Dosage and administration
This is when a woman with no current use of a hormonal contraception should begin Twirla.
During 1st 24 hours of menstruation
Section 2.1 table 1, "dosage and administration"
This % of women in the secure trial experienced headache.
3.6%
section 6.1 table 3, "adverse reactions"
This is how big the patch is.
28 cm squared
Section 16.1, under “How Supplied/Storage and Handling”
In the year-long trial, this is the amount of TDS’s that became fully detached.
5%
Section 14, under "Clinical Studies"
This is when a woman should begin Twirla if previously used a vaginal ring.
Complete current vaginal ring cycle and apply the first Twirla TDS on the next day the vaginal ring would normally be inserted.
Section 2.1 table 1, "dosage and administration"
Based on electronic patient diaries, these are the percentages of women with no bleeding and/or spotting days in cycle 1 to cycle 13.
11.9%, 6.3%
Section 5.9, "warnings and precautions"
Even though all 3 areas of application are therapeutically equivalent, in studies, this area had slightly lower absorption than the other two sites.
abdomen
Sec. 12.3, under “Clinical Pharmacology”
This is the % of subjects in the secure trial that had a BMI greater than or equal to 30.
35.3%
Section 14, "clinical studies"
This is how long you have to wait to start Twirla after pregnancy? (If not breastfeeding)
Do not start sooner than 4 weeks after childbirth
Section 2.1, "dosage and administartion"
This % of women discontinued the study prematurely due to menstrual disorders.
2.2%
Section 5.9, "warnings and precautions"
Twirla is not advised to use during breastfeeding because of this.
Contraceptive hormones are present in human milk. CHCs can reduce milk production in breastfeeding women.
Section 8.2, "use in specific populations"
This is the number of evaluated cycles in the PI efficacy analysis for those with a BMI less than 25?
6007
Section 14 table 7, "clinical studies"
If patch is detached for more than 24 hours or unsure the duration does this result in a new TDS change day? Start a new cycle? Backup contraception required?
Yes, yes, yes
Section 2.3 table 2, "dosage and administration"
This is how many women experienced breakthrough bleeding at cycle 1 in clinical trials, and this is how many experienced it at cycle 13.
60.4% and 42.3%
Sec. 5.9, under “Warnings and Precautions”
Twirla should be stored at this room temperature.
68 to 77 degrees F
section 16.1, "how supplied/storage & handling"
This is the number of patients enrolled versus evaluated in the secure trial.
2031/1736
section 14, "Clinical Studies"
This is how long a woman has to change her patch if she forgets to change it in the middle of her cycle (week 2 or week 3)
48 hours
Section 2.3, under “Dosage and Administration”
These were the two main reasons why women dropped out of the SECURE trial.
Woman’s decision and lost to follow-up
Sec. 6.1, under “Adverse Reactions"
Following application of Twirla, both LNG and EE reach a plateau by this time.
24 to 48 hours
section 12.3, "clinical pharmacology"
This area showed the best adhesion in the clinical trials compared to the other two areas.
abdomen
Section 14, under "Clinical Studies"