Body weight change during use of a monophasic oral contraceptive containing 20 μg ethinylestradiol and 75 μg gestodene with a comparison of the women who completed versus those who prematurely discontinued intake

Objectives: Evaluation of the impact of an oral contraceptive on body weight with a comparison of women who completed versus women who prematurely discontinued intake. Methods: Data on body weight were retrospectively analyzed from four large prospective clinical trials with an oral contraceptive containing 20 μg ethinylestradiol and 75 μg gestodene (EE/GSD). A total of 1971 young fertile women were included in the evaluation, and 1467 completed 12 cycles. Results: We found no clinically relevant change of body weight during treatment with an oral contraceptive containing 20 μg ethinylestradiol and 75 μg gestodene in the vast majority of users after 12 treatment cycles. The mean change of body weight was less than 0.3 kg in this time period for all users. Nearly 70% of women experienced a minor change in their body weight of ± 2 kg. An additional 13% lost more than 2 kg body weight in the course of 12 treatment cycles. A total of 11% increased their weight by 2-4 kg. A total of 1255 (85.5%) of women had a body mass index (BMI) of ≤ 25 at baseline compared to 1253 (85.4%) after 12 cycles of treatment. There was no significant difference in the change of body weight between the women completing 12 cycles of treatment and those who prematurely discontinued EE/GSD. Conclusions: This retrospective analysis confirms that there was only a negligible change of body weight during intake of an oral contraceptive containing 20 μg ethinylestradiol and 75 μg gestodene. There was no difference in weight change between the women completing the study or discontinuing intake.     

Blood pressure stability in a normotensive population during intake of a monophasic oral contraceptive containing 20 microg ethinylestradiol and 75 g gestodene.

OBJECTIVES: Evaluation of the impact of a monophasic gestodene-based oral contraceptive on blood pressure in a population that was normotensive at baseline. METHODS: Data on blood pressure were retrospectively analyzed from four large prospective clinical phase III trials with an oral contraceptive containing 20 microg ethinylestradiol and 75 microg gestodene. A total of 1342 young fertile women were evaluated after 12 treatment cycles. RESULTS: The mean systolic and diastolic blood pressure did not change during treatment. Approximately 89% of women were normotensive at baseline and 93% at the end of the treatment period. Only a few women (< or = 1%) were hypertensive at baseline; an increase in this prevalence was not found after 12 cycles of oral contraceptive use. The number of women who experienced a blood pressure increase was almost identical to the number who experienced a decrease. Approximately 90% of women had either a negligible blood pressure change of maximal +/- 10 mmHg or a decrease. CONCLUSIONS: The findings of this retrospective analysis confirm that monophasic gestodene has a negligible effect on blood pressure in users who were normotensive before treatment began.     

Effect of a combined oral contraceptive containing 20 microg ethinyl estradiol and 75 microg gestodene on hemostatic parameters.

The effects of a combined oral contraceptive (COC) containing 20 microg ethinyl estradiol (EE) and 75 microg gestodene (GSD) on prothrombin activity (PA), activated partial thromboplastin time (APTT), thrombin time (TT), platelet number, fibrinogen, antithrombin III (ATIII), protein C, protein S and D-dimer were evaluated over 6 months in 23 young, healthy women. Laboratory assessments were performed prior to initiation of COC use (pretreatment) and after 3 and 6 months of use. Results showed no significant changes in fibrinogen, protein C, ATIII or D-dimer during COC use, compared with pretreatment values. The increase in platelet count, decreases in protein S level, PA and APTT, and the prolongation of TT were significant. In conclusion, the use of a COC containing 20 microg EE and 75 microg GSD did not cause any significant changes in the hemostatic parameters studied that could be suggestive of a higher prothrombotic risk. Further studies with a larger sample size are necessary in order to obtain conclusive data.     

Plasma concentrations of endogenous hormones during one regular treatment cycle with a low-dose oral contraceptive and during two cycles with deliberate omission of two tablets.

