Μg Levonorgestrel Research Articles

Endometrial adenocarcinoma following insertion of the levonorgestrel-releasing intrauterine system (mirena) in a 36-year-old woman

The levonorgestrel-releasing intrauterine system (LNG-IUS), commonly referred to as mirena, is an effective form of contraception, which is widely used as an intrauterine device. It has a 32-mm long-shaped plastic frame that holds a reservoir (on the vertical stem) of 52 mg of levonorgestrel mixed with polydimethylsiloxane to allow a steady release of 20 mug of levonorgestrel per day within the endometrial cavity through a rate-limiting surface membrane. Apart from contraceptive purpose, it is also now commonly used in the management of heavy menstrual blood loss. This study included a 36-year old woman who developed endometrial cancer following the insertion of the LNG-IUS. Her main presentation was irregular vaginal bleeding, which is a common finding in women using this form of contraception. Although we would advice caution in investigating such women, the LNG-IUS remains a relatively safe method of contraception.

Endometrial adenocarcinoma following insertion of the levonorgestrel-releasing intrauterine system (mirena) in a 36-year-old woman

The levonorgestrel-releasing intrauterine system (LNG-IUS), commonly referred to as mirena, is an effective form of contraception, which is widely used as an intrauterine device. It has a 32-mm long-shaped plastic frame that holds a reservoir (on the vertical stem) of 52 mg of levonorgestrel mixed with polydimethylsiloxane to allow a steady release of 20 μg of levonorgestrel per day within the endometrial cavity through a rate-limiting surface membrane. Apart from contraceptive purpose, it is also now commonly used in the management of heavy menstrual blood loss. This study included a 36-year old woman who developed endometrial cancer following the insertion of the LNG-IUS. Her main presentation was irregular vaginal bleeding, which is a common finding in women using this form of contraception. Although we would advice caution in investigating such women, the LNG-IUS remains a relatively safe method of contraception.

Bleeding patterns after use of levonorgestrel emergency contraceptive pills

Objective The objective of this study was to describe bleeding after use of an emergency contraceptive pill (ECP) regimen consisting of 1.5 mg of levonorgestrel in a single dose. Methods We asked 120 women who had been treated with the regimen to keep daily bleeding diaries for 9 weeks. We compared bleeding patterns observed after treatment with usual patterns reported by the participants and with patterns observed in a prior study on women who had not taken ECPs. Results Treatment in the first 3 weeks of the menstrual cycle significantly shortened that cycle as compared both with the usual cycle length and with the cycle duration in a comparison group. The magnitude of this effect was greater the earlier the pills were taken. In contrast, the duration of the first menstrual period after treatment increased significantly with cycle week of treatment and was longer in women who used the treatment than in those who did not. Intermenstrual bleeding occurred in only 5% of women in the first cycle after treatment. Conclusions The effect of the single-dose levonorgestrel ECP regimen on the timing and duration of the next menstrual period depends on when during the cycle the pills are taken. Intermenstrual bleeding following treatment is uncommon.

Safety and efficacy of an extended-regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol

Objective To assess the efficacy and safety of Seasonique™, a 91-day extended-regimen oral contraceptive (OC) utilizing continuous low-dose ethinyl estradiol (EE) during the typical hormone-free interval. Methods A multicenter, open-label, 1-year study of Seasonique™ [30 μg EE/150 μg levonorgestrel (LNG)] for 84 days followed by EE 10 μg for 7 days was conducted in sexually active, adult women of childbearing potential. All patients completed daily electronic diaries to monitor compliance and bleeding. Results Method failure rate was 0.78 (Pearl index) and 0.64% (life table analysis). Cycle control and safety of the regimen were similar to that reported for other OCs. Conclusion This study demonstrates that Seasonique™ is effective, safe and well tolerated for the prevention of pregnancy.

Effects of a subdermal levonorgestrel contraceptive implant (Norplant) on serum cholesterol, triglycerides, ALT and AST in Iranian women

Background To evaluate the effects of Norplant (36 mg of levonorgestrel, six capsules) on serum cholesterol, triglycerides, alanine transaminase (ALT) and aspartate transminase (AST), we enrolled 465 healthy women from Zahedan, Iran, into a longitudinal study. Materials and Methods Blood samples were collected after an overnight fast before implant insertion and after 3, 6, 9 and 12 months of use. Results Total cholesterol and triglyceride levels did not significantly change during Norplant use. Although there were statistically significant increases in ALT and AST levels during Norplant use, the values were within the reference range.

