Yasmin (drospirenone/ethinyl estradiol)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
General Information
Yasmin (drospirenone/ethinyl estradiol) has been approved by the
FDA for the prevention of pregnancy in women who elect to use an
oral contraceptive. Yasmin is a low-dose, monophasic oral
contraceptive that contains the unique progestin, drospirenone.
Drospirenone, an analogue of spironolactone, differs from
progestins currently available in other oral contraceptives by
exhibiting both antimineralocorticoid and antiandrogenic effects.
Yasmin combines this unique progestin with ethinyl estradiol.
Clinical Results
The effectiveness and safety of Yasmin was established in
large-scale clinical trials of up to two years duration. These
trials included 2,629 women who completed 33,160 cycles of use
without any other contraception. The mean age of the subjects was
25.5 ± 4.7 years, and the age range was 16-37 years. Results showed
that Yasmin provided cycle control with a low rate of spotting and
breakthrough bleeding. The drug proved more than 99% effective in
preventing pregnancy, with only one pregnancy occurring in 3,201
cycles of 326 Yasmin users.
Side Effects
Drospirenone exhibits antimineralocorticoid activity that
influences the regulation of water and electrolyte balance in the
body. Because this activity may increase potassium levels, Yasmin
should not be used by women with kidney, liver or adrenal
disease.
The following list includes, but is not limited to, the most
common adverse events reported with Yasmin use during clinical
trials (occuring in greater than 1% of subjects, and which may or
may not be drug related):
- Headache
- Breast pain
- Abdominal pain
- Nausea
- Flu syndrome
- Acne
- Depression
- Diarrhea
- Dysmenorrhea (pain during menstruation)
- Back pain
- Infection
- Dizziness
- Nervousness
- Vaginitis
- Sinusitis
- Urinary tract infection
- Rash
In general, the following adverse reactions have been reported
in patients receiving oral contraceptives and are believed to be
drug related:
- Nausea
- Vomiting
- Bleeding between menstrual periods
- Weight gain
- Breast tenderness
- Intolerance to contact lenses
Mechanism of Action
Combination oral contraceptives (COCs) act by the suppression of
gonadotropins. Although the primary mechanism of this action is
inhibition of ovulation, other alterations include changes in the
cervical mucus (which increases the difficulty of sperm entry into
the uterus) and the endometrium (which reduces the likelihood of
implantation).
Drospirenone is a spironolactone analogue with
antimineralocorticoid activity. Preclinical studies in animals and
in vitro have shown that drospirenone has no androgenic,
estrogenic, glucocorticoid and antiglucocorticoid activity.
Preclinical studies in animals have also shown that drospirenone
has antiandrogenic activity. (from Yasmin Prescribing
Information)
Additional Information