In this open, prospective, phase-I study we closely monitored levels of endogenous progesterone, 17beta-estradiol, luteinizing hormone (LH) and follicle stimulating hormone in six healthy women. We determined plasma concentrations every 1-3 days during one untreated baseline cycle and during the first treatment cycle with regular pill intake of an oral contraceptive containing 30 microg ethinylestradiol plus 75 microg gestodene. During the following two treatment cycles, two tablets were deliberately omitted (in cycle 2 on days 6/7 and in cycle 3 on days 11/12). All but possibly one volunteer ovulated in the untreated pre-cycle, as concluded from LH peaks followed by marked increases of progesterone. During the regular first treatment cycle and even after deliberate omission of two tables in treatment cycles 2 and 3, the progesterone and estradiol levels remained low, so that we concluded that no ovulation took place. However, two volunteers showed some sort of LH peak in the first regular treatment cycle and all women showed LH increases of > 40 microg/ml in at least one omission cycle. In ten out of 12 cycles, omissions of pill intake were followed by an episode of intermenstrual bleeding. In conclusion, we have shown that, after omission of two consecutive oral contraceptive tables, the endogenous hormone parameters did not provide evidence for ovulation. Although this provides confirmation of the robustness of this oral contraceptive towards non-compliance, the widely published practical recommendations should be followed.     

Comparison of the effect on acne with a combiphasic desogestrel-containing oral contraceptive and a preparation containing cyproterone acetate.

OBJECTIVE: To investigate the effect of a combiphasic oral contraceptive containing ethinylestradiol and desogestrel (combiphasic EE/DSG) on acne, compared with a preparation containing ethinylestradiol and cyproterone acetate (EE35/CPA). METHODS: An open, randomized, group-comparative, multicenter study was carried out, with 172 women randomized to treatment with either combiphasic EE/DSG (25 microg desogestrel and 40 microg ethinylestradiol for 7 days followed by 125 microg desogestrel and 30 microg ethinylestradiol for 15 days) or EE35/CPA (2.0 mg cyproterone acetate and 35 microg ethinylestradiol for 21 days). Assessments were performed at pretreatment and after cycles 3 and 6. RESULTS: The number of comedones, papules, pustules and nodules significantly decreased in both groups over the 6-month study. Compared with pretreatment (= 100%), the relative numbers of comedones, papules, pustules and nodules at cycle 6 significantly decreased to 37%, 38%, 19% and 12.5% in the combiphasic EE/DSG group and to 24%, 36%, 17% and 1% in the EE35/CPA group, respectively. All reductions were statistically significant (p < or = 0.003) at both cycles 3 and 6, except for nodules at cycle 6 with combiphasic EE/DSG, which probably resulted from differences between the treatment groups at baseline. There were no statistically significant differences between the two treatments. In both groups, the majority of women with severe acne shifted to a less severe acne category. CONCLUSIONS: Combiphasic EE/DSG progressively reduced the number and severity of acne lesions during the six cycles of treatment. The reduction in acne with the combiphasic oral contraceptive was comparable to a preparation containing the antiandrogen cyproterone acetate.     

Blood pressure stability in a normotensive population during intake of a monophasic oral contraceptive containing 20 μg ethinylestradiol and 75 g gestodene

Objectives Evaluation of the impact of a monophasic gestodene-based oral contraceptive on blood pressure in a population that was normotensive at baseline. Methods Data on blood pressure were retrospectively analyzed from four large prospective clinical phase III trials with an oral contraceptive containing 20 μg ethinylestradiol and 75 μg gestodene. A total of 1342 young fertile women were evaluated after 12 treatment cycles. Results The mean systolic and diastolic blood pressure did not change during treatment. Approximately 89% of women were normotensive at baseline and 93% at the end of the treatment period. Only a few women (≤ 1%) were hypertensive at baseline; an increase in this prevalence was not found after 12 cycles of oral contraceptive use. The number of women who experienced a blood pressure increase was almost identical to the number who experienced a decrease. Approximately 90% of women had either a negligible blood pressure change of maximal ± 10 mmHg or a decrease. Conclusions The findings of this retrospective analysis confirm that monophasic gestodene has a negligible effect on blood pressure in users who were normotensive before treatment began.     

A large observational clinical evaluation of a desogestrel-containing combiphasic oral contraceptive in Germany.

