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At least 19 recordsLinked to original sources
PubMed1992

Oral contraceptive type and functional ovarian cysts.

OBJECTIVE: We tested the hypothesis that multiphasic, low-dose monophasic, and high-dose monophasic oral contraceptives share a common protective effect against functional ovarian cysts. STUDY DESIGN: We conducted a cohort study using the automatic files of Maine Medicaid to assemble a population of 7462 women between the ages of 15 and 44 who were prescribed an oral contraceptive between Jan. 1, 1987, and Dec. 31, 1988. We included as cases 32 women with a principal diagnosis of a functional ovarian cyst confirmed by medical records as being greater than 20 mm in diameter. RESULTS: At comparison with the absence of an oral contraceptive prescription, we observed decreasing rates of functional ovarian cysts among women prescribed multiphasic pills (rate ratio 0.91, 95% confidence interval 0.3000 to 2.31), low-dose monophasic pills with less than or equal to 35 micrograms estrogen (rate ratio 0.52, 95% confidence interval 0.17 to 1.33), and high-dose monophasic pills with greater than 35 micrograms estrogen (rate ratio 0.24, 95% confidence interval 0.01 to 1.34). CONCLUSIONS: The protective effect of oral contraceptives against functional ovarian cysts reported previously for high-dose monophasic pills may be attenuated with newer pills of lower hormonal potency.

Adolescent↗
PubMed1989

Comparative metabolic effects of three types of combined oral contraceptive pills in Chinese women.

The results of a prospective longitudinal controlled study comparing some metabolic effects of a low-dose levonorgestrel-ethinyl oestradiol combined oral contraceptive (Microgynon 30), a desogestrel-ethinyl oestradiol-containing pill (Marvelon) and a levonorgestrel-ethinyl oestradiol triphasic preparation (Triquilar) after one year of treatment in ethnic Chinese women are presented. Serum cholesterol levels are similar for the three pills at 6 and 12 months of treatment. Marvelon and Triquilar users showed rises in triglyceride levels while Microgynon 30 users had no change after one year of treatment. Lipoprotein fractions showed favourable changes in Triquilar and Marvelon users with significant rise in HDL fractions at 6 and 12 months; Microgynon 30 users had equivocal changes in HDL fractions. Carbohydrate metabolism as reflected by glucose tolerance showed deterioration with all 3 pills, being least with Microgynon 30 and greatest with Marvelon at 12 months.

Adolescent↗
PubMed1992

Six-month carbohydrate metabolism studies in women using oral contraceptives containing gestodene and ethinyl estradiol.

Twenty-five women had their carbohydrate metabolism prospectively evaluated during the six months that they used a gestodene and ethinyl estradiol monophasic oral contraceptive. Serum glucose and insulin levels were measured during a 75-gram three-hour oral glucose tolerance test. At the six-month test, the three-hour glucose and the fasting and three-hour insulin values were significantly elevated. The literature on carbohydrate metabolism during gestodene oral contraceptive use is also reviewed.

Adult↗
PubMed1992

A randomized, double-blind, placebo-controlled comparison of the impact of low-dose and triphasic oral contraceptives on follicular development.

OBJECTIVE: This investigation tests the hypothesis that triphasic oral contraceptives are associated with the development of large, persistent ovarian cysts. STUDY DESIGN: Weekly vaginal ultrasonography was used in a randomized, double-blind, placebo-controlled, parallel-group, single-center study that compared the incidence, risk, size, and time to resolution of ovarian follicles in healthy women who took Estrostep or Loestrin oral contraceptives (manufactured by Parke-Davis) or a placebo during three consecutive menstrual cycles. RESULTS: Sixty-three percent of placebo-treated subjects developed follicles greater than 18 mm, compared with 39% and 23% in the Estrostep and Loestrin groups. The risks for each group of developing a large follicle during a single cycle were not different. No dominant follicle persisted for greater than 2 weeks for any subject. CONCLUSION: These results demonstrate that follicular development continues during treatment with oral contraceptives. In addition, the findings fail to support the hypothesis that triphasic oral contraceptives result in persistent ovarian cysts.

Adult↗
PubMed1992

Changes in coagulation and anticoagulation in women taking low-dose triphasic oral contraceptives: a controlled comparative 12-month clinical trial.

