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Suppression of ovarian activity with a drospirenone-containing oral contraceptive in a 24/4 regimen.
Contraception. 2008 Jul; 78(1): 16-25
Klipping C, Duijkers I, Trummer D, Marr J
BACKGROUND: This study was conducted to compare ovarian activity of an oral contraceptive containing drospirenone (drsp) 3 mg plus ethinylestradiol (EE) 20 mcg administered in 24/4 regimen compared with the conventional 21/7 regimen, during intended use and following predefined dosing errors. STUDY DESIGN: Women aged 18-35 years who ovulated or had a follicular diameter of >/=15 mm on or before Day 23 during a pretreatment cycle were admitted into this double-blind, randomized study. Participants underwent 3 treatment cycles with drsp 3 mg/EE 20 mcg in a 24/4 (n=52) or a 21/7 (n=52) regimen. In the third treatment cycle, the initial three pills in both groups were replaced with placebos. Ovarian activity was classified using the Hoogland scale during pretreatment and during Cycles 2 and 3. RESULTS: Suppression of ovarian activity was more pronounced with the 24/4 regimen - the odds ratio for a lower Hoogland score (i.e., greater ovarian suppression) with the 24/4 regimen compared with the conventional 21/7 regimen were 6.01 (95% CI: 2.29-17.94) and 3.06 (95% CI: 1.44-6.65) for Cycles 2 and 3, respectively. More women in the 24/4 regimen group had no ovarian activity 87.8% vs. 56.0% during Cycle 2 and 55.1% vs. 30.0% during Cycle 3. The 24/4 regimen was associated with a more consistent suppression (less fluctuation) of endogenous estradiol. CONCLUSION: The drsp 3 mg/EE 20 mcg oral contraceptive in a 24/4 regimen was associated with greater ovarian suppression (despite intentional dosing error), which results in decreased hormonal fluctuations, and may increase contraceptive efficacy with the low-dose formulation.
Contraception. 2008 Jul; 78(1): 10-5
Gargano V, Massaro M, Morra I, Formisano C, Di Carlo C, Nappi C
BACKGROUND: The effects of a 21-day combined oral contraceptive containing 30 mcg ethinyl estradiol plus 3 mg drospirenone with a 21-day preparation containing 20 mcg ethinyl estradiol plus 3 mg drospirenone on bone turnover and bone mineral density (BMD) in young fertile women were compared. METHODS: A randomized, controlled trial was conducted on healthy fertile women treated with 30 mcg ethinyl estradiol plus 3 mg drospirenone (Group A; n=21), 20 mcg ethinyl estradiol plus 3 mg drospirenone (Group B; n=23) and healthy controls (Group C; n=21). At 3, 6, 9 and 12 months, serum and urinary calcium, osteocalcin (BGP), 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
Menopause. 2008 Jun 10;
Caruso S, Serra A, Grillo C, De Leo V, Maiolino L, Agnello C, Cianci A
OBJECTIVE:: To evaluate the effects of drospirenone on the olfactory sensitivity in postmenopausal women treated with hormone therapy (HT). DESIGN:: Forty-seven naturally postmenopausal women participated in the prospective study. The women underwent continuous combined HT containing 1 mg 17beta-estradiol and 2 mg drospirenone (DRSP). Airflow resistance values and olfactometric thresholds were measured by using rhinomanomety and olfactometry, respectively, performed at baseline and in the third and sixth cycle of HT. RESULTS:: Rhinomanometric values were better during 17beta-estradiol/DRSP HT with respect to those observed at baseline (P < 0.001). Olfactometric threshold data indicated a higher sensitivity during both the third (P < 0.05), and sixth cycles of 17beta-estradiol/DRSP HT (P < 0.001) than at baseline. CONCLUSIONS:: Our study confirmed that the nasal airflow resistance and olfactory thresholds to odors may depend on steroid hormones. We believe that estrogens could influence neuronal plasticity and the neuronal conduction time in the olfactory system. The antimineralocorticoid activity of DRSP may produce a decrease in nasal edema, inducing a better interaction between odorous substances with receptors.