OBJECTIVE: The aim of this observational study was to assess the influence of a new combiphasic oral contraceptive on cycle control, tolerability and acne in a large cohort of women who wanted to switch from their previous oral contraceptive. METHODS: A total of 2,280 women were enrolled in this clinical evaluation at 232 centers in Germany. All women switched from their previous pill to a combiphasic oral contraceptive containing ethinylestradiol and desogestrel (combiphasic EE/DSG; comprising 25 microg desogestrel and 40 microg ethinylestradiol for 7 days followed by 125 microg desogestrel and 30 microg ethinylestradiol for 15 days and then a 6-day pill-free interval) for three cycles. RESULTS: Most women (53%) had previously used a monophasic oral contraceptive containing 20 or 30-35 microg ethinylestradiol. The most frequent reasons for switching were bleeding irregularities (41% of women), other menstrual disorders (27%) and migraine/headache (10%). After switching to combiphasic EE/DSG, cycle control improved significantly: the incidences of spotting and breakthrough bleeding decreased from 33% and 23% of women, respectively, before the start of the study, to 7% and 3% of women at the end of the study period. At the end of the study, acne was no longer present in 37% of the 592 women who had acne at the start of the study, and subjective complaints such as headaches were less frequent than before. Most women were satisfied or very satisfied with the combiphasic oral contraceptive and 89% wished to continue using it. CONCLUSIONS: The results of this observational clinical evaluation indicate that in everyday use, for women who wish to switch from another oral contraceptive, combiphasic EE/DSG is an effective and well-tolerated oral contraceptive, which improves cycle control and has a beneficial effect on acne.     

A pharmacokinetic study with a low-dose oral contraceptive containing 20 microg ethinylestradiol plus 100 microg levonorgestrel.

This study investigated the pharmacokinetics of a dose-reduced oral contraceptive containing 20 microg ethinylestradiol (EE) + 100 microg levonorgestrel (LNG) in 18 young, healthy females. Serum levels of EE and LNG were determined after single and repeated daily oral administration over three treatment cycles, each consisting of 21 treatment days followed by a 7-day treatment-free period. Additionally, the time courses of sex hormone-binding globulin (SHBG), corticoid-binding globulin (CBG) and total and free testosterone serum levels were analyzed. Both active ingredients were rapidly absorbed and maximum concentrations in serum were reached between, on average, 1 and 2 h after single and multiple administrations, respectively. Concentrations of EE increased during repeated daily administration. An approximate two-fold accumulation was calculated based on the comparison of EE area under the curve (AUC) (0-24 h) values determined after the first and the last tablet administration within a treatment cycle. LNG serum concentrations also increased during repeated daily administration, reaching steady-state levels after about 11 days. Based on the comparison of AUC (0-24 h) values determined after the first and the last tablet administration, LNG accumulated approximately by a factor of 3 within a treatment cycle. Steady-state pharmacokinetics of LNG were similar at the end of the first and the third treatment cycles, indicating no further accumulation of LNG beyond a treatment cycle under long-term use of this combined oral contraceptive. The clearance and volume of distribution of LNG decreased and the terminal half-life increased after repeated daily administration, compared with single administration. These effects have also been reported for other LNG/EE combinations. SHBG serum concentrations increased during repeated daily intake by, on average, 1.5-1.6-fold, and for CBG, an average increase of 1.4-1.8-fold was found. Although free testosterone concentrations declined during repeated daily administration by about 40%, total testosterone remained relatively unchanged at a low level. In conclusion, the pharmacokinetics of EE and LNG determined in the present study were in good agreement with those previously reported for 30 microg EE + 150 microg LNG, taking the 33% dose reduction into account.     

A Canadian multicentre prospective study on the effects of an oral contraceptive containing 3 mg drospirenone and 30 microg ethinyl oestradiol on somatic and psychological symptoms related to water retention and on body weight.

OBJECTIVES: To evaluate the effects of an oral contraceptive containing 3 mg drospirenone (DRSP) and 30 microg ethinyl oestradiol (EE) on somatic and psychological symptoms related to water retention, and on body weight. METHODS: This prospective study was performed in 26 centres in Canada over six treatment cycles. The first primary efficacy variable was the individual change in the water retention score of the Moos Menstrual Distress Questionnaire (MDQ) from baseline to the final examination in women with significant somatic symptoms related to water retention (n = 43). The second primary target variable was the change in body weight (n = 305). RESULTS: Forty-three women met the criteria for the first primary target variable. In the premenstrual phase, the score decreased from 6.49 (SEM 0.45) at baseline to 3.19 (SEM 0.54) at the final examination (p = 0.0001). The data for the menstrual phase were 4.70 (SEM 0.30) at baseline and 2.35 (SEM 0.32) at the final examination (p < 0.0001). Baseline data from 299 women were assessed for the second primary target variable. Body weight did not change significantly, having increased only by 0.14 kg (SEM 0.13) at the final visit (p = 0.3082). CONCLUSION: An oral contraceptive containing 3 mg DRSP and 30 microg EE significantly reduced the clinical symptoms of water retention. Body weight did not change.     

