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The effect of a phasic oral contraceptive containing Desogestrel on seborrhea and acne.

OBJECTIVE: To investigate the effect of an oral contraceptive (Novial) on facial seborrhea and moderate acne. METHODS: In this nonrandomized, group-comparative trial, women aged between 18 and 30 with seborrhea were enrolled. Women used either a phasic oral contraceptive containing ethinylestradiol (35/30/30 microg) and Desogestrel (50/100/150 microg (DSG-OC)) (n = 177) or no hormonal treatment (control group; n = 77) for four cycles. RESULTS: Overall, 161 subjects (90.9%) in the DSG-OC group and 73 subjects (94.4%) in the control group completed the study. In the DSG-OC group, the total score for sebum excretion decreased by 0.71 nL/cm(2) (95% CI 0.36-1.05). In the control group, sebum excretion increased by 0.05 nL/cm(2) (-0.55 to 0.46). The difference between groups (0.78 nL/cm(2) (0.19-1.36)) was statistically significant (P = 0.010). The number of active follicles/cm(2) decreased by 0.86 (0.44-1.28) and 0.08 (-0.53 to 0.69), respectively (P = 0.029). The difference in qualitative scores between the groups (0.93 (0.08-1.78)) was statistically significant ( P = 0.032). Overall, 19.3% of the subjects reported an AE (18.1% in the DSG-OC group, 22.1% in the control group). CONCLUSION: Novial effectively reduces seborrhea after only four cycles of treatment and may be a suitable oral contraceptive for women wishing to improve their facial skin condition.

Acne Vulgaris↗

Effects of a phasic oral contraceptive containing desogestrel on facial seborrhea and acne.

BACKGROUND: The combined oral contraceptive containing ethinylestradiol and the selective progestogen, desogestrel, in a phasic regimen (DSG-OC, Tri-merci) has been shown to reduce facial oiliness. OBJECTIVE: This study was designed to evaluate further the effects of this OC on the skin of women with facial seborrhea and mild or moderate acne. DESIGN AND METHODS: This was an open, noncomparative, bicenter study in 60 healthy Russian women, aged 18-30 years, with facial seborrhea and mild or moderate facial acne, who wished to use oral contraception. All women received the OC containing desogestrel (50/100/150 microg) and ethinylestradiol (35/30/30 microg) for three phases of 7 days followed by a 7-day pill-free interval, for six cycles. Seborrhea was assessed using the Sebutape technique, in which strips of adhesive microporous polymeric film pressed onto facial sites are used to assess sebaceous activity. Acne was assessed by counting facial lesions. Subjective evaluations of skin and hair condition, patients' feelings to them and satisfaction with the OC were made using a visual analogue scale (VAS). Assessments were made at baseline, and after one, three and six treatment cycles. RESULTS: Sebutape assessments of seborrhea were significantly improved, on the right and left cheeks, after one treatment cycle, and on the forehead after three treatment cycles. These improvements increased steadily and were much larger at the end of Cycle 6. Acne grades were significantly improved after three and six treatment cycles. VAS scores in response to questions dealing with self-esteem and self-confidence were significantly improved after three cycles and in some cases after just one cycle. The women's views of their skin and hair (greasiness) were correspondingly significantly improved. Subjective assessments indicated that after one, three and six cycles, 69%, 93% and 98%, respectively, of women were satisfied or very satisfied with the DSG-OC. CONCLUSION: In women with facial seborrhea and mild or moderate acne, the use of DSG-OC appears to improve seborrhea after just one cycle and acne grades after three cycles. These improvements are accompanied by increases in self-esteem and confidence.

Acne Vulgaris↗

Comparison of the lipoprotein, carbohydrate, and hemostatic effects of phasic oral contraceptives containing desogestrel or levonorgestrel.

