Effect of an oral contraceptive containing drospirenone on the renin-angiotensin-aldosterone system in healthy female volunteers.

Drospirenone is a new synthetic progestogen with both progestational, antimineralocorticoid and antiandrogenic properties. In combination with ethinylestradiol, it is being developed as an oral contraceptive which will contain 30 micrograms ethinylestradiol and 3 mg drospirenone (Yasmin, Schering AG, Germany). The effects of drospirenone alone, and in combination with ethinylestradiol, upon the renin-angiotensin-aldosterone system (RAAS) have been evaluated in healthy female volunteers. RAAS activity was assessed by measurement of plasma renin substrate (PRS) concentration (otherwise known as angiotensinogen), plasma renin activity (PRA), and plasma aldosterone (P-Aldo) concentration. An antimineralocorticoid effect was observed when volunteers received drospirenone alone at doses in the range 0.5-3.0 mg/day for one cycle. The effect was dose-dependent for P-Aldo but was not dose-dependent for PRA. When ethinylestradiol (30 micrograms) was combined with either 2 mg or 3 mg drospirenone and given to volunteers for three cycles, an increase in PRS was observed with both preparations, which was indicative of estrogenic stimulation, and increases in PRA and P-Aldo were shown which were indicative of an antimineralocorticoid effect of drospirenone. Increases in PRA and P-Aldo were significantly higher with the preparation containing 3 mg drospirenone in cycle 1 but not in cycle 3. The effect of the preparation containing 30 micrograms ethinylestradiol/3 mg drospirenone upon RAS activity was also compared with that of a commercially available preparation also containing 30 micrograms ethinylestradiol but combined with 150 micrograms desogestrel (Marvelon). Over a period of 13 cycles, increases in PRS were seen with both treatments, the effect being slightly more pronounced with 30 micrograms ethinylestradiol/150 micrograms desogestrel. A markedly greater increase in PRA was seen following treatment with 30 micrograms ethinylestradiol/3 mg drospirenone, and, in cycle 3, this difference was statistically significant. In contrast, P-Aldo was increased markedly with 30 micrograms ethinylestradiol/3 mg drospirenone in all measured cycles, whereas, in the 30 micrograms ethinylestradiol/150 micrograms desogestrel group, changes were minimal. The increases in PRA and P-Aldo are interpreted as endogenous counter-regulation against the antimineralocorticoid activity of drospirenone. PRS increases under all combinations are an expression of estrogenic stimulation. Measurement of body weight and blood pressure in the studies with combined ethinylestradiol and drospirenone revealed that drospirenone was associated with either stable body weight or with a slight loss in body weight, while blood pressure remained largely unchanged. Overall, the results indicate that 30 micrograms ethinylestradiol/3 mg drospirenone has a distinct antimineralocorticoid effect.     

A new monophasic oral contraceptive containing drospirenone. Effect on premenstrual symptoms

OBJECTIVE: To determine whether a new monophasic oral contraceptive containing drospirenone/ethinyl estradiol reduces premenstrual symptoms. STUDY DESIGN: In an open-label study measuring intrasubject changes in premenstrual symptoms and comparing effects between women who were new users of oral contraceptives and those who switched from previous contraceptives, ethinyl estradiol (30 micrograms) and drospirenone (3 mg) were administered for 13 menstrual cycles to 326 healthy women aged 18-35 years. Subjects completed the 23-item Women's Health Assessment Questionnaire at baseline and at the end of the sixth cycle. RESULTS: At the end of cycle 6, premenstrual and menstrual symptom scores on the negative affect and water retention scales were reduced significantly relative to baseline, as was increased appetite during the premenstrual and menstrual phases. Similar improvements were seen among new users of hormonal contraceptives and those who switched from previous contraceptives. Impaired concentration scale scores were not significantly reduced from baseline, and assessments of undesired hair changes and feelings of well-being did not change appreciably. CONCLUSION: An oral contraceptive containing drospirenone/ethinyl estradiol may reduce the premenstrual symptoms of negative affect, water retention and increased appetite.     

