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Emergency Contraception Actual Use Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00777556
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : October 18, 2012
Last Update Posted : October 18, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Emergency Contraception
Intervention Drug: DR-104
Enrollment 343
Recruitment Details  
Pre-assignment Details Three hundred and seventy-nine candidates were screened.
Arm/Group Title DR-104
Hide Arm/Group Description One tablet for emergency contraception
Period Title: Overall Study
Started 343 [1]
Dispensed Product 307
Safety Population 299 [2]
Used Product 297
Completed 277 [3]
Not Completed 66
Reason Not Completed
Inappropriate self-selection             34
Dispensed but did not use product             12
Did not complete all 3 follow-up visits             20
[1]
Enrolled; signed informed consent
[2]
Participants who used the product; two were given product in error (inappropriately self-selected)
[3]
Completed all 3 follow-up visits
Arm/Group Title DR-104
Hide Arm/Group Description One tablet for emergency contraception
Overall Number of Baseline Participants 343
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants
<=18 years
343
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants
11-13 years old 3
14 years old 35
15 years old 100
16 years old 140
17 years old 65
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants
Female
343
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants
Latina 147
African-American 48
Multiracial 23
White 39
Asian/Pacific Islander 68
Native American/Alaskan Native 1
Other 17
Ethnic Latina/Hispanic   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants
No answer 17
Yes 169
No 151
Don't know 6
[1]
Measure Description: Do you describe yourself as ethnic Latina/Hispanic?
1.Primary Outcome
Title Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants
Arm/Group Title DR-104
Hide Arm/Group Description:
One tablet for emergency contraception
Overall Number of Participants Analyzed 343
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90.1 [1] 
(NA to 86.4)
[1]
Not part of analysis plan
2.Primary Outcome
Title Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who appropriately self-selected and used the product.
Arm/Group Title DR-104
Hide Arm/Group Description:
One tablet for emergency contraception
Overall Number of Participants Analyzed 297
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of treated participants
88.6 [1] 
(NA to 84.4)
[1]
not part of analysis plan
3.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events (TEAE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of participants who took study drug
Arm/Group Title DR-104
Hide Arm/Group Description:
One tablet for emergency contraception
Overall Number of Participants Analyzed 299
Measure Type: Number
Unit of Measure: participants
At least one TEAE 43
Withdrawn from study due to an AE 0
At least one SAE 1
4.Secondary Outcome
Title Participants Summarized by Repeat Use of Emergency Contraception (EC)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants dispensed the product
Arm/Group Title DR-104
Hide Arm/Group Description:
One tablet for emergency contraception
Overall Number of Participants Analyzed 307
Measure Type: Number
Unit of Measure: participants
Repeat uses: 0 251
Repeat uses: 1 38
Repeat uses: 2 16
Repeat uses: 3 2
Time Frame Day 1 to week 8. Unresolved AEs and pregnancies were followed until resolved.
Adverse Event Reporting Description Includes participants who took study drug. AE information was solicited during scheduled contacts on weeks 1, 4 and 8.
 
Arm/Group Title DR-104
Hide Arm/Group Description One tablet for emergency contraception
All-Cause Mortality
DR-104
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DR-104
Affected / at Risk (%)
Total   1/299 (0.33%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous   1/299 (0.33%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DR-104
Affected / at Risk (%)
Total   0/299 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00777556     History of Changes
Other Study ID Numbers: DR-LEV-302
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: September 14, 2012
Results First Posted: October 18, 2012
Last Update Posted: October 18, 2012