OBJECTIVE: The effects of two triphasic oral contraceptives on coagulation and anticoagulation factors were compared in a 12-month open-label study. STUDY DESIGN: Fifty-two women (mean age 26 years) were enrolled in and completed the study; 20 had been randomly assigned to receive levonorgestrel plus ethinyl estradiol, 24 had been randomly assigned to receive norethindrone plus ethinyl estradiol, and eight surgically sterile women acted as untreated controls. Coagulation and anticoagulation factors were measured at baseline and during the sixth and twelfth months. RESULTS: Both oral contraceptives produced significant decreases from baseline in prothrombin time and partial thromboplastin time; there were also significant changes in laboratory control times. Factor XII was significantly increased in both oral contraceptive groups after 6 and 12 months. Fibrinogen antigen was significantly increased for norethindrone plus ethinyl estradiol after 6 and 12 months and for levonorgestrel plus ethinyl estradiol after 12 months. Platelet counts were unchanged. There was a significant increase in antithrombin III activity with norethindrone plus ethinyl estradiol at 12 months. Antithrombin III antigen was unchanged with the oral contraceptives; however, significant increases existed for alpha 1-antitrypsin antigen and plasminogen antigen and activity after 6 and 12 months and for alpha 2-macroglobulin antigen after 12 months for both oral contraceptives. alpha 2-Antiplasmin antigen was significantly increased for norethindrone plus ethinyl estradiol at the 12-month evaluation. There were no significant differences between the oral contraceptives for any coagulation or anticoagulation factor, and mean values generally remained within reference ranges. CONCLUSIONS: Levonorgestrel plus ethinyl estradiol and norethindrone plus ethinyl estradiol had equivalent, minimal effects on hemostasis, and changes in coagulation factors appeared to be balanced by changes in anticoagulation factors.

Adult↗
PubMed1989

Evaluation of the clinical performance of three triphasic oral contraceptives: a multicenter, randomized comparative trial.

Three hundred thirteen women participated in an open, multicenter comparison of the incidence of intermenstrual bleeding (breakthrough bleeding and or spotting) associated with the use of three triphasic oral contraceptives. Triphasil (n = 107), containing levonorgestrel and ethinyl estradiol, and Ortho-Novum 7/7/7 (n = 97) and Tri-Norinyl (n = 109), both of which contain norethindrone and ethinyl estradiol, were administered over four cycles for a total of 1141 cycles. The total incidence of intermenstrual bleeding was significantly lower with Triphasil (17.2%) than with Ortho-Novum 7/7/7 (39.5%) or Tri-Norinyl (49.0%). The pattern remained the same when findings were analyzed cycle by cycle and for breakthrough bleeding and spotting separately. The incidence of other side effects was comparable for all regimens. Results of this study demonstrate superior cycle control with Triphasil compared with Ortho-Novum 7/7/7 and Tri-Norinyl during the first four cycles of use.

Adolescent↗
PubMed1989

A comparative analysis of three different dose combinations of oral contraceptives.

Three different low-dose formulations of oral contraceptives were compared to determine the most suitable preparation for Filipino women as reflected in the first year continuation rates, incidence of side effects and failure rates. A total of 1,800 subjects were enrolled in the study from 18 health centers in six provinces in two regions of the Philippines, covering a total of 18,282 women-months of use. Sociodemographic characteristics were comparable. The monophasic levonorgestrel group showed the best performance followed by the triphasic preparation. The norethindrone group consistently showed higher drop-out rates, which may be due to the relatively higher incidence of side effects. For all three preparations, bleeding irregularities were low. There were no major side effects and no pregnancy was reported in one year of use. Noted was a distinct regional and provincial difference in recruitment and follow-up performance, possibly due to clinic, client or program factors.

Adult↗
PubMed1992

Influence of estrogens and progesterone on the venous system of the lower limbs in women.

Treatments with estrogens and progestogens are suspected of causing vascular complications either directly or by metabolic consequences. Although many studies have demonstrated an increased incidence of arterial and deep venous thrombosis, since 1970 the dose of estrogens and progesterones have been lowered with a proportional lowering of side effects. After classification of estrogens and progestogens, we studied their peripheral vascular effects. In our study, we demonstrated that the effects of estroprogestogen treatment on the superficial venous system depend on the dose of estrogen and progestogen.

Adult↗
PubMed1992

Comparative contraceptive efficacy and mechanism of action of the norgestimate-containing triphasic oral contraceptive.