Desogestrel (DSG) is a less-androgenic progestogen than levonorgestrel (LNG). This difference in androgenicity may be responsible for observed differences in metabolic effects between oral contraceptive (OC) formulations containing almost equivalent estrogen doses but with either DSG or LNG as a progestogen. To test the hypothesis, a prospective 9-month randomized comparison of plasma lipids, glucose, insulin, hemostasis, and sex hormone binding globulin (SHBG) was conducted in 66 healthy women using phasic formulations of OCs containing either DSG (DSG-OC) or LNG (LNG-OC). The study results showed that SHBG increased 3-fold with DSG-OC and 2-fold with LNG-OC. DSG-OC increased HDL-C, HDL(2)-C and HDL(3)-C; LDL-C decreased transiently. LNG-OC decreased HDL(2)-C and increased HDL(3)-C; HDL-C was unchanged and LDL-C decreased transiently. Both formulations increased VLDL-C and triglycerides, more with DSG-OC, but apolipoprotein B levels increased equally. Apo A-I and A-II increased more with DSG-OC than with LNG-OC. Neither formulation altered Lp(a) or fasting glucose and insulin levels. Postprandially, both formulations decreased glucose and increased insulin responses, but to an equivalent degree. Both OCs slightly enhanced procoagulant and profibrinolytic parameters to the same extent except for internally compensating decreases in Factor V and protein S with DSG-OC. In summary, at almost equivalent estrogen doses, a phasic OC containing DSG compared with LNG has a less androgenic effect on lipoproteins and SHBG, similar effects on hemostatic parameters with lower protein S and factor V activity and equivalent effects on carbohydrate metabolism. The lipoprotein, SHBG, and protein S and factor V differences are likely due to the lesser androgenicity of DSG allowing for a greater expression of the dose of estrogen.

Adult↗

The effects of two phasic oral contraceptives on hemostasis and platelet function.

OBJECTIVE: To compare the effects on hemostatic parameters of a combiphasic oral contraceptive containing desogestrel and ethinyl estradiol (DSG/EE) and a triphasic oral contraceptive containing levonorgestrel and ethinyl estradiol (LNG/EE). METHODS: In an open-label, randomized, group-comparative study in 10 healthy volunteers per treatment group, the effects on parameters of coagulation, anticoagulation, fibrinolysis, antifibrinolysis and platelet function were determined at baseline, after three treatment cycles, and after a post-treatment cycle. Changes from baseline were analyzed using a paired t-test, whereas between-group differences were analyzed by means of an analysis of co-variance. RESULTS: Both OC preparations induced modest changes of some coagulation, anticoagulation, fibrinolysis and antifibrinolysis parameters, although all mean values remained within the normal range. No significant effects were observed with either OC with respect to platelet function. Statistically significant differences between the two preparations could occasionally e observed: the concentrations of antithrombin II (AT-III) and Factor VII were higher with the DSG/EE preparation than with LNG/EE preparation at the end of treatment and AT-III activity, AT-III concentration, Factor X concentration, and plasminogen activity were higher with DSG/EE than with LNG/EE in the post-treatment cycle. CONCLUSIONS: Combiphasic DSG/EE and triphasic LNG/EE, both OCs with a comparable amount of EE per cycle, had no clinically significant effect on the overall hemostatic balance.

Blood Coagulation↗

Observations with a tri-phasic oral contraceptive (Tri-Regol) in everyday clinical practice.

The theoretical general principles of triphasic oral contraception are discussed in the introduction. This method, which is the closest to a physiological dosage, seems to be the most advantageous today. International data and the advantages and wide indication field of such "step-up" tablets are also discussed. The observations with the Hungarian Tri-Regol tablet are described in detail. In the course of controlling 355 cycles of 79 women pregnancy was not observed, the tablets were well tolerated by the women-except for some milder side-effects. The use of Tri-Regol needed not be discontinued due to, any unwanted effect or complication. The rate of intermenstrual bleeding was very low, and the triphasic therapy proved to be beneficial in case of manifesting cycle disorders or if the change of the contraceptive tablet became necessary because of intolerance. According to the opinion of the authors the oral contraceptive Tri-Regol is today's drug of choice due to its reliable ovulation inhibitory action, low hormone content, and favourable tolerability.

