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At least 19 recordsLinked to original sources
PubMed2001

Biphasic versus monophasic oral contraceptives for contraception.

OBJECTIVES: To compare biphasic oral contraceptives with monophasic oral contraceptives in terms of efficacy, cycle control, and discontinuation due to side effects. Our a priori hypotheses were: (a) biphasic oral contraceptives are less effective in preventing pregnancy than are monophasic oral contraceptives, and (b) biphasic oral contraceptives cause more side effects, give poorer cycle control, and have lower continuation rates. SEARCH STRATEGY: We searched computerized databases MEDLINE, EMBASE, Popline and the Cochrane Controlled Trial Register. Additionally we searched the reference lists of all potentially relevant articles and book chapters. We also contacted the authors of relevant studies and pharmaceutical companies in Europe and the U.S. SELECTION CRITERIA: We included randomized controlled trials comparing any biphasic oral contraceptive with any monophasic oral contraceptive when used to prevent pregnancy. DATA COLLECTION AND ANALYSIS: We examined the studies found during the various literature searches for possible inclusion and assessed their methodological quality using the Cochrane guidelines. We contacted the authors of all included studies and of possibly randomized studies for supplemental information about the study methods and outcomes. We entered the data in RevMan 3.1, imported the data into RevMan 4.1, and calculated Peto odds ratios for the incidence of intermenstrual bleeding, absence of withdrawal bleeding, and study discontinuation due to intermenstrual bleeding. MAIN RESULTS: Only one trial of limited quality compared a biphasic and monophasic preparation. Percival-Smith et al. (1990) examined 533 user cycles of a biphasic pill (norethindrone 500 mcg/ethinyl estradiol 35 mcg for ten days, followed by norethindrone 1000 mcg/ethinyl estradiol 35 mcg for eleven days; Ortho 10/11) and 481 user cycles of a monophasic contraceptive pill (norethindrone acetate 1500 mcg/ethinyl estradiol 30 mcg daily; Loestrin). The study found no significant differences in intermenstrual bleeding, amenorrhea and study discontinuation due to intermenstrual bleeding between the biphasic and monophasic oral contraceptive pills. REVIEWER'S CONCLUSIONS: Conclusions are limited by the identification of only one trial, the methodological shortcomings of that trial, and the absence of data on accidental pregnancies. However, the trial found no important differences in bleeding patterns between the biphasic and monophasic preparations studied. Since no clear rationale exists for biphasic pills and since extensive evidence is available for monophasic pills, the latter are preferred.

Contraception↗
PubMed1981

Effects of estrogens and progestins on the biochemistry and morphology of the postmenopausal endometrium.

To study the effects of exogenous estrogens on the postmenopausal endometrium, and to determine the time course and minimum dosage of added progestins necessary to oppose estrogen stimulation, we obtained endometrial specimens from symptomatic postmenopausal women being treated with various preparations of estrogens and progestins. Morphologic changes were assessed with light and electron microscopy, and biochemical effects through measurement of DNA synthesis, estradiol and progesterone receptors, and isocitric and estradiol dehydrogenase activity. For comparison, identical studies were carried out on specimens from premenopausal women in the proliferative and secretory phases of their cycle. All the estrogens exerted stimulatory effects in the postmenopausal specimens that were comparable to those observed in the premenopausal proliferative-phase specimens. Estropipate, subcutaneous estradiol, and conjugated estrogens had some hyperphysiologic effects. Maximal progestational effects occurred in the postmenopausal specimens only after norethindrone was administered for six days, and a constant level of activity equal to that in premenopausal secretory-phase specimens was then observed until the 10th day of exposure. Similar maximal effects occurred after six days of treatment with D/L-norgestrel (150 and 5 mg daily [10 mg daily produced less complete changes]). We conclude that many estrogen preparations subject the endometrium to a potent stimulus. Norethindrone and norgestrel are protective because they counteract the proliferative effects of estrogens, but the currently recommended daily dosages of these progestins can be greatly reduced without loss of response.

DNA↗
PubMed1997

Simultaneous determination of ethinylestradiol and levonorgestrel in oral contraceptives by derivative spectrophotometry.

A method for determining ethinylestradiol (ETE) and levonorgestrel (LEV) in mixtures by first-derivative spectrophotometry is described. The procedure does not require any separation step. Measurements are made at the zero-crossing wavelengths and the calibration graphs are linear up to 26 and 33 micrograms ml-1 of ETE and LEV, respectively. The method was applied to the determination of both compounds in five different Spanish commercial low-dose oral contraceptives. Similar results were obtained by an HPLC method.

Chromatography, High Pressure Liquid↗
PubMed2001

Effect of a combined oral contraceptive containing 3 mg of drospirenone and 30 microg of ethinyl estradiol on the human endometrium.