Norgestimate (NGM), a derivative of 19-nortestosterone with very specific affinity for the progesterone receptor, has been used in combination with ethinyl estradiol (EE) at low doses in both monophasic and triphasic oral contraceptives (OCs). An open-label comparative clinical trial was conducted with 4,234 healthy women using comparative clinical trial was conducted with 4,234 healthy women using triphasic levonorgestrel (LUG)/EE and NGM/EE through a total of 22,312 menstrual cycles. Contraceptive (LUG)/EE and NGM/EE through a total of 22,312 menstrual cycles. Contraceptive efficacy was excellent with both preparations, with no statistically significant between-regimen differences in pregnancy rates. The theoretical Pearl index was the NGM/EE triphasic, and 0.34 for the LNG/EE triphasic. Adverse experiences in groups were typical of those that may occur among women taking low-dose OC agents. was similar with the two preparations: 8.6% for the NGM/EE triphasic and 6.8% for the LNG/EE triphasic. In a separate mechanism of action study, specific endocrine parameters were investigated in 20 subjects using the NGM/EE triphasic for 4 cycles. Ovulation suppression was demonstrated in statistically significant decreases from pretreatment values in serum levels of luteinizing hormone, follicle-stimulating hormone, progesterone, and estradiol. Significant on-treatment increases in serum levels of sex hormone binding globulin evidenced minimal androgenicity. All hormonal values returned to or toward normal in the post-treatment cycle. The study results support those obtained in large noncomparative studies of the NGM/EE triphasic. This phased-dose combination suppresses ovulation and is a very effective, minimally androgenic contraceptive agent with a good safety profile.

Adolescent↗
PubMed1992

Selectivity and minimal androgenicity of norgestimate in monophasic and triphasic oral contraceptives.

The contraceptive progestin norgestimate (NGM) has a high affinity for uterine progestin receptors and a lack of affinity for androgen receptors similar to that of natural progesterone. NGM's selectivity results in excellent efficacy, cycle control, and minimal androgenicity when it is combined with ethinyl estradiol (EE). Clinical studies of a monophasic regimen of NGM/EE indicate a positive impact on lipid metabolism, revealing an increase in serum levels of high-density lipoprotein cholesterol with a concomitant and significant decrease in the low-density lipoprotein/high-density lipoprotein cholesterol ratio. Little impact on carbohydrate metabolism was noted. Serum levels of sex hormone binding globulin, an indicator of androgen-estrogen balance, also increased significantly with NGM/EE in accordance with its low androgenic activity. A significant between-regimen difference in SHBG was seen in a comparison study of NGM/EE and LNG/EE triphasic formulations (a mean rise of 68.6% with NGM/EE vs a decrease of 6.1% with LNG/EE). NGM's lack of estrogenicity was evidenced by unchanged prolactin levels and absence of effect on the coagulation system. In a large study of the monophasic formulation in 59,701 women, some improvement in acne was reported as well as minimal weight gain. An overview of clinical data is provided from United States and European trials as well as some preclinical data relevant to NGM's selectivity.

Acne Vulgaris↗
PubMed1992

Cycle control with triphasic norgestimate and ethinyl estradiol, a new oral contraceptive agent.

Effective cycle control was demonstrated based on two multicenter, 2-year studies of the triphasic oral contraceptive (OC) agent containing the new progestin norgestimate. The estrogen in this OC is ethinyl estradiol. These open-label Phase III studies were conducted in the United States by 33 investigators at 33 sites who treated a total of 1,783 subjects, healthy women 17 to 38 years of age with menstrual cycle characteristics considered to be within the normal range. The norgestimate/ethinyl estradiol preparation was taken for up to 24 cycles. Follow-up information was collected 3 to 4 months post-treatment. Bleeding pattern analyses were based on 27,970 valid cycles. Normal cyclic bleeding patterns were experienced by most of the women during the study; only minimal and statistically and clinically insignificant variations in menstrual flow, dysmenorrhea, and premenstrual tension occurred. There was a low incidence of failed withdrawal bleeding in single cycles (less than 1.0% after cycle 6). There were no cases of amenorrhea, defined as two consecutive cycles of missed withdrawal flow. The incidence of breakthrough bleeding or spotting was highest during the initial treatment cycles and diminished with continued use of the formulation. The mean incidence of breakthrough bleeding was 2.36% in cycles 13 to 24. Apart from somewhat higher initial percentages among women new to oral contraception, the pattern of midcycle bleeding or spotting was similar to that of all women studied. Effective long-term cycle control was demonstrated in women who used this OC agent.

Adolescent↗
PubMed1992

Clinical evaluation of a new triphasic oral contraceptive: norgestimate and ethinyl estradiol.

