Estrostep (norethindrone acetate and ethinyl estradiol)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
General Information
Estrostep (ethinyl estradiol and norethindrone acetate) is
currently marketed for use as an oral contraceptive. In July 2001,
the drug received FDA approval for a new indication: the treatment
of moderate acne vulgaris (common acne) in females 15 years and
older. The drug is designed for women who have no known
contraindications to oral contraceptive therapy, and who desire
oral contraception and have not responded to topical acne
medications.
Over 20 million teenagers suffer from acne according to the
American Academy of Dermatology. Furthermore, this common skin
disease is not limited to adolescents and can affect men and women
well into adulthood. The disease causes physical effects, which may
range from moderate irritations to severe, painful lesions or
boils, and imparts a psychological and social impact that can lead
to poor self-image, embarrassment, anxiety and social
isolation.
Clinical Results
Two randomized, double-blind, placebo-controlled, multicenter
phase III trials evaluated Estrostep in the treatment of acne
vulgaris. The mean age at enrollment for both groups was 24 years,
and a total of 295 subjects received Estrostep while 296 received
placebo. At six months, results showed a statistically significant
difference between Estrostep and placebo in terms of mean change
from baseline in lesion counts. Each trial also demonstrated
overall treatment success in the investigator's global
evaluation.
Side Effects
Most side effects of oral contraceptives are not serious. The
following side effects have been reported with oral contraceptive
use and are believed to be drug-related:
- Nausea
- Vomiting
- Bleeding between menstrual periods
- Weight gain
- Breast tenderness
- Difficulty wearing contact lenses
- Migraine
- Rash
- Mental depression
- Edema (fluid retention)
Although serious side effects occur infrequently, an increased
risk of the following more severe conditions has been associated
with the use of oral contraceptives:
- Blood clots in the legs and lungs
- Heart attack
- Hypertension
- Gallbladder disease
- Liver tumors
- Stroke
As with any medication, please consult a physician for a full
list and explanation of possible adverse events.
Mechanism of Action
Acne is caused by several factors, including androgen
stimulation and sebum production. The combination of norethindrone
acetate and ethinyl estradiol increases sex hormone binding
globulin (SHBG) and decreases free testosterone; however, the
relationship between these changes and a decrease in facial acne in
otherwise healthy women has not been established. (from Estrostep
Labeling Information)
Additional Information
