General Information

Yasmin (drospirenone/ethinyl estradiol) 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.

Yasmin is specifically indicated as a female contraceptive.

Yasmin is supplied as an oral tablet. The first course of Yasmin is started on the first day of the menstrual period (day 1 of the cycle). from the silver section of the pack by selecting the appropriate tablet for that day of the week (e.g. "MO" for Monday). The tablet is swallowed whole with some liquid. Thereafter one tablet must be taken daily for 28 days following the direction shown by the arrows. It does not matter at what time of the day the tablet is taken, but once the patient has selected a particular time, the tablet should be taken as near as possible at the same time each day. Withdrawal bleeding usually starts on day 2 to 3 after starting the inactive (hormone-free) tablets and may not have finished before the next pack is started. Each subsequent pack is started the day after the last tablet of the current pack. If a patient starts Yasmin during the latter part of the week, the very first cycle may be slightly shortened.

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)

Side Effects

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

Clinical Trial 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.