Efficacy of an oral contraceptive containing drospirenone in the treatment of women with polycystic ovary syndrome.

OBJECTIVE: To investigate the efficacy of a combined oral contraceptive containing 30 microg ethinyloestradiol and 3 mg drospirenone in the treatment of hyperandrogenism affecting women with the polycystic ovary syndrome (PCOS). METHODS: Prospective open study of 20 women for six cycles. At the beginning and at the end of the study the following values were determined: the Ferriman-Gallwey (F-G) score, body mass index, waist/hip ratio, serum levels of testosterone, SHBG, immune reactive insulin (IRI), glucose, the free androgenic index, and insulin resistance (HOMA-IR). RESULTS: All 20 women completed six cycles of therapy. The medication was well tolerated. At the end of the study there was a significant improvement of hirsutism, expressed in the decrease of the F-G score, accompanied by a decrease of testosterone and an increase of SHBG values. The carbohydrate metabolism was not affected significantly. CONCLUSION: The combined oral contraceptive containing 30 microg ethinyloestradiol and 3 mg drospirenone is an effective drug in the treatment of hyperandrogenism in women with PCOS; it elicits few side effects and does not significantly influence insulin resistance.     

Effects of an oral contraceptive containing drospirenone on bone turnover and bone mineral density

OBJECTIVE: To compare the effects of a new 21-day combined oral contraceptive containing 30 microg ethinyl/estradiol plus 3 mg drospirenone with a 21-day preparation containing 30 microg ethinyl/estradiol plus 75 microg gestodene on bone turnover and bone mineral density in young fertile women. METHODS: A randomized, controlled trial was conducted with healthy fertile women treated with 30 microg ethinyl/estradiol plus 3 mg drospirenone (group A; n = 24), 30 microg ethinyl/estradiol plus 75 microg gestodene (group B; n = 24) and healthy controls (group C, n = 23). At 3, 6, 9, and 12 months of the study, serum and urinary calcium, osteocalcin, urinary pyridinoline, and deoxypyridinoline were measured. At baseline and after 12 months, lumbar bone mineral density was determined by dual-energy X-ray absorptiometry. RESULTS: In groups A and B, urinary pyridinoline and deoxypyridinoline at 6, 9, and 12 months were significantly reduced in comparison with basal values and group C (P < .05). Pyridinoline and deoxypyridinoline levels were lower in group A than in group B throughout the study, but not significantly. In group A serum calcium levels were significantly increased after 6 months. At 12 months, no significant difference was detected in lumbar bone mineral density values among the 3 groups and in comparison with basal values. CONCLUSION: Both combined oral contraceptives exert a similar positive influence on bone turnover and bone-sparing effect in young postadolescent women.     

Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone.

OBJECTIVE: To assess the contraceptive reliability, cycle control and tolerability of a new monophasic oral contraceptive containing 30 g ethinylestradiol plus 3 mg drospirenone (Yasmin, Schering AG, Berlin, Germany), it was compared with an established oral contraceptive containing 30 g ethinylestradiol plus 150 g desogestrel (Marvelon, NV Organon, Oss, The Netherlands). METHODS: A randomized, open-label, 13-cycle study was performed at 80 European centers. Contraceptive reliability, cycle control, blood pressure, body weight, the incidence of adverse events and skin condition were assessed during 13 cycles of oral contraceptive use, and at follow-up. Subjects recorded body weight on three consecutive days pretreatment and weekly thereafter. RESULTS: Of 2069 women who started the study and received the trial preparations in a ratio of 4:1 (ethinylestradiol/drospirenone, n = 1657; ethinylestradiol/desogestrel, n = 412), 1615 completed the 13 cycles plus follow-up, providing data for over 23,000 evaluable cycles. Eleven pregnancies occurred during treatment, only one of which (in the ethinylestradiol/drospirenone group) could not be ascribed to user failure or interaction with other factors. Both preparations provided effective contraception and cycle control. Pre-existing acne and seborrhea were improved and blood pressure was essentially unchanged. The two treatments differed in their effect on body weight, the difference being statistically significant. In the ethinylestradiol/drospirenone group, there was a distinct decrease over the whole treatment phase, while a subtle and less distinct decrease was documented in the ethinylestradiol/desogestrel group. CONCLUSIONS: The combination of 30 g ethinylestradiol/3 mg drospirenone provides effective oral contraception, excellent cycle control, good tolerability and a level of weight loss that may have a significant beneficial effect on compliance in women with a tendency to weight gain due to water retention.     

