New combined oral contraceptive containing drospirenone and changes in body weight during six usage cycles

New combined oral contraceptive containing drospirenone and changes in

body weight during six usage cycles

D. Driák (1), Z. Tömölová (2)

Department of Gynaecology and Obstetrics of the 1st Medical Faculty of

Charles University and Teaching Hospital Na Bulovce, Prague, Czech Republic (1);

GynCentrum, s.r.o., Prague, Czech Republic (2)

Introduction: One of the most frequent reasons for discontinuing oral

contraception (OC) from the side of patients is weight gain. Drospirenone (DRSP)

is the only progestin whose mild antimeneralocorticoid effect makes it more

similar to the endogenous progesterone than any other syntetic gestogen

currently available. DRSP is able to eliminate the weight-increasing effect of

estrogens. Its acceptability comes from the unique progesterone-like

pharmacological profile of the progestin component derived from 17-spirolactone.

Objectives: The purpose of this study was to observe the changes in

body weight during 6 usage cycles of the new OC containing 30 µg of

ethinylestradiol and 3000 µg of drospirenone in one tablet (Yadine).

Design & Methods: From June 2003 until January 2004, in 110 women

between 15 and 46, changes in body weight, BMI and girt measurement were

observed. Side effects and reasons for discontinuation were analysed.

Results: One patient (0,9 %) stopped using Yadine in the first month

of usage because of pains in the calves and a feeling of languor, the other 109

patients (99,1 %) finished 6 cycles. The contraceptive’s reliability was

absolute. During 6 usage cycles of Yadine, the mean body weight dropped from

60,5 to 59,6 kg, the BMI decreased very slightly from 21,9 to 21,6 kg/m2 and

girt circumference decreased from 61,5 to 60,2 cm. Breakthrough bleeding occured

in only 2 cases (1,8 %) in the first 3 months.

Conclusions: According to the results of this prospective study, in

654 cycles the OC containing 30 µg of EE and 3000 µg of DRPS is tolerated very

well. Body weight, BMI and girt circumference remain stable or are slightly,

non-significantly decreased. There were no serious life threatening adverse

events, in one patient pains in calves indicated the risk of possible of

thrombosis and using of OC was stopped.

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