Minerva Ginecol. 2008 Jun; 60(3): 239-243
Lello S, Primavera G, Colonna L, Vittori G, Guardianelli F, Pallotta P, Sorge R, Bilchugova E, Raskovic D
AIM: This study evaluated hormonal and skin effects in hyperandrogenic women of an oral estroprogestin (EP) association containing ethynilestradiol 30 mcg plus drospirenone 3 mg. METHODS: Thirty two women with signs and symptoms of hyperandrogenism (seborrhea, acne, increased hair); hormonal assessment (follicle-stimulating hormone, [FSH]; luteinizing hormone, LH; 17-hydroxi-progesterone, 17OHP; androstenedione, A, testosterone, T; dehydroepiandrosterone sulfate, DHEAS; sex hormone binding globulin, [SHBG]; Free Androgen Index [FAI, Tx100/SHBG] was performed before the start of treatment, and after 3 and 6 months of administration of EP. The impact on seborrhea, acne, and hair pattern (Ferriman-Gallwey score) was assessed, and, by non-invasive technique, hydration, water transpiration, and homogeneity of the skin were evaluated. RESULTS: Treatment with this EP for 6 months decreased significantly circulating androgen levels (A, T, DHEAS) and FAI, and increased SHBG levels, also reducing seborrhea, acne and hirsutism. Moreover, EE/DRSP increased hydration and improved overall appearance of skin surface (homogeneity). CONCLUSION: Treatment with EE 30 mcg+DRSP 3 mg improves hormonal pattern and skin appearance in hyperandrogenic patients, potentially with subsequent, beneficial effects on quality of life of these women.
BMC Cancer. 2008 Jun 9; 8(1): 166
Xiao-Dong F, Giretti MS, Goglia L, Flamini MI, Sanchez AM, Baldacci C, Garibaldi S, Sitruk Ware R, Genazzani AR, Simoncini T
ABSTRACT: BACKGROUND: Limited information is available on the effects of progestins on breast cancer progression and metastasis. Cell migration and invasion are central for these processes, and require dynamic cytoskeletal and cell membrane rearrangements for cell motility to be enacted. METHODS: We investigated the effects of progesterone (P), medroxyprogesterone acetate (MPA), drospirenone (DRSP) and nestorone (NES) alone or with 17beta-estradiol (E2) on T47-D breast cancer cell migration and invasion and we linked some of these actions to the regulation of the actin-regulatory protein, moesin and to cytoskeletal remodeling. RESULTS: Breast cancer cell horizontal migration and invasion of three-dimensional matrices are enhanced by all the progestins, but differences are found in terms of potency, with MPA being the most effective and DRSP being the least. This is related to the differential ability of the progestins to activate the actin-binding protein moesin, leading to distinct effects on actin cytoskeleton remodeling and on the formation of cell membrane structures that mediate cell movement. E2 also induces actin remodeling through moesin activation. However, the addition of some progestins partially offsets the action of estradiol on cell migration and invasion of breast cancer cells. CONCLUSIONS: These results imply that P, MPA, DRSP and NES alone or in combination with E2 enhance the ability of breast cancer cells to move in the surrounding environment. However, these progestins show different potencies and to some extent use distinct intracellular intermediates to drive moesin activation and actin remodeling. These findings support the concept that each progestin acts differently on breast cancer cells, which may have relevant clinical implications.
J Eur Acad Dermatol Venereol. 2008 Jun 4;
Ozdemir S, Ozdemir M, Toy H
Exp Clin Psychopharmacol. 2008 Apr; 16(2): 156-64
Wharton W, Hirshman E, Merritt P, Doyle L, Paris S, Gleason C
The current study investigated whether the androgenic activity of oral contraceptives (OC) mediates performance on sexually dimorphic cognitive tasks in 155 younger individuals. Participants were categorized by hormonal contraceptive use (user vs. nonuser) and the androgenic activity of each OC (OC generation). OC generation was determined based on previous research in which users are grouped based on the type of progestin contained in each OC. Cognitive tasks included the mental rotation task (MRT) and a recognition memory task. In addition, we examined the correlates of both menstrual cycle phase and OC use, such as mood, premenstrual syndrome, depression, blood pressure, and body fat using standardized measures. The main result was that OC androgenicity influenced MRT performance. Second generation OCs are the most androgenic. Thus, MRT performance was best in these OC users as compared to third generation users, Yasmin users and nonusers. On the other hand, Yasmin, a newer generation of OC, contains an "antiandrogenic" progestin, dropirenone. Yasmin users not only performed more poorly on the MRT in comparison to second and third generation pill users, but they performed significantly worse than OC nonusers. Results show that the androgenic activity in OCs influences MRT performance in the presence of static estrogen levels. Overall, the resulting pattern is consistent with a broad range of results demonstrating that visuospatial performance may be enhanced in women who are exposed to androgenic treatments. Furthermore, visuospatial performance is hindered with the introduction of antiandrogenic preparations.