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

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 microg 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 microg 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.     

Effect of an oral contraceptive containing drospirenone on the renin-angiotensin-aldosterone system in healthy female volunteers

Drospirenone is a new synthetic progestogen with both progestational, antimineralocorticoid and antiandrogenic properties. In combination with ethinylestradiol, it is being developed as an oral contraceptive which will contain 30 μg ethinylestradiol and 3 mg drospirenone (Yasmin®, Schering AG, Germany). The effects of drospirenone alone, and in combination with ethinylestradiol, upon the renin–angiotensin–aldosterone system (RAAS) have been evaluated in healthy female volunteers. RAAS activity was assessed by measurement of plasma renin substrate (PRS) concentration (otherwise known as angiotensinogen), plasma renin activity (PRA), and plasma aldosterone (P-Aldo) concentration. An antimineralocorticoid effect was observed when volunteers received drospirenone alone at doses in the range 0.5–3.0 mg/day for one cycle. The effect was dose-dependent for P-Aldo but was not dose-dependent for PRA. When ethinylestradiol (30 μg) was combined with either 2 mg or 3 mg drospirenone and given to volunteers for three cycles, an increase in PRS was observed with both preparations, which was indicative of estrogenic stimulation, and increases in PRA and P-Aldo were shown which were indicative of an antimineralocorticoid effect of drospirenone. Increases in PRA and P-Aldo were significantly higher with the preparation containing 3 mg drospirenone in cycle 1 but not in cycle 3. The effect of the preparation containing 30 μg ethinylestradiol/3 mg drospirenone upon RAS activity was also compared with that of a commercially available preparation also containing 30 μg ethinylestradiol but combined with 150 μg desogestrel (Marvelon®). Over a period of 13 cycles, increases in PRS were seen with both treatments, the effect being slightly more pronounced with 30 μg ethinylestradiol/150 μg desogestrel. A markedly greater increase in PRA was seen following treatment with 30 μg ethinylestradiol/3 mg drospirenone, and, in cycle 3, this difference was statistically significant. In contrast, P-Aldo was increased markedly with 30 μg ethinylestradiol/3 mg drospirenone in all measured cycles, whereas, in the 30 μg ethinylestradiol/150 μg desogestrel group, changes were minimal. The increases in PRA and P-Aldo are interpreted as endogenous counter-regulation against the antimineralocorticoid activity of drospirenone. PRS increases under all combinations are an expression of estrogenic stimulation. Measurement of body weight and blood pressure in the studies with combined ethinyl-estradiol and drospirenone revealed that drospirenone was associated with either stable body weight or with a slight loss in body weight, while blood pressure remained largely unchanged. Overall, the results indicate that 30 μg ethinylestradiol/3 mg drospirenone has a distinct antimineralocorticoid effect.     

Efficacy of an oral contraceptive containing drospirenone in the treatment of women with polycystic ovary syndrome

Objective To investigate the efficacy of a combined oral contraceptive containing 30 µg ethinyloestradiol and 3 mg drospirenone in the treatment of hyperandrogenism affecting women with the polycystic ovary syndrome (PCOS).

Methods Prospective open study of 20 women for six cycles. At the beginning and at the end of the study the following values were determined: the Ferriman–Gallwey (F–G) score, body mass index, waist/hip ratio, serum levels of testosterone, SHBG, immune reactive insulin (IRI), glucose, the free androgenic index, and insulin resistance (HOMA-IR).

Results All 20 women completed six cycles of therapy. The medication was well tolerated. At the end of the study there was a significant improvement of hirsutism, expressed in the decrease of the F–G score, accompanied by a decrease of testosterone and an increase of SHBG values. The carbohydrate metabolism was not affected significantly.

