IngentaConnect Effect of an oral contraceptive containing drospirenone and ethin...

Abstract:

Oral contraception is the most widely used reversible contraceptive method. Continuous research over the past decades has led to a range of highly reliable, effective and safe oral contraceptives. Newly developed progestogens may also provide additional non-contraceptive health-related benefits that differentiate the products from each other. Women desiring contraception may thus choose from a wide range of oral contraceptives according to their individual needs. A variety of physical and emotional changes have been linked to hormonal fluctuations during the menstrual cycle. To date, only very few studies have been performed on the impact of fluid retention-related symptoms on well-being and few data are hence available on suggested methods of measurement. This open, multicenter, uncontrolled study evaluated the effects of a combined preparation containing 3 mg drospirenone and 30

g ethinylestradiol (Yasmin^®, Schering AG, Berlin, Germany) on general well-being and fluid-related symptoms in women experiencing psychological, behavioral and somatic premenstrual symptoms. The study was conducted over six 28-day cycles, with 336 subjects enrolled. A significant beneficial effect on psychological general well-being, as measured by the Psychological General Well-Being Index (PGWBI), was evident by cycle 3 and maintained at cycle 6. There was a significant reduction in both the incidence and severity of somatic symptoms associated with the menstrual cycle (abdominal bloating and breast tension) during treatment. Assessment by the investigator showed that 80% of subjects had improved on study treatment and 75% of subjects considered themselves satisfied with the study treatment. There was good agreement between the clinician and subject in their assessment of the treatment. Cycle control was very good and body weight remained stable or decreased slightly during the study. In conclusion, 3 mg drospirenone in combination with 30

g ethinylestradiol has been shown to have a beneficial effect on psychological general well-being, as measured by the PGWBI. Reductions in the incidence and severity of somatic symptoms associated with the menstrual cycle were also observed, suggesting a beneficial effect due to the antimineralocorticoid nature of drospirenone. To our knowledge, this is the first study on oral contraceptives which has used the PGWBI in this population. As quality of life is one of the least explored segments in oral contraceptive users, more studies should investigate the impact of oral contraceptives on quality of life and general well-being in this overall healthy population.

Keywords: DROSPIRENONE; ETHINYLESTRADIOL; WELL-BEING; ORAL CONTRACEPTIVES; PSYCHOLOGICAL GENERAL; WELL-BEING INDEX; ABDOMINAL BLOATING; BREAST TENSION; BLOOD PRESSURE; HEART RATE; BODY; WEIGHT; SOMATIC SYMPTOMS; QUALITY OF LIFE

Document Type: Original article

Affiliations: 1: The Family Federation of Finland, Helsinki, Finland 2: University of Debrecen Medical and Health Science Center, Clinic of Gynecology and Obstetrics, Debrecen, Hungary 3: Aschaffenburg, Germany 4: Institute of Obstetrics and Gynecology, Università degli Studi Ospedale, San Giovanni di Dio, Cagliari, Italy 5: Paris, France 6: Outcomes Research Department, Schering AG, Berlin, Germany 7: Medical Department, Schering Health Care Ltd., Burgess Hill, UK

Effect of an oral contraceptive containing drospirenone and ethinylestradiol on general well-being and fluid-related symptoms