Protein Pept Lett. 2008; 15(4): 402-10
Saleem M, Akhtar MS, Yasmin R, Zahid M, Malik NN, Afzal M, Rajoka MI
Bacillus strain CTP-09 yielded maximum productivity (1120 IU/L.h) of extracellular endoglucanase (CMCase) on 0.5% cellobiose after 10 h fermentation at 55 degrees C. The purified enzyme is mono-meric in nature and exhibits stability up to 80 degrees C and over a pH range (6.0-9.0). Activation energy, enthalpy and entropy of catalysis, and inactivation indicated that this CMCase is highly thermos-table. Purified enzyme possessed high power of defibrillation of textile and was minutely inhibited by anionic detergent and oxidizing agent comparable with inhibition by commercial enzyme. This polypeptide could be exploited for mass production and application in local industries.
Ther Clin Risk Manag. 2007 Aug; 3(4): 585-90
De Berardis D, Serroni N, Salerno RM, Ferro FM
Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome (PMS). Pharmacologic options studied for treating severe PMS and PMDD may include selective serotonin reuptake inhibitors, anxiolytic agents, gonadotropin-releasing hormone agonists and the diuretic spironolactone. However, the use of combined oral contraceptives (COC) may be a therapeutic option in treating PMS and PMDD. The combination of drospirenone with ethinylestradiol (EE/drospirenone) was approved for marketing as an oral contraceptive in Europe and the United States. The preparation is characterized by a high contraceptive efficacy in combination with excellent cycle control, good tolerability, and a favourable impact on lipid and glucose metabolism. Recently, some placebo-controlled, randomized studies have tested clinical efficacy and tolerability of this COC in the treatment of PMDD. The aim of the present review was to elucidate the possible benefits or disadvantages of PMDD treatment with this novel formulation of EE/drospirenone. The results of trials evaluating the use of EE/drospirenone combination in the treatment of PMDD are encouraging but further studies are needed. However, the reported clinical efficacy and the relative good tolerability of EE/drospirenone may contribute to widen the therapeutic spectrum of PMDD.
Clinical experiences with drospirenone: From reproductive to postmenopausal years.
Maturitas. 2008 Jun 20; 60(2): 78-91
Pérez-López FR
OBJECTIVE: To review the scientific publications concerning the clinical use of drospirenone (DRSP) as the progestin in combined oral contraceptives (OCs), and as hormone treatment for menopause. METHODS: This is a retrospective study of published information concerning DRSP retrieved from both a PubMed and a personal search. RESULTS AND DISCUSSION: DRSP is a progestin with antimineralocorticoid and antiandrogenic activities that confer special clinical relevance. The OC containing ethinyl estradiol (either 30 or 20mug/day) and DRSP (3mg) has been shown to be highly efficacious and to provide safety equivalent to that of other OC formulations. These OCs appear to improve many of the symptoms associated with premenstrual complaints and dysphoric disorders, including negative mood, water retention and increased appetite. The comparative safety and efficacy of newer OC formulations is difficult to establish since only a few randomized controlled trials have compared newer OCs in a head-to-head manner, and because pregnancy rates with today's OCs are so low that demonstrating a significant difference in efficacy would require very large sample sizes. The combined daily administration of DRSP and estradiol valerate has been reported to reduce most of the frequent climacteric symptoms and to provide a slight reduction in blood pressure, preventing fluid retention and hypertension. The unwanted effects related with DRSP are minor and not medically serious. Therefore, the follow-up rate is high in both OC and menopause treatments.