OBJECTIVE: To provide an in-depth assessment of the effects of the combined oral contraceptive containing 30 microg of ethinyl estradiol and 3 mg of drospirenone (Yasmin, Schering AG, Berlin) on the endometrium by means of endometrial morphometry in comparison to an untreated cycle. DESIGN: The open, multicenter study consisted of one untreated precycle and 13 treatment cycles. SETTING: Four gynecologic clinics in Belgium, The Netherlands, and Switzerland were involved. PATIENT(S): Forty women with a history of regular menstrual cycles. INTERVENTION(S): Before the commencement of the trial, 3 months without any hormonal intake was obligatory. The first endometrial sample was done in the untreated precycle, adjusted to the day of LH peak plus 5 to 6 days. During the medication phase, endometrial samples were taken at cycle 3, 6 and 13. MAIN OUTCOME MEASURE(S): Primary outcome measure of the study was the morphologic assessment of the endometrium with measures such as glandular diameter, glandular epithelial height, and number of vacuolated cells per 1,000 glandular cells. Furthermore, the endometrial thickness was measured by ultrasound. RESULT(S): After 13 cycles of medication use the endometrium had an atrophic appearance in 63% of the subjects. The size of the glands, the glandular epithelial height, and the number of glands per square millimeter were already significantly reduced after 3 months' use. Histological and ultrasonographical evaluation of the endometrium indicated a suppression of the proliferative activity of the endometrium. CONCLUSION(S): The combination of 30 microg of ethinyl estradiol with 3 mg of drospirenone induces changes of the endometrium that are comparable with other combined oral contraceptives and exhibits a marked antiproliferative effect on the endometrium. The medication was proven to be an effective oral contraceptive and revealed good cycle control characteristics.

Adult↗
PubMed1998

Effects of oral contraceptives containing different progestogens on sodium-lithium countertransport in normal females.

In view of the lack of unanimity on the effect of long-term intake of combined oral contraceptives (OC) on external sodium-dependent lithium efflux, otherwise known as sodium-lithium countertransport (SLC), we undertook a double-blind study to investigate the possible interaction between SLC and OC in healthy women with regular menstrual cycles. In a group of 17 volunteers, aged 27.0 +/- 1.1 years (mean +/- s.e.m.) and weighing 61.4 +/- 2.0 kg, ingestion of 30 microg ethinyloestradiol + 150 microg desogestrel for 3 months caused an increase in SLC activity from a baseline value of 0.254 +/- 0.017 mmol/lcell x h to 0.274 +/- 0.017 mmol/lcell x h (P = 0.05). The activity of the transport system after 6 months treatment remained higher than at baseline (0.280 +/- 0.016 mmol/lcell x h, P < 0.025) but was comparable to that at 3 months. Blood pressure and weight remained unaltered during the study period. In a comparable group of 16 volunteers of age 26.1 +/- 1.3 years and weight 63.5 +/- 2.1 kg, control SLC activity (0.218 +/- 0.012 mmol/lcell x h) was comparable to that after 3 months (0.215 +/- 0.011 mmol/lcell x h) and 6 months (0.216 +/- 0.011 mmol/lcell x h) intake of 35 microg ethinyloestradiol + 2 mg cyproterone acetate. Body weight and blood pressure remained similarly unchanged. These results not only confirm that long-term intake of OC may cause increased SLC activity, but also suggest that the type of the progesterone in the medication used could be an important determinant of such interaction.

Adolescent↗
PubMed2002

Determination of steroid hormones in oral contraceptives by high-performance liquid chromatography.

The aim of this research was to standardize a high-performance liquid chromatographic method for quantitative determination of steroid hormones, like ethinylestradiol (ETE), levonorgestrel (LEVO), and gestodene (GEST), in commercially available oral contraceptives (OCs). The combination ETE-LEVO was analyzed using a LiChrospher 100 RP-8 column (5 microns, 125 x 4 mm) in LiChroCART, with a mobile phase constituted of acetonitrile: water (60:40 v/v). Using the same column, ETE-GEST was analyzed with a mobile phase constituted of acetonitrile:water (50:50 v/v) at pH 7.5 adjusted with 0.02 M ammonium hydroxide. For both methods, a flow rate of 0.8 mL/min was utilized and detection was carried out at 215 nm. All analyses were performed at room temperature (24 +/- 2 degrees C). Calibration curves for ETE-LEVO were obtained using solutions with concentration ranges from 2.40 to 60.0 micrograms/mL (ETE), and from 12.0 to 300.0 micrograms/mL (LEVO). Calibration curves for ETE-GEST were obtained using solutions with concentration ranges from 2.40 to 60.0 micrograms/mL (ETE), and from 9.0 to 160.0 micrograms/mL (GEST). Correlation coefficients obtained were from 0.9999 to 0.9990. Coefficients of variation for samples containing ETE-LEVO were 0.47% and 0.38%, respectively. For samples with ETE-GEST they were 0.39% and 0.44%, respectively. The average recovery for samples with ETE-LEVO was 103.46% and 100.78%, respectively. For samples containing ETE-GEST it was 100.89% and 101.03%, respectively.

Calibration↗
PubMed1997

Clinical experience of a combined oral contraceptive with very low dose ethinyl estradiol.