Conclusion The combined oral contraceptive containing 30 µg ethinyloestradiol and 3 mg drospirenone is an effective drug in the treatment of hyperandrogenism in women with PCOS; it elicits few side effects and does not significantly influence insulin resistance.     

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

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 μg 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 μg 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.     

Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone

Objective To assess the contraceptive reliability, cycle control and tolerability of a new monophasic oral contraceptive containing 30 g ethinylestradiol plus 3 mg drospirenone (Yasmin, Schering AG, Berlin, Germany), it was compared with an established oral contraceptive containing 30 g ethinylestradiol plus 150 g desogestrel (Marvelon, NV Organon, Oss, The Netherlands).

Methods A randomized, open-label, 13–cycle study was performed at 80 European centers. Contraceptive reliability, cycle control, blood pressure, body weight, the incidence of adverse events and skin condition were assessed during 13 cycles of oral contraceptive use, and at follow-up. Subjects recorded body weight on three consecutive days pretreatment and weekly thereafter.

Results Of 2069 women who started the study and received the trial preparations in a ratio of 4:1 (ethinylestradiol/drospirenone, n = 1657; ethinylestradiol/desogestrel, n = 412), 1615 completed the 13 cycles plus follow-up, providing data for over 23 000 evaluable cycles. Eleven pregnancies occurred during treatment, only one of which (in the ethinylestradiol/ drospirenone group) could not be ascribed to user failure or interaction with other factors. Both preparations provided effective contraception and cycle control. Pre-existing acne and seborrhea were improved and blood pressure was essentially unchanged. The two treatments differed in their effect on body weight, the difference being statistically significant. In the ethinylestradiol/drospirenone group, there was a distinct decrease over the whole treatment phase, while a subtle and less distinct decrease was documented in the ethinylestradiol/desogestrel group.

Conclusions The combination of 30 g ethinylestradiol/3 mg drospirenone provides effective oral contraception, excellent cycle control, good tolerability and a level of weight loss that may have a significant beneficial effect on compliance in women with a tendency to weight gain due to water retention.     

A 1-year pharmacokinetic investigation of a novel oral contraceptive containing drospirenone in healthy female volunteers.

Drospirenone is a novel synthetic progestogen with a pharmacological profile similar to that of natural progesterone. It has been developed in combination with ethinylestradiol for use as an oral contraceptive (EE/DRSP, Yasmin, Schering AG, Berlin, Germany). The pharmacokinetic characteristics of drospirenone and ethinylestradiol have been assessed in healthy female volunteers over a 1-year period. During each of the 13 treatment cycles, volunteers received the combined active ingredients for 21 days, followed by a 7-day, tablet-free interval. The concentrations of the serum proteins, sex hormone binding globulin (SHBG) and corticoid binding globulin (CBG), were determined at intervals after the cessation of treatment (day 21) at the end of cycles 1, 6, 9 and 13. Drospirenone and ethinylestradiol were found to be absorbed rapidly and to reach a peak concentration in serum 1.5-2.0 h after dosing. Serum concentrations ofdrospirenone declined, with mean terminal half-lives of 30.8-32.5 h. Accumulation of both drospirenone and ethinylestradiol was observed within a treatment cycle, with a mean accumulation ratio of 3.0 for drospirenone and 2.1 for ethinylestradiol. In addition, serum drospirenone concentrations increased between treatment cycles 1 and 6, but remained steady thereafter, as reflected in the AUC values determined at the end of treatment cycles 1, 6, 9 and 13. Serum SHBG and CBG concentrations declined in a biphasic manner after cessation of treatment at the end of cycle 13, and physiological steady-state concentrations were reached within 4-6 weeks. In conclusion, drospirenone was absorbed at a similar rate as other synthetic progestogens contained in various oral contraceptives, as indicated by similar tmax values. The terminal half-life of drospirenone was intermediate between those of 19-nortestosterone derivatives like desogestrel, levonorgestrel or gestodene and C21-progestogens like cyproterone acetate. Both active ingredients of the new contraceptive EE/DRSP showed accumulation within a treatment cycle, which is also the case with other synthetic progestogen/ethinylestradiol combinations. Similar to other oral contraceptives, a reversible induction of serum SHBG and CBG concentrations was observed under EE/DRSP treatment.     