Clinical trial of a monophasic estroprogestin oral formulation containing 20 micrograms ethinyl estradiol and 75 micrograms gestodene.

The attempt to decrease the hormonal components of combined estrogen/progestin-containing oral formulations has led to use of low-dose formulations. The monophasic formulation containing ethinyl estradiol 20 micrograms (EE20) plus gestodene 75 micrograms (GSD75) was studied in an open, non-comparative, multicenter, clinical trial investigating its efficacy, safety, effects on body weight, blood pressure and sexual function. To evaluate the impact on sexual function, the Golombok Rust Questionnaire on Sexual Satisfaction (GRISS) was used. The study population comprised 216 women treated for 1 year. The EE20/GSD75 formulation did not show any significant effect on blood pressure, hematological parameters, body weight or sexual function. The treatment was well tolerated with a high compliance rate by the patients, with a low rate of estrogen-dependent symptoms. Moreover, there was no overall effect on sexual function, with no disturbance of sexual behavior or activity. In conclusion, our data show that the EE20/GSD75 has a very good tolerability profile, without any significant side-effects.     

Cytological aspects of the nasal respiratory epithelium in reproductive-age women taking oral contraceptives.

OBJECTIVE: To determine the effects of monophasic oral contraceptives on the nasal respiratory epithelium in premenopausal women. DESIGN: Prospective open clinical trial. SETTING: Outpatient Family Planning Centre. PATIENT(S): Eighty-eight premenopausal women, with ovulatory cycle, who were planning to take oral contraceptives. INTERVENTION(S): Baseline endovaginal ultrasound examination and blood test to measure serum progesterone to confirm ovulatory cycle. Thirty-eight women on pill containing 30 microg ethinylestradiol (EE) plus 75 microg gestodene, and 35 women on pill containing 15 microg ethinylestradiol plus 60 microg gestodene. MAIN OUTCOMES/MEASURE(S): Cytological changes on the nasal respiratory epithelium evaluated with the maturation index performed during the follicular, periovular, and luteal phases of the menstrual cycle, and on the sixth cycle of pill intake. RESULT(S): Hematoxylin-eosin staining for the maturation index showed similar trophic cytological aspects between the nasal and vaginal epithelium during the menstrual cycle and pill usage. Both the nasal and vaginal cytological samples showed higher maturation indexes during both the follicular and the periovular phases than during the luteal phase. Women on pill containing 15 microg EE showed lower trophic aspects in the nasal cytological samples compared with those on pill with 30 microg EE. CONCLUSION(S): Along with the vaginal cells, the nasal respiratory epithelium is an ovarian steroid target. The maturation index of the nasal respiratory epithelium seems to depend on the variation of the ovarian steroids during the menstrual cycle and on the iatrogenic effects of oral contraceptives.     

Clinical trial of a monophasic estroprogestin oral formulation containing 20 μg ethinyl estradiol and 75 μg gestodene

The attempt to decrease the hormonal components of combined estrogen/progestin-containing oral formulations has led to use of low-dose formulations. The monophasic formulation containing ethinyl estradiol 20 μg (EE20) plus gestodene 75 μg (GSD75) was studied in an open ,non-comparative ,multicenter ,clinical trial investigating its efficacy ,safety ,effects on body weight ,blood pressure and sexual function. To evaluate the impact on sexual function ,the Golombok Rust Questionnaire on Sexual Satisfaction (GRISS) was used. The study population comprised 216 women treated for 1 year. The EE20/GSD75 formulation did not show any significant effect on blood pressure ,hematological parameters ,body weight or sexual function. The treatment was well tolerated with a high compliance rate by the patients, with a low rate of estrogen-dependent symptoms. Moreover ,there was no overall effect on sexual function ,with no disturbance of sexual behavior or activity. In conclusion ,our data show that the EE20/GSD75 has a very good tolerability profile ,without any significant side-effects.     

A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel.