Comparison of vaginal and oral administration of emergency contraception

To compare the physiologic effects of vaginally and orally administered emergency contraception. Prospective, open-label, crossover study. University research center. Nine regularly menstruating volunteers. Five subjects received 1,000 microg of levonorgestrel with 200 microg of ethinyl E2 (twice the standard Yuzpe regimen dose) vaginally, and the standard Yuzpe regimen dose orally 1 week later. Four subjects received 1,500 microg of levonorgestrel (twice the standard Plan B regimen dose) vaginally and received the standard Plan B dose orally 1 week later. Serum samples were obtained at baseline and at frequent intervals after each dose. Serum gonadotropin, hepatic globulin, and androgen levels measured at baseline, at the time of peak levonorgestrel, and 24 hours later. Gonadotropin, hepatic globulin, and androgen levels were suppressed to a similar degree among the four regimens, with a return to baseline levels after 24 hours. We conclude that high doses of levonorgestrel found in emergency contraception regimens lead to a transient direct suppression of gonadotropin, hepatic globulin, and androgen levels. This effect is similar after vaginal and oral administration of emergency contraception. Therefore, the vaginal route of administration of emergency contraception regimens may be as efficacious as the oral route.

A 1-year randomized study to evaluate the effects of a dose reduction in oral contraceptives on lipids and carbohydrate metabolism: 20 μg ethinyl estradiol combined with 100 μg levonorgestrel

Objectives To evaluate the impact on lipid and carbohydrate variables of a combined one-third ethinyl estradiol (EE)/levonorgestrel (LNG) dose reduction in oral contraceptives. Methods In an open-label, randomized study, a dose-reduced oral contraceptive containing 20 μg EE and 100 μg LNG (20 EE/100 LNG) was compared with a reference preparation containing 30 μg EE and 150 μg LNG (30 EE/150 LNG). One-year data from 48 volunteers were obtained. Results We found a decrease of HDL2 cholesterol and increases of low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol and total triglycerides in both treatment groups from baseline to the 13th treatment cycle. Although for four of six variables, the changes in the 20 EE group were lower compared with the 30 EE group, none of the differences between the two treatments were statistically significant. The median values for the fasting levels of insulin, C-peptide and free fatty acids slightly increased or remained unchanged while the fasting glucose levels slightly decreased after 13 treatment cycles. While the glucose area under the curve (AUC) (0–3 h) was similar in both groups during the OGTT, the insulin AUC(0–3 h) was less increased in the 20 EE/100 LNG group compared with the 30 EE/150 LNG group. None of the differences between the treatment groups for any of the carbohydrate metabolism variables were statistically significant at any time point. Both study treatments were safe and well tolerated by the volunteers. Conclusion Similar effects on the lipid and carbohydrate profiles were found for both preparations. The balanced one-third EE dose reduction in this new oral contraceptive caused slightly lower, but insignificant, changes in the lipid and carbohydrate variables compared with the reference treatment.

Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 μg ethinylestradiol and 150 μg levonorgestrel: a randomized trial

This trial was conducted to compare cycle control with vaginal ring a combined contraceptive vaginal ring, and a combined oral contraceptive (COC) delivering 30 mug ethinylestradiol (EE) and 150 mug levonorgestrel. This open-label, randomized, multi-centre, Phase III study involved adult women from 11 countries. Subjects were treated with either vaginal ring or a COC for 13 cycles (12 months). A total of 1030 subjects (vaginal ring, n=512; COC, n=518) comprised the intention-to-treat (ITT) population. The percentage of women in the ITT population who completed the trial was 70.9% for vaginal ring and 71.2% for the COC group. The incidence of breakthrough bleeding and spotting over cycles 2-13, the primary efficacy parameter, was lower with vaginal ring (range 2.0-6.4%) than the COC (range 3.5-12.6%), and for cycles 2 and 9 the lower incidence with vaginal ring was confirmed as statistically significant (P=0.003 and P=0.002 respectively). The incidence of intended bleeding was significantly higher over all cycles with vaginal ring (58.8-72.8%) than with the COC (43.4-57.9%). Cycle control with vaginal ring was excellent and superior to that of a COC containing 30 mug EE.