Effect of an oral contraceptive containing ethinyl estradiol and drospirenone on premenstrual symptomatology and health-related quality of life

OBJECTIVE: To evaluate the effect of the oral contraceptive Yasmin (drospirenone, 3 mg, and ethinyl estradiol, 30 micrograms) (Berlex Laboratories, Wayne, New Jersey) on premenstrual symptomatology and health-related quality of life (HRQoL). STUDY DESIGN: Participating health care providers received 11,260 self-administered surveys for distribution to women initiating use of Yasmin. Of these, 1,932 (17.2%) baseline surveys and 1,104 follow-up surveys (57.1%) were returned, with 858 (44.4%) of the returns evaluated as suitable for analysis. RESULTS: Premenstrual symptomatology, as measured with the negative affect and water retention domains of the Moos Menstrual Distress Questionnaire (MDQ), significantly improved from baseline in all phases of the menstrual cycle (P = .000). All individual MDQ items improved significantly in the late luteal phase and during menses (P = .000), and the majority (76.9%) improved significantly in the remainder of the cycle (P < .05). Improvements were also observed in general sense of well-being (P < .05), impairment in usual activities due to premenstrual symptomatology (P < .05) and Mental Component Summary scale (P = .000) but not the Physical Component Summary scale of the Short Form-12 generic HRQoL instrument. CONCLUSION: These data support the effectiveness of Yasmin in reducing premenstrual symptomatology and improving HRQoL and general sense of well-being.     

A 1-year pharmacokinetic investigation of a novel oral contraceptive containing drospirenone in healthy female volunteers

Drospirenone is a novel synthetic progestogen with a pharmacological profile similar to that of natural progesterone. It has been developed in combination with ethinylestradiol for use as an oral contraceptive (EE/DRSP, Yasmin®, Schering AG, Berlin, Germany). The pharmacokinetic characteristics of drospirenone and ethinylestradiol have been assessed in healthy female volunteers over a 1-year period. During each of the 13 treatment cycles, volunteers received the combined active ingredients for 21 days, followed by a 7-day, tablet-free interval. The concentrations of the serum proteins, sex hormone binding globulin (SHBG) and corticoid binding globulin (CBG), were determined at intervals after the cessation of treatment (day 21) at the end of cycles 1, 6, 9 and 13. Drospirenone and ethinylestradiol were found to be absorbed rapidly and to reach a peak concentration in serum 1.5–2.0 h after dosing. Serum concentrations of drospirenone declined, with mean terminal half-lives of 30.8–32.5 h. Accumulation of both drospirenone and ethinylestradiol was observed within a treatment cycle, with a mean accumulation ratio of 3.0 for drospirenone and 2.1 for ethinylestradiol. In addition, serum drospirenone concentrations increased between treatment cycles 1 and 6, but remained steady thereafter, as reflected in the AUC values determined at the end of treatment cycles 1, 6, 9 and 13. Serum SHBG and CBG concentrations declined in a biphasic manner after cessation of treatment at the end of cycle 13, and physiological steady-state concentrations were reached within 4–6 weeks.

In conclusion, drospirenone was absorbed at a similar rate as other synthetic progestogens contained in various oral contraceptives, as indicated by similar t_max values. The terminal half-life of drospirenone was intermediate between those of 19-nortestosterone derivatives like desogestrel, levonorgestrel or gestodene and C21-progestogens like cyproterone acetate. Both active ingredients of the new contraceptive EE/DRSP showed accumulation within a treatment cycle, which is also the case with other synthetic progestogen/ethinylestradiol combinations. Similar to other oral contraceptives, a reversible induction of serum SHBG and CBG concentrations was observed under EE/DRSP treatment.     