OBJECTIVE: To assess the contraceptive reliability, cycle control and tolerance of a new monophasic oral contraceptive (Yasmin) containing 30 microg ethinylestradiol and 3 mg drospirenone and compare it with a preparation containing an equal dose of ethinylestradiol combined with 150 microg desogestrel (Marvelon). METHODS: A multicenter, open-label, randomized study was carried out in 26 European centers. Contraceptive efficacy, cycle control and tolerance (including body weight, blood pressure and heart rate) were assessed over 26 cycles, plus a 3-month follow-up period. RESULTS: Of 900 women who were randomized, 887 started treatment and 627 completed the 26 cycles plus follow-up (310 in the ethinylestradiol/drospirenone group and 317 in the ethinylestradiol/desogestrel group). Both study preparations were found to be effective with regard to contraceptive reliability and cycle control was good. There were six pregnancies (three in each group), but none were considered to have been the result of method failures. The subjective and objective tolerances were good in both groups. A statistically significant difference was found in body weight changes between the two groups. While there was an increase in mean body weight in the ethinylestradiol/desogestrel group from cycle 5 onward, the mean body weight per cycle in the ethinylestradiol/drospirenone group was slightly below the baseline value throughout the study. The incidence ofpremenstrual symptoms was higher in the ethinylestradiol/drospirenone group than in the ethinylestradiol/desogestrel group during the 6 months prior to the study, but lower during treatment. The rates ofdysmenorrhea were identical under both treatments but the symptoms were more often mild and less often severe in the ethinylestradiol/drospirenone group. CONCLUSION: The combination of 30 microg ethinylestradiol combined with 3 mg drospirenone provides effective oral contraception and good cycle control, and is well tolerated. Ethinylestradiol/drospirenone had a more favorable effect on body weight than ethinylestradiol/desogestrel, with the mean body weight remaining lower than baseline for the majority of the women.     

Plasma concentrations of endogenous hormones during one regular treatment cycle with a low-dose oral contraceptive and during two cycles with deliberate omission of two tablets

In this open, prospective, phase-I study we closely monitored levels of endogenous progesterone, 17β-estradiol, luteinizing hormone (LH) and follicle stimulating hormone in six healthy women. We determined plasma concentrations every 1–3 days during one untreated baseline cycle and during the first treatment cycle with regular pill intake of an oral contraceptive containing 30?μg ethinylestradiol plus 75?μg gestodene. During the following two treatment cycles, two tablets were deliberately omitted (in cycle 2 on days 6/7 and in cycle 3 on days 11/12). All but possibly one volunteer ovulated in the untreated pre-cycle, as concluded from LH peaks followed by marked increases of progesterone. During the regular first treatment cycle and even after deliberate omission of two tables in treatment cycles 2 and 3, the progesterone and estradiol levels remained low, so that we concluded that no ovulation took place. However, two volunteers showed some sort of LH peak in the first regular treatment cycle and all women showed LH increases of >?40?μg/ml in at least one omission cycle. In ten out of 12 cycles, omissions of pill intake were followed by an episode of intermenstrual bleeding. In conclusion, we have shown that, after omission of two consecutive oral contraceptive tables, the endogenous hormone parameters did not provide evidence for ovulation. Although this provides confirmation of the robustness of this oral contraceptive towards non-compliance, the widely published practical recommendations should be followed.     

A randomized, controlled trial of a low-dose contraceptive containing 20 microg of ethinyl estradiol and 100 microg of levonorgestrel for acne treatment

OBJECTIVE: To evaluate the efficacy of a low-dose oral contraceptive (OC) containing 100 microg of levonorgestrel (LNG) and 20 microg of ethinyl estradiol (EE) compared with placebo for the treatment of moderate acne. DESIGN: Multicenter, randomized, double-blind, placebo-controlled clinical trial. SETTING: Outpatient dermatology clinics. PATIENT(S): Women (> or =14 years old; n = 350) with normal menstrual cycles and moderate acne were randomized to receive LNG/EE or placebo for six cycles.Intervention(s): Twenty microg of EE and 100 microg of LNG. MAIN OUTCOME MEASURE(S): Acne lesion counts and clinician global assessment were performed at baseline and at each cycle. Patient self-assessment was carried out at baseline and at cycles 4 and 6; blood pressure and weight were measured at baseline and at cycles 1, 3, and 6. RESULT(S): Inflammatory, noninflammatory, and total lesion counts at cycle 6 with LNG/EE were significantly lower compared to placebo. Patients in the LNG/EE group also had significantly better clinician global and patient self-assessment scores than those in the placebo group at cycle. Changes in weight from baseline were similar between patients in the LNG/EE and placebo groups at all measured time points. CONCLUSION(S): This double-blind, placebo-controlled study demonstrates that a low-dose OC containing 20 microg of EE and 100 microg of LNG is an effective and safe treatment for moderate acne.     

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 Jig gestodene and 20 fig 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. Predecidual 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 μ/20 μg, 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.     