A randomized trial to compare 24 h versus 12 h double dose regimen of levonorgestrel for emergency contraception

Levonorgestrel (0.75 mg given for two doses 12 h apart) has been proven to be an effective regimen for emergency contraception when the first dose is given within 72 h of unprotected coitus. However, the dosing interval is inconvenient for those taking the first dose in the afternoon. We conducted a randomized study to evaluate two levonorgestrel dosing regimens for emergency contraception. Two doses of levonorgestrel 0.75 mg were administered with the first dose given up to 120 h after unprotected intercourse. The second dose was given 12 h later in the first regimen and 24 h later in the second regimen. We conducted a double-blind, randomized trial between 1997 and 2003 at five centres in China. A total of 2071 women requesting emergency contraception within 120 h of unprotected intercourse were recruited. They were randomized to receive two doses of 0.75 mg of levonorgestrel, given either 24 h apart or 12 h apart. Outcome was unknown for 53 women (24 in the 24 h group and 29 in the 12 h group). Among the remaining 2018 women, the crude pregnancy rate was 1.9% in the 24 h group [95% confidence interval (CI) 1.17-2.94] and 2.0% in the 12 h group (95% CI 1.19-2.99). The proportion of pregnancies prevented was estimated to be 72% in the 24 h group and 75% in the 12 h group. Side-effects were mild in both groups. The efficacy of the 12 h regimen declined significantly when there were further acts of intercourse after treatment (5.0 versus 1.0%, P<0.01). This was not observed in the 24 h group. Two doses of 0.75 mg levonorgestrel given either 24 or 12 h apart are effective for emergency contraception up to 120 h after unprotected intercourse. Further research to investigative more effective methods of emergency contraception is warranted.

Endometrial microstructure after long-term use of a 91-day extended-cycle oral contraceptive regimen

Objective To assess the effect on the endometrial microstructure of an extended-cycle oral contraceptive (OC) regimen containing ethinyl estradiol (EE) and levonorgestrel (LNG). Methodology Subjects received up to four cycles of a 91-day extended-cycle OC regimen (84 consecutive days of monophasic 30 μg EE/150 μg LNG followed by 7 days of placebo). Endometrial biopsies were performed prior to the initiation and at the completion of therapy. All endometrial samples were processed centrally and reviewed by three independent pathologists blinded to treatment groups. Results Endometrial biopsies were performed in 50 women. In general, samples taken after completion of therapy with no further hormonal exposure demonstrated rapid return to normal endometrial cycling. In contrast, the majority of subjects still on active extended hormonal OC therapy at the time of biopsy had inactive or atrophic endometrium. No intravascular blood clots were observed in any of the specimens. Conclusion The endometrial findings observed in this cohort of women treated with a 91-day extended-cycle OC regimen for up to 1 year showed no significant pathology. Additionally, the endometrium reverted quickly to normal cyclic changes in those subjects who, after completing therapy, elected not to continue with hormonal contraception.

Drospirenone in combination with estrogens: for contraception and hormone replacement therapy