Influence of a new oral contraceptive with drospirenone on lipid metabolism.

The present study aimed to evaluate the effect of an oral contraception formulation with drospirenone (Yasmin) on lipid metabolism. An open-label, non-comparative clinical trial was conducted. One hundred women, who desired oral contraception for at least 6 months, were recruited. The subjects received a blister pack which contained 21 tablets of 3 mg drospirenone/30 mug ethinyl estradiol for the first four cycles (1 cycle = 28 days). Cycle 5 and 6 blister packs were dispensed during the next visit in cycle 4. Serum from each subject was collected and analyzed for lipid profile levels at baseline and at cycle 6. The mean differences in lipid profile levels at cycle 6 compared with baseline were assessed. Of the total 100 subjects, 92 (92%) completed the study. There was no significant change in total cholesterol. At cycle 6, high-density lipoprotein cholesterol (HDL-C) and triglycerides increased significantly by 25.7% and 42.0%, respectively, compared with baseline. However, low-density lipoprotein cholesterol (LDL-C) decreased significantly by 9.9% at cycle 6 compared with baseline. Our results show that the new oral contraception formulation with drospirenone (Yasmin) is well tolerated and has good contraceptive efficacy. The observed favorable changes in HDL-C and LDL-C suggest a potential cardioprotective benefit.     

Psychological effect of the oral contraceptive formulation containing 3 mg of drospirenone plus 30 microg of ethinyl estradiol

OBJECTIVE: To investigate in healthy eumenorrheic young women whether an oral contraceptive (OC) containing drospirenone (DRSP) (3 mg) + ethinyl estradiol (EE) (30 microg) (DRSP + EE) could modify psychological symptoms and whether it could modify steroids interfering with the gamma-aminobutyric acid (GABA)-A receptors. DESIGN: Clinical study of treated subjects and nontreated controls. SETTING: Healthy volunteers in the Department of Obstetrics and Gynecology at Cagliari University. PATIENT(S): Control group (n = 12) and OC group (n = 10) women with similar age, body mass index, and main outcome measures. INTERVENTION(S): The control group was studied during the first menstrual cycle at the follicular phase (FP) and at the luteal phase (LP) and during the third cycle at the LP; the OC group was studied during the first cycle, as described above, and on day 16-18 of the third cycle of treatment with DRSP + EE. MAIN OUTCOME MEASURE(S): Psychometric scale (SCL-90), DHEAS, P, allopregnanolone (AP), and allotetrahydrodeoxy-corticosterone (THDOC). RESULT(S): SCL-90 and DHEAS did not vary throughout the menstrual cycle. P, AP, and THDOC values were higher during the LP than the FP. At the third cycle, in the control group the main outcome measures were similar to those at LP. In the OC group, the SCL-90 global score, the intensity of anxiety and phobic anxiety, the levels of anxiolytic steroids (P, AP, THDOC) and the anxiety-inducing steroid DHEAS were reduced. CONCLUSION(S): The results suggest beneficial effects of DRSP + EE on psychological symptoms by decreasing DHEAS.     

New combined oral contraceptive with incremental progestogen dosage regimen.

In a study of 506 women, 272 took a total of 2124 cycles of combined preparations of norgestrel and 234 women took a total of 2002 cycles of a combined contraceptive with incremental progestogen doses, in which the total D-norgestrel was 1800 g as opposed to 5250 g in the combined preparation. The step-up preparation group had a similar rate of side effects as the combined preparation group; however, women using the step-up preparation had significantly diminished intermenstrual bleeding after the 6th month of use. The step-up regimen has not induced any cases of endometrial hyperplasia but does have an inhibiting effect on endometrial proliferation in the 1st half of the cycle. The step-up preparation has similar effects on the hypothalamo-hypophysial-ovarian axis as the combined pill. The step-up preparation appears to inhibit ovulation from the 1st cycle as indicated by the absence of LH and FSH midcycle peaks and the low 17 beta-estradiol levels in the 2nd half of the cycle; therefore, the step-up preparation should be classified as a new combined, not sequential, oral contraceptive.