Adolescent↗

Phasic approach to oral contraceptives.

Oral contraceptives were initially very high in estrogen and progestogen and had a uniform dosage schedule throughout the entire cycle. These early oral contraceptives were associated with high rates of side effects and complications. As a result, the hormone levels have been gradually reduced to attain the minimal amount necessary for contraception while most of the undesired side effects and complications have been eliminated. Recently, a new approach has been added. This mechanism consists of altering the dose of estrogen or progestogen or both during the month and is referred to as the phasic approach. The newest phasic pills now use a triphasic approach. Three basic formulations of the triphasic pill have been developed. In two of the three formulations, the progestogen level is altered, whereas the estrogen level remains stable; in the third formulation, both estrogen and progestogen are changed. Multiple clinical studies of the triphasics, such as ethinyl estradiol and levonorgestrel, prove that there is a significant reduction in the incidence of side effects and complications related to oral contraception.

Contraceptives, Oral, Combined↗

[Effect of oral contraceptives on plasma insulin and blood glucose levels after long term use (author's transl)].

Blood glucose and plasma insulin were measured during an intravenous glucose tolerance test (0.33 g/kg body weight) performed on 75 subjects. Various types of oral contraceptives were taken for an average period of 6.5 yrs. The cases were divided into several groups in order to examine the effect of combination-type drugs (group A; n= 40) and sequential-type drugs (group B; n = 23) separately. A third group had used both types of drugs (group C; n = 13). Fifteen women who have never taken hormone drugs served as control group. It was found that plasma insulin levels, blood glucose and k-values were not significantly elevated in the drug treated groups. The duration of treatment does not seem to have an effect on glucose tolerance and insulin secretion. In this study the patient's age is the most important associated data, and not overweight, family history of diabetes or past obstetric history. No statistical change in insulin levels, reaction areas of glucose and insulin after IVGTT was seen in any drug treated group.

Adult↗

[Insulin and proinsulin secretion under contraceptive steroid administration (author's transl)].

An ivestigation has been performed in 49 women about the influence exerted on the glucose-tolerance, insulin and proinsulin secretion by hormonal contraceptives of different types and compositions. A disturbed dynamics of the insulin secretion with elevated values in the OGTT at two and three hours has been proven at a nearly equal degree using combined preparations (Anacyclin, Eugynon, Neogynon, Mikrogynon) or sequential preparations (Kombiquens, Ovanon). Though there has been interference with the glucose tolerance, the serum proinsulin in the OGTT showed increased levels too. When a combined preparation was applied, the proinsulin values were significantyl higher compared to a sequential type contraceptive. The observed disturbance of the insulin and proinsulin secretion is explained by a decreased sensitivity to insulin in the peripheral fat tissue. The actual dose of the estrogen-gestagen components has no influence on the described changes. Elevated insulin levels are demonstrable already during the first treatment cycle. The degree of the disturbance is independent of the duration of the medicamentous application during the first 6 contraceptive months. After withdrawal of the respective contraceptive steroid the insulin secretion showed nearly normal dynamics during the subseqeunt menstrual cycle.

Blood Glucose↗

Role of estrogens and progesterone in the etiology and prevention of endometrial cancer: review.

Our present knowledge of the role of sex steroids in the development as well as the prevention of endometrial cancer is reviewed. Factors which increase the exposure of the uterus to unopposed estrogens, either exogenous or endogenous, are associated with increased risk of endometrial adenocarcinoma. However, there is increasing evidence that progestogens can reverse endometrial hyperplasia and protect against the development of endometrial cancer. The mechanisms to explain the antiestrogenic effects of progestogens include changes in enzyme activity and steroid receptors in endometrial tissue. Postmenopausal women treated with combined estrogen and progestogen have the lowest incidence of endometrial carcinoma. Oral contraceptives containing both estrogen and progestogen in each tablet are protective against adenocarcinoma of the endometrium, while the sequential oral contraceptive pills afforded less protection. The risks and benefits of these hormone therapies are discussed in relation to the etiology and prevention of endometrial cancer.

Animals↗