Effects of two combined oral contraceptives containing ethinyl estradiol 30 μg combined with either gestodene or drospirenone on hemostatic parameters,lipid profiles and blood pressure

Objective  The aim of this study is to compare the effect of ethinyl estradiol 0.03 mg/gestodene 0.075 mg (EE/GSD) with ethinylestradiol 0.03 mg/drospirenone 3 mg (EE/DRSP) administered according to conventional 21/7 regimen on body mass index (BMI), blood pressure (BP), lipid metabolism and hemostatic parameters. Method  In this study, 160 healthy women were randomized to EE/GSD mg or EE/DRSP for 12 months. Mean differences in BMI, high density lipoprotein-cholesterol (HDL-C) and low density lipoprotein-cholesterol (LDL-C), total cholesterol (TC) levels and BP compared to baseline were assessed. Results  One hundred and forty-five (89%) of the women completed all 12 treatment cycles. The subjects randomly assigned into two treatment groups. Group EE/GSD (n = 71) and group EE/DRSP (n = 72). In group B, BMI values were significantly lower than baseline at the sixth cycle. DRSP/EE had more favorable effects on BP than GSD/EE with the mean systolic and diastolic BPs remaining lower in the DRSP/EE group. The difference between the two preparations was not statistically significant at the end of the study. TC levels remained similar in both groups throughout the study period. In both groups LDL-C levels decreased, triglyceride and HDL-C levels significantly increased from baseline levels. These changes result in increasing HDL-C/LDL-C ratio, demonstrating anti-atherogenic effect. Menstrual cycle patterns and the incidence of adverse events were similar between groups. The duration of withdrawal bleeding decreased during the study for both groups and was similar. Conclusion  The EE/DRSP regimen provides good cycle control with reliable contraceptive efficacy and low incidence of adverse events. Compared with the EE/GSD preparation, the EE/DRSP preparation demonstrated a more favorable effect on BMI and BP with the mean BMI and mean BP remaining lower than baseline mean. The new formulation may be especially beneficial for women susceptible to body weight gain and rise in BP.     

Effects of low-dose oral contraceptives on body weight: results of a randomized study of up to 13 cycles of use

OBJECTIVE: To compare the effect of 2 oral contraceptives (OCs) on body weight. STUDY DESIGN: A randomized, parallel-group, multicenter study of 1,723 women taking an OC with norgestimate (NGM) 180/215/250 microg/ethinyl estradiol (EE) 25 microg vs. 1,171 women taking on OC with norethindrone acetate 1 mg/EE 20 microg for 6-13 cycles was performed. Body weight changes between baseline and cycle 6 and baseline and cycle 13 were analyzed. Analysis included not only changes in mean body weight but also the distribution of changes that were within 5% of baseline weight, 5-10% of baseline weight and > 10% of baseline weight. Only the 10% change was felt to be clinically significant. RESULTS: The distribution of body weight changes did not statistically differ between the 2 OC groups for any parameter measured. The mean weight change after 6 months for the NGM/EE and norethindrone acetate/EE groups was +0.71 kg and +0.57 kg, respectively. At 13 cycles for the NGM/EE and norethindrone acetate/ EE groups, the mean body weight change was +0.93 kg and +0.62 kg, respectively. Only 0.3% of subjects in both OC groups experienced a 10% change in weight. CONCLUSION: Use of OCs does not substantially affect body weight for most women.     

Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone.

OBJECTIVE: To assess the contraceptive reliability, cycle control and tolerability of a new monophasic oral contraceptive containing 30 g ethinylestradiol plus 3 mg drospirenone (Yasmin, Schering AG, Berlin, Germany), it was compared with an established oral contraceptive containing 30 g ethinylestradiol plus 150 g desogestrel (Marvelon, NV Organon, Oss, The Netherlands). METHODS: A randomized, open-label, 13-cycle study was performed at 80 European centers. Contraceptive reliability, cycle control, blood pressure, body weight, the incidence of adverse events and skin condition were assessed during 13 cycles of oral contraceptive use, and at follow-up. Subjects recorded body weight on three consecutive days pretreatment and weekly thereafter. RESULTS: Of 2069 women who started the study and received the trial preparations in a ratio of 4:1 (ethinylestradiol/drospirenone, n = 1657; ethinylestradiol/desogestrel, n = 412), 1615 completed the 13 cycles plus follow-up, providing data for over 23,000 evaluable cycles. Eleven pregnancies occurred during treatment, only one of which (in the ethinylestradiol/drospirenone group) could not be ascribed to user failure or interaction with other factors. Both preparations provided effective contraception