Progesterone has a high affinity for the mineralocorticoid receptor and is an antagonist of aldosterone. Almost all synthetic progestogens are devoid of an antimineralocorticoid effect, and are unable to antagonize the salt-retaining effect of estrogens. This property could be one cause of the weight gain and increase in blood pressure associated with the use of combined oral contraceptives and, in some susceptible women, with postmenopausal hormone replacement therapy (HRT). This review illustrates the results of clinical studies with drospirenone, a new progestogen with antialdosterone activity.In normally menstruating women, 3 mg drospirenone per day, taken from day 5 to day 25 of the cycle, inhibits ovulation. A combination of 3 mg drospirenone with 30 μg ethinylestradiol (Yasmin®, Schering AG, Berlin, Germany) is a highly effective and well-tolerated oral contraceptive, with an overall Pearl Index of 0.57 and an adjusted Pearl Index of 0.09. In addition, this combination leads to mild natriuresis and a slight compensatory activation of the renin–aldosterone system. This effect hasbeen clinically demonstrated: compared with an oral contraceptive containing 30 μg ethinylestradiol and 150 μg levonorgestrel, 30 μg ethinylestradiol/3 mg drospirenone, given over 6 months, led to slight decreases in body weight and blood pressure.For postmenopausal HRT, 2 mg drospirenone was combined with 1 mg 17β-estradiol (Angeliq®, Schering AG, Berlin, Germany) for continuous treatment. To evaluate the endometrial safety of this combination, data were assessed from 520 postmenopausal women receiving 1 mg 17β-estradiol and drospirenone (1, 2 or 3 mg per day) for at least 100 weeks. There were no cases of hyperplasia or carcinoma during the entire study period, and 85–92% of women had an atrophic/inactive endometrium.Data from two studies, with a treatment duration of at least 6 months, demonstrated adecrease in mean systolic blood pressure of 1.8 mmHg and a decrease in mean diastolic blood pressure of 3.8 mmHg, after treatment with 1 mg 17β-estradiol/2 mg drospirenonefor 28 weeks. However, in a subgroup of slightly hypertensive women (initial blood pressure of more than 140/90 mmHg), the mean decrease in systolic bloodpressure after 28 weeks of treatment with 1 mg 17β-estradiol/2 mg drospirenonewas 12.5 mmHg, and the mean decrease in diastolic blood pressure was 9.4 mmHg.Since high blood pressure is a cardiovascular risk factor, the use of drospirenone may exert a beneficial effect in this regard. More prolonged studies need to be performed, in order to demonstrate whether negative cardiovascular end-points can be reduced by the new progestogen.In conclusion, drospirenone is not only a safe option for women using oral contraceptives or HRT, but it may offer new medical benefits, via its antimineralocorticoid and antialdosterone effects and its potential to decrease water retention and blood pressure.

A comparative study of monophasic oral contraceptives containing either drospirenone 3 mg or levonorgestrel 150 μg on premenstrual symptoms

This open-label randomized study compared the effects of two combined oral contraceptives (OCs) containing 3 mg drospirenone (DRSP)/30 μg ethinyl estradiol (EE) with 150 μg levonorgestrel (LNG)/30 μg EE on the prevalence and changes from baseline of premenstrual symptoms after six cycles. The symptoms were measured using the Women's Health Assessment Questionnaire. Subjects receiving DRSP/EE had fewer prevalence of premenstrual symptoms than those receiving LNG/EE after six cycles. A significantly lower score of negative affect category in the premenstrual phase was demonstrated in those receiving DRSP/EE more than LNG/EE. The DRSP/EE group showed a greater improvement of mean scores from baseline in the premenstrual phase compared with those who received LNG/EE on negative affect as seen in the items on anxiety, irritability, feeling sad or blue and weight gain in the category of water retention. In conclusion, OCs containing DRSP have beneficial effects in reducing the prevalence of premenstrual symptoms especially the symptoms of negative affect and weight gain, particularly when compared to LNG/EE. Hence, it should be recommended for women who are susceptible to these adverse symptoms.

Bone biochemical markers in adolescent girls using either depot medroxyprogesterone acetate or an oral contraceptive

Study objective To examine the relationship between biochemical markers of bone metabolism and hormonal contraception in adolescents. Design A prospective, observational design. Setting The study was conducted in four adolescent health clinics in a large metropolitan area. Participants The study population comprised healthy, postmenarcheal adolescent girls aged 12–18 initiating either medroxyprogesterone acetate (n = 53) or an oral contraceptive (OC) containing 20 μg ethinyl estradiol/100 μg levonorgestrel (n = 165) and those using no hormonal contraception (n = 152). Interventions None. Main outcome measures Serum bone specific alkaline phosphatase (BSAP), urinary deoxypyridinoline (DPD), and bone mineral density (BMD) at baseline and 12 months. Results At 12 month follow-up, serum BSAP levels were significantly higher ( P < 0.05) in the control group (40.4 U/L ± 1.03 SE), than in the DMPA group (35.2 U/L ± 1.05 SE) and the OC group (35.5 U/L ± 1.03 SE). There was a trend in urinary DPD levels to be higher ( P = 0.08) in the control group (9.9 nmol/mmol Cr ± 1.03 SE) than in the DMPA group (9.1 ± 1.05 SE) and the OC group (8.9 ± 1.03 SE). No relationship was found between the biochemical markers and BMD at the lumbar spine or the femoral neck. Conclusions Over 12 months, there was evidence of increased bone formation and resorption in the control group when compared to that in the DMPA and OC groups. This finding may indicate a suppression of bone metabolism in girls using DMPA or an OC containing 20 μg ethinyl estradiol/100 μg levonorgestrel.

