Yasmin (drospirenone/ethinyl estradiol)
Company: Berlex Laboratories
Approval Status: Approved May 2001
Treatment for: Contraception
Areas: Endocrinology; Obstetrics/Gynecology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
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
Please visit Berlex Laboratories for additional information on Yasmin.
More information on contraception and related topics can be obtained through the Office of Population Affairs.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