BACKGROUND: The risk of thromboembolic events related to the ethinyl estradiol (EE) dose in oral contraceptive (OC) pills has led to a further dose reduction. METHODS: An OC pill with 150 micrograms desogestrel combined with only 20 micrograms EE was compared with a pill containing the same dose of desogestrel but 30 micrograms of EE in a Scandinavian multicentre study with follow-up visits after 3, 6 and 12 months. RESULTS: In almost 5,000 cycles with each pill the numbers of pregnancies due to method failure with the lower and higher EE dose pills were 0 and 2, respectively. Irregular bleedings were slightly more common with the lower EE dose, but tended to decrease over the year of study. Other side effects were uncommon. Regarding metabolic effects, both pills tended to raise the plasma HDL level and the lower EE dose pill also reduced LDL. Free testosterone was reduced by two-thirds with both pills, showing beneficial effects on acne. CONCLUSIONS: It is concluded that both these pills are reliable and safe, but that many women would accept a slightly greater risk of irregular bleeding with the 20 micrograms EE dose pill in exchange for a reduction in potential risk related to the estrogenic component of OC pills.

Adolescent↗
PubMed1996

The effects of a low-dose gestodene-containing oral contraceptive on endometrial histology in healthy women.

OBJECTIVE: In women who use oral contraceptives with low estrogen doses, a quiescent endometrium is frequently produced. Further reduction of the estrogen dose would not be expected to alter this effect. In this open-label study, the effects on the endometrium of a monophasic oral contraceptive containing 75 micrograms gestodene and 20 micrograms ethinylestradiol were assessed. METHOD: Biopsies were performed on 25 women on therapy. The biopsies were performed during the late luteal phase (last 7 days) in the pretreatment cycle and during days 15-21 in cycle 6 for 13 subjects (Group A) and during days 15-21 in cycle 3 and during the late luteal phase (last 7 days) in the post-treatment cycle for 12 subjects (Group B). RESULTS: All subjects completed six cycles of treatment. Nine of 13 subjects pretreatment and nine of 12 subjects at cycle 3 were characterized by the pathologist as having a secretory endometrium. Four of 13 subjects at cycle 6 and ten of 11 subjects post-treatment also demonstrated a secretory endometrium. Pre-decidual changes were seen in one, two, two and zero subjects at pretreatment, after three cycles, six cycles, and post-treatment, respectively. Six subjects had an atrophic endometrium at cycle 6. CONCLUSIONS: With monophasic gestodene/ethinylestradiol 75 micrograms/20 micrograms, a secretory or inactive endometrium was present in most subjects. Thus, the effects on the endometrium of this oral contraceptive containing a reduced estrogen dose are consistent with those produced by other low-estrogen-dose combination oral contraceptives.

Adult↗
PubMed1999

A comparative study of the hemostatic effects of two monophasic oral contraceptives containing 30 mu(g) ethinylestradiol and either 2 mg chlormadinone acetate or 150 mu(g) desogestrel.

OBJECTIVES: To determine the effect of two low-dose monophasic oral contraceptives containing either 2 mg chlormadinone acetate or 150 microg desogestrel on blood clotting and fibrinolysis. METHODS: In vivo markers of intravascular coagulatory and fibrinolytic activity were measured in 45 volunteers randomly assigned to a 6-month treatment with one of the two study preparations. RESULTS: During oral contraceptive use, the procoagulatory activity increased (increased prothrombin fragment 1+2), the anticoagulatory capacity changed (increased protein C activity, decreased activated protein C sensitivity, decreased protein S activity and decreased antithrombin III activity) and the fibrinolytic system was activated (increased concentrations of plasmin-antiplasmin complexes and D-dimer as well as total fibrin degradation products). There were no relevant differences between the two medication groups. CONCLUSION: Our results demonstrate that both oral contraceptive preparations have comparable effects on the hemostatic system. There was a shift towards a new equilibrium of hemostatic activities, both coagulatory and fibrinolytic, at a higher turnover rate. Changes did not exceed the range of normal variation and were comparable to the published effects of other low-dose oral contraceptives. There was no evidence ofa differential risk of deep vein thrombosis between the two preparations.

Adolescent↗
PubMed1995

[The desogestrel-ethinyl estradiol combination and overweight: current data].

The effects of various progestins combined with ethynil estradiol, on body weight, are reviewed. A new group of obese patients being treated for weight excess, using desogestrel-ethynil estradiol (150 mg plus 30 mcg) as a contraceptive, was studied in conditions similar to those published in 1992. Very satisfactory results were obtained, as these patients lost body weight until reached ideal weight, without interference from the contraceptive compound used.

Adolescent↗
PubMed1977

The effects of ergosterol on the response of female chicks to oral oestrogens and progestogens.

The chick-oviduct assay was used to investigate the effects of dietary ergosterol on the response to oral progestogens and oestrogens. 2. Progestogens alone had no effect on the oviduct but the hypertrophy due to oestrogen was greatly enhanced by simultaneous treatment with progestogen at all dose levels tested. 3. Ergosterol had no effect on any of the responses of the oviduct studied.

Animals↗