Ovarian follicular development is initiated during the hormone-free interval of oral contraceptive use

We evaluated ovarian follicular development in women during compliant use of oral contraceptives (OC). Thirty-six healthy women received: [35 μg ethinyl estradiol (21)/180 μg norgestimate (7), 215 μg norgestimate (7), 250 μg norgestimate (7)]; [30 μg ethinyl estradiol (21)/150 μg desogestrel (21)]; or [20 μg ethinyl estradiol (21)/100 μg levonorgestrel (21)] for 3 consecutive 28-day cycles. Transvaginal ultrasonography was performed every third day to monitor follicular development. If a follicle reached ≥14 mm, ultrasonography was performed daily and blood drawn every other day to determine estradiol-17β concentrations. Seventeen of 36 women (47%) grew follicles ≥10 mm. Nine of the 17 women (53%) grew follicles ≥14 mm, in association with increased serum concentrations of estradiol-17β. Thirty-seven of 43 follicles ≥10 mm (86%) emerged during the hormone-free interval (HFI). No ovulations were observed. Our results supported the hypothesis that follicular development to an ostensibly ovulatory diameter occurs during compliant OC use, in association with loss of endocrine suppression during the HFI.

The effect on cartilage of different forms of application of postmenopausal estrogen therapy: comparison of oral and transdermal therapy

The effect on urine C-telopeptides of type II collagen (uCTX-II) of oral and transdermal estradiol treatment was compared using samples from two randomized, double-blind, placebo-controlled trials. A total of 171 healthy, Danish postmenopausal women, 45–65 years of age completed the 2-year study periods. The uCTX-II marker assessed cartilage degradation, and this response was compared with the effect on urine C-telopeptides of type I collagen (uCTX-I), considered a specific marker of bone resorption. Doses in the oral estradiol treatment groups (continuous combined therapy) were 1 mg 17-β-estradiol + 1 mg drosperinone or 1 mg 17-β-estradiol + 2 mg drosperinone or 1 mg 17-β-estradiol + 3 mg drosperinone or placebo. Doses in the transdermal estradiol treatment groups (continuous combined therapy) were 45 μg 17-β-estradiol + 30 levonorgestrel or 45 μg 17-β-estradiol + 40 μg levonorgestrel or placebo. The effect of oral and transdermal estradiol therapy on cartilage degradation was reflected as a decrease of 19–30% in uCTX-II ( P = 0.02 and P = 0.003 vs. placebo) after 1 year of treatment. uCTX-I decreased 70% ( P < 0.0001 vs. placebo) reflecting a pronounced effect on bone resorption that was consistent with a 2-year increase in spine and hip BMD of 7–8% and 4–6%, respectively. The results indicate that different regimens of postmenopausal HRT both have an effect on cartilage and bone thus protecting against osteoporosis and osteoarthritis (OA). However, long-term clinical trials are needed to further investigate this issue.

Effect of four oral contraceptives on hemostatic parameters

This is the first double-blind, controlled, randomized study comparing the effect of different estrogen components in oral contraceptives (OCs) on hemostasis variables. Four groups of 25 women each were treated for six cycles with monophasic combinations containing 21 tablets with either 30 μg ethinylestradiol (EE) + 2 mg dienogest (DNG) (30EE/DNG), 20 μg EE + 2 mg DNG (20EE/DNG), 10 μg EE + 2 mg estradiol valerate (EV) + 2 mg DNG (EE/EV/DNG) or 20 μg EE + 100 μg levonorgestrel (LNG) (EE/LNG). Blood samples were taken on Days 21–26 of the control cycle and on Days 18–21 of the first, third and sixth treatment cycle. Treatment with all four OCs caused an increase in levels of fibrinogen, prothrombin fragment 1+2, D-dimer, plasminogen, plasmin-antiplasmin complex and an increase in protein C activity, a decrease in antithrombin activity, tissue-plasminogen activator (t-PA) and plasminogen activator inhibitor (PAI), and a slight decrease in the sensitivity to activated protein C, but no significant change in that of the thrombin-antithrombin complex. In users of the DNG-containing OCs, the reduction in total and free protein S, and in t-PA and PAI was dependent on the EE dose, while factor VII activity was elevated, but not significantly different from EE/LNG. The results are in agreement with those of previous studies. The effects of EE/EV/DNG on total and free protein S and on t-PA and PAI were lower than those of 20EE/DNG, suggesting that the impact of 2 mg EV on several hemostasis variables is less than that of 10 μg EE. The results show an antagonistic effect of LNG on the EE-induced rise of factor VII activity and fragment 1+2 and on the EE-dependent reduction of total and free protein S.

