet for emergency contraception
Participants Summarized by Repeat Use of Emergency Contraception (EC)
Repeat uses: 0
251 participants
Participants Summarized by Repeat Use of Emergency Contraception (EC)
Repeat uses: 1
38 participants
Participants Summarized by Repeat Use of Emergency Contraception (EC)
Repeat uses: 2
16 participants
Participants Summarized by Repeat Use of Emergency Contraception (EC)
Repeat uses: 3
2 participants

Adverse Events

DR-104

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
DR-104
n=299 participants at risk
One tablet for emergency contraception
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
0.33%
1/299 • Day 1 to week 8. Unresolved AEs and pregnancies were followed until resolved.
Includes participants who took study drug. AE information was solicited during scheduled contacts on weeks 1, 4 and 8.

Other adverse events

Adverse event data not reported

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc.

Phone: 215-591-3000

Results disclosure agreements

  • Principal investigator is a sponsor employee Sponsor has the right before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
  • Publication restrictions are in place

Restriction type: OTHER