The safety and efficacy of the triphasic oral contraceptive agent containing norgestimate and ethinyl estradiol were evaluated in a 12-month study of 661 women. Excellent contraceptive efficacy was achieved, with two pregnancies ascribed to product failure in a total of 6,511 treatment cycles. The life-table predicted pregnancy rate was 0.57 per 100 woman-years of use. The overall and theoretical Pearl indexes were 0.55 and 0.37, respectively. Good cycle control was maintained in patterns similar to those noted in previous studies. The incidence of dysmenorrhea and premenstrual syndrome was sharply reduced. Side effects reported were typical of those associated with use of low-dose oral contraceptive agents. Acceptability was high compared with agents used previously by the subjects. Total cholesterol did not change but high-density lipoprotein cholesterol was significantly elevated at 3 and 12 months. There were no clinically significant changes in the parameters of hematology or blood chemistry tested.

Adolescent↗
PubMed1992

A comparison study of lipid and androgen metabolism with triphasic oral contraceptive formulations containing norgestimate or levonorgestrel.

The effects of norgestimate triphasic (Ortho Tri-Cyclen, Tri-Ciles) and levonorgestrel triphasic (Triphasi) formulations on lipid and androgen metabolism were assessed in a study of 66 healthy women treated through six menstrual cycles. Levels of the following were measured: cholesterol and its subfractions, triglycerides, carrier lipoproteins, estradiol, testosterone, and sex hormone binding globulin (SHBG). Comparison of baseline values with values after 3 and 6 months of treatment indicated that both regimens influenced lipid and androgen metabolism. There was a statistically significant between-regimen difference in levels of high-density lipoprotein, which were favorably increased with norgestimate triphasic but reduced with levonorgestrel triphasic. Related data on SHBG showed that plasma levels of this marker of estrogen/androgen balance were increased significantly more in the norgestimate triphasic group, providing additional evidence of low androgenicity. Both regimens inhibited follicular growth to the same extent, as evidenced by low mean levels of estradiol in all on-therapy cycles; and both decreased free testosterone. Side effects in both groups were minor and characteristic of those observed with low-dose oral contraceptive agents. The results of the study support the reported safety and positive effects of norgestimate on lipid and androgen metabolism, in comparison with a levonorgestrel-containing combined oral contraceptive.

Adolescent↗
PubMed1975

[Incidence of the Blastomyces and Trichomonad infections during the use of hormonal and intrauterine contraception].

The vaginal smear of 200 women treated with hormonal contraceptives (group A), of 45 women using an IUD (group B) and of 220 women representing an untreated control group (group C) was investigated on infection with vaginal yeasts and trichomonads. It was found, that infection with vaginal yeasts in women of group A was significantly higher (23,7%), than in women of group B (9,0%) and group C (9,5%). The occurance of trichomonads was also different between the groups. It was about 6,6% in group B and 6,8% in group C but only 2,1% in group A. From these results we concluded, that hormonal contraceptives on vaginal yeast infections act as a stimulating factor.

Blastomycosis↗
PubMedDate not supplied

[The effect of oral ovulation inhibiting (mono-, bi- and triphase) contraceptives and of Continuin and Postinor on proteo- and steroid hormones].

Endocrinological changes due to the effect of treatment with mono-, bi- and three-phase contraceptive pills taking continuously and occasionally are reviewed. It is established that oral contraceptives based on ovulation inhibition are safe. Less side effects are produced by Ovidon tablets. Continuin and Postinor pills are not safe, and they can produce irregular bleeding. Beside their numerous advances extrauterine pregnancy frequently happens (6.4%). A three-phase preparation is expected to have a reversible effect and lack of a consequent functional infertility. This is improved by hormone level measurements.

Adult↗
PubMed1991

Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial.

A phase IV trial evaluated the efficacy and safety of a monophasic oral contraceptive formulation, ethynodiol diacetate, 1 mg, plus ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) (Demulen 1/35). Nine hundred eighty-three community-based obstetrician-gynecologists treated a total of 7,759 patients with EDA 1 mg with EE 35 micrograms for one to eight months. Clinical evaluation forms on 6,382 patients were amenable to analysis for safety (including breakthrough bleeding, ovarian cyst formation and complexion changes); 5,412 patients were evaluable for efficacy (prevention of pregnancy), with a total of 21,440 cycles recorded. The study results were interpreted in terms of the impact on clinical management of oral contraceptive users and the methods, strengths and weaknesses of phase IV trials, particularly as they relate to confirmation of the results reported here.

Adolescent↗