Ethinylestradiol/Drospirenone: A Review of its Use as an Oral Contraceptive

Authors: Keam S.J.; Wagstaff A.J.

Source: Treatments in Endocrinology, Volume 2, Number 1, 2003 , pp. 39-61(23)

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Abstract:

Ethinylestradiol 30g/drospirenone 3mg (Yasmin, petibelle ) [EE/DRSP] is a combined contraceptive pill (CC) for the prevention of pregnancy in women of reproductive age. Drospirenone is a novel progestogen with antimineralocorticoid, progestogenic and antiandrogenic activity.

The theoretical (0 to 0.07) and corrected (0.41 to 0.71) Pearl indices and pregnancy ratios (0.3 to 0.84) in young, healthy women aged 18 to 35 years (or 18 to 30 years if smokers) given 13 to 26 cycles of EE/DRSP in large multicenter trials indicate that this CC is highly effective in preventing pregnancy. EE/DRSP is equally as effective as ethinylestradiol 30g/desogestrel 150g (EE/DSG; corrected Pearl index 0.28 to 0.41) in preventing pregnancy.

EE/DRSP is generally well tolerated. The frequency and type of adverse event reported in clinical trials are typical of those observed with other CCs, and comparable to those in women receiving EE/DSG.

The incidence of intermenstrual bleeding (spotting, breakthrough bleeding or both) during treatment with EE/DRSP in young, healthy women decreased rapidly after the first cycle to 9 to 18% in the second cycle and 6% after 26 cycles, indicating good cycle control. The incidence of intermenstrual bleeding was similar in recipients of EE/DSG (9 and 14% in cycle 2 and 10% in cycle 26).

Bodyweight was maintained ±2kg in most young women who received EE/DRSP for up to 26 cycles. Neither EE/DRSP nor EE/DSG showed clinically significant effects on blood pressure.

EE/DRSP improved premenstrual and menstrual symptoms (negative affect, water retention, increased appetite) compared with baseline in a noncomparative trial. A similar improvement in skin condition (acne, seborrhea) was observed in women receiving EE/DRSP or ethinylestradiol 35g/cyproterone acetate 2mg in a randomized, double-blind trial.

Conclusions: Data from several 1- to 2-year studies show that EE/DRSP is an effective oral contraceptive, with Pearl index values similar to those of established low-dose CCs. This combination is well tolerated, demonstrating good cycle control and a beneficial effect on skin condition and well-being (including some premenstrual and menstrual symptoms). EE/DRSP has demonstrated similar efficacy and tolerability to EE/DSG, but long-term clinical experience is required to establish the position of EE/DRSP among other available CCs and to clarify any potential tolerability advantages. Nevertheless, because the management of tolerability is complicated by the idiosyncratic nature of the response of women to CCs containing different progestogens, EE/DRSP appears to be a useful treatment option for women desiring oral contraception.

Keywords: Adis Drug Evaluations; Contraception; Ethinylestradiol/drospirenone, general; Oral contraceptives, general; Pregnancy, prevention

Language: English

Document Type: Drug Evaluation

Affiliations: 1: Adis International Inc., Langhorne, Pennsylvania, USA *

Publication date: 2003-01-01

Ethinylestradiol/Drospirenone: A Review of its Use as an Oral Contraceptive

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