Levonorgestrel and 17β-estradiol given transdermally for the prevention of postmenopausal osteoporosis

Aim: To evaluate the efficacy and safety of a new transdermal continuous combined hormone replacement therapy (HRT) for the prevention of postmenopausal osteoporosis. Methods: 212 osteopenic (lumbar spine and/or hip (femoral neck) bone mineral density (BMD) between −1.0 and −2.5 S.D. of the premenopausal mean value) postmenopausal women aged 45–65 years participated in a 2-year prospective study. Treatments were 45 μg 17β-estradiol combined with 30 ( n = 69) or 40 μg ( n = 72) levonorgestrel daily or placebo ( n = 71) given as a 7-day patch. All received a daily supplement of 500 mg calcium. BMD at lumbar spine (L2–L4), hip and total body, as well as blood and urinary biochemical markers of bone turnover (serum osteocalcin (sOC), serum bone-specific alkaline phosphatase (sBSAP), urinary calcium (uCa) and urinary CrossLaps (uCTX)) were measured regularly. Results: BMD at the lumbar spine, hip and total body increased by 8, 6 and 3% ( P < 0.001), respectively, in the hormone groups versus placebo. The bone markers all decreased accordingly (sOC: 37%, sBSAP: 34% and uCTX: 65% from baseline (all P < 0.001)), except for uCa that did not change significantly. No significant dose-related effect of levonorgestrel was found. Vaginal bleeding/spotting decreased from 48 to 25% of the HRT-treated women during the study period. Skin tolerance was good in 84% of the women with no difference between the study groups. No incidences of endometrial hyperplasia, uterine or mammary cancer occurred. Conclusion: The transdermal combination of 17β-estradiol and levonorgestrel has a positive effect on BMD in an osteopenic postmenopausal population. Furthermore, a high safety profile was observed.

Mechanisms of action of mifepristone and levonorgestrel when used for emergency contraception.

An emergency contraceptive method is used after coitus but before pregnancy occurs. The use of emergency contraception is largely under-utilized worldwide. One of the main barriers to widespread use is concern about the mechanism of action. Recently, treatment with either 10 mg mifepristone or 1.5 mg of levonorgestrel has emerged as the most effective hormonal method for emergency contraception with very low side-effects. However, the knowledge of the mechanism of action of mifepristone and levonorgestrel in humans, when used for contraceptive purposes and especially for emergency contraception, remains incomplete. The objective of this review is to summarize available data on the effects of mifepristone and levonorgestrel on female reproductive functions relevant to the emergency use of the compounds. When summarized, available data from studies in humans indicate that the contraceptive effects of both levonorgestrel and mifepristone, when used in single low doses for emergency contraception, involve either blockade or delay of ovulation, due to either prevention or delay of the LH surge, rather than to inhibition of implantation.

