Once a week.1
Indications for Climara Pro® (estradiol/levonorgestrel transdermal system)
In women with an intact uterus:
- Climara Pro is indicated for treatment of moderate to severe vasomotor symptoms due to menopause.1
- Climara Pro is also indicated for the prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.1
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- Applied to the skin once weekly1
- Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to discontinue the medication should be made at 3- to 6-month intervals.
- Provides a nominal delivery rate (mg per day) of 0.045 estradiol and 0.015 levonorgestrel1
- In a clinical study, Climara Pro provided clinically acceptable adhesion1
- A study of the adhesion potential of Climara Pro was conducted in 104 healthy women of 45–75 years of age. Each woman applied a placebo patch, containing only the Climara Pro adhesive without active ingredient, to the upper outer abdominal areas weekly for three weeks. The adhesion assessment was done visually on Days 2, 4, 5, 6 and 7 of each of the three weeks using a four-point scale. The mean scores ranked in the highest category possible on the 0 to 4 scale demonstrating clinically acceptable adhesion performance.
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Demonstrated Efficacy in Clinical Trials
Fewer and less severe hot flushes compared to placebo at 4 weeks
The efficacy of 0.045 mg estradiol(E2)/0.03 mg levonorgestrel(LNG) administered weekly versus placebo in the relief of moderate to severe vasomotor symptoms in postmenopausal women was studied in one 12-week clinical trial (n=183, average age 52.1 ± 4.93 percent Caucasian). The 0.045 mg estradiol/0.03 mg levonorgestrel dosage strength† was shown to be statistically better than placebo at weeks 4 and 12 for relief of both the number and severity of moderate to severe hot flushes.1
Summary of Mean Daily Number of Moderate to Severe Hot Flushes-ITTa
- At baseline, the mean number of moderate to severe hot flushes was 10.13 per day for the treatment group (nb=92) and 10.8 for placebo (nb=88).
- At week 4, the mean number of moderate to severe hot flushes was 2.69 per day for the treatment group (nb=88) and 6.13 for placebo (nb=82) (p<0.001).c
- At week 8, the mean number of moderate to severe hot flushes was 1.22 per day for the treatment group (nb=80) and 5.35 for placebo (nb=73).
- At week 12, the mean number of moderate to severe hot flushes was 1.06 per day for the treatment group (nb=73) and 5.59 for placebo (nb=69) (p<0.001).c
Summary of Mean Severityd of Moderate to Severe Hot Flushes-ITTa
- At baseline, the mean severity of moderate to severe hot flushes was 2.48 per day for the treatment group (nb=92) and 2.42 for placebo (nb=89).
- At week 4, the mean severity of moderate to severe hot flushes was 1.1 per day for the treatment group (nb=83) and 1.99 for placebo (nb=76) (p<0.001).c
- At week 8, the mean severity of moderate to severe hot flushes was 0.82 per day for the treatment group (nb=72) and 1.93 for placebo (nb=68).
- At week 12, the mean severity of moderate to severe hot flushes was 0.44 per day for the treatment group (nb=55) and 1.8 for placebo (nb=57) (p<0.001).c
The most common adverse reactions (≥5%) in clinical trials were: application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, and headache.All treatment emergent reactions regardless of relationship reported at a frequency of >3% with Climara Pro in the 1-year endometrial hyperplasia study with Climara Pro 0.045 / 0.015 (N = 212)
Adverse Reactions: Application site reaction (40.6%), Vaginal bleeding (36.8%), Breast pain (18.9%), Upper respiratory infection (13.2%), Back pain (6.1%), Depression (5.7%), Headache (5.2%), Pain (5.2%), Flu syndrome (4.7%), Abdominal pain (4.2%), Arthralgia (4.2%), Bronchitis (4.2%), Edema (3.8%), Flatulence (3.8%), Sinusitis (3.8%), Accidental injury (3.3%), Hypertension (3.3%), Infection (3.3%), Urinary tract infection (3.3%).