Cycle control, quality of life and acne with two low-dose oral contraceptives containing 20 $mu;g ethinylestradiol

Objectives Poor cycle control and tolerability can be reasons for irregular pill intake. This study compared the tolerability of two low-dose oral contraceptives and their effect on cycle control. Methods In this open, group-comparative, randomized multicenter trial in Germany and the Netherlands, women received either 20 μg ethinylestradiol plus 150 μg desogestrel (20EE/DSG; n = 500) or 20 μg ethinylestradiol plus 100 μg levonorgestrel (20EE/LNG; n = 498) for six treatment cycles. Cycle control, dysmenorrhea and premenstrual syndrome (PMS) were assessed using diary cards. Tolerability was assessed using the self-administered questionnaires Psychological General Well-Being Index (PGWBI) and the Profile of Mood States (POMS). Acne was assessed by objective (acne counts) and subjective (no, moderate, mild, severe) acne scoring of the facial area at baseline and treatment cycles 1, 3 and 6. Results A total of 404 (78.1%) and 384 (75.3%) women in the 20EE/DSG and 20EE/LNG groups, respectively, completed the trial. The occurrence rate of irregular bleeding and spotting was statistically significantly higher with 20EE/LNG than with 20EE/DSG (0.18 vs. 0.13; p < 0.05). The mean number of bleeding-spotting days per cycle was statistically significantly higher with 20EE/LNG than with 20EE/DSG (0.63 vs. 0.48; p < 0.05). Early withdrawal bleeding was more frequent with 20EE/LNG (0.15 vs. 0.08; p < 0.005), whereas continued withdrawal bleeding was more frequent with 20EE/DSG (0.32 vs. 0.45; p < 0.001); absence of withdrawal bleeding was comparable (0.06 vs. 0.04, respectively). Thirteen subjects in the 20EE/LNG group and three in the 20EE/DSG group discontinued due to unacceptable bleeding (p < 0.05). Dysmenorrhea and PMS decreased comparably in both groups. There were no differences between groups for the mean total scores of PGWBI or POMS at all time-points. Fewer acne lesions were counted with 20EE/DSG vs. 20EE/LNG after six cycles (p < 0.05). The subjective acne scores supported this finding. Conclusions 20EE/DSG provided better cycle control than 20EE/LNG with less treatment discontinuation due to unacceptable bleeding. There were no apparent differences between the two groups regarding tolerability and quality of life. There was less acne with 20EE/DSG.

Cycle control, quality of life and acne with two low-dose oral contraceptives containing 20 μg ethinylestradiol

Objectives Poor cycle control and tolerability can be reasons for irregular pill intake. This study compared the tolerability of two low-dose oral contraceptives and their effect on cycle control. Methods In this open, group-comparative, randomized multicenter trial in Germany and the Netherlands, women received either 20 μg ethinylestradiol plus 150 μg desogestrel (20EE/DSG; n = 500) or 20 μg ethinylestradiol plus 100 μg levonorgestrel (20EE/LNG; n = 498) for six treatment cycles. Cycle control, dysmenorrhea and premenstrual syndrome (PMS) were assessed using diary cards. Tolerability was assessed using the self-administered questionnaires Psychological General Well-Being Index (PGWBI) and the Profile of Mood States (POMS). Acne was assessed by objective (acne counts) and subjective (no, moderate, mild, severe) acne scoring of the facial area at baseline and treatment cycles 1, 3 and 6. Results A total of 404 (78.1%) and 384 (75.3%) women in the 20EE/DSG and 20EE/LNG groups, respectively, completed the trial. The occurrence rate of irregular bleeding and spotting was statistically significantly higher with 20EE/LNG than with 20EE/DSG (0.18 vs. 0.13; p < 0.05). The mean number of bleeding-spotting days per cycle was statistically significantly higher with 20EE/LNG than with 20EE/DSG (0.63 vs. 0.48; p < 0.05). Early withdrawal bleeding was more frequent with 20EE/LNG (0.15 vs. 0.08; p < 0.005), whereas continued withdrawal bleeding was more frequent with 20EE/DSG (0.32 vs. 0.45; p < 0.001); absence of withdrawal bleeding was comparable (0.06 vs. 0.04, respectively). Thirteen subjects in the 20EE/LNG group and three in the 20EE/DSG group discontinued due to unacceptable bleeding (p < 0.05). Dysmenorrhea and PMS decreased comparably in both groups. There were no differences between groups for the mean total scores of PGWBI or POMS at all time-points. Fewer acne lesions were counted with 20EE/DSG vs. 20EE/LNG after six cycles (p < 0.05). The subjective acne scores supported this finding. Conclusions 20EE/DSG provided better cycle control than 20EE/LNG with less treatment discontinuation due to unacceptable bleeding. There were no apparent differences between the two groups regarding tolerability and quality of life. There was less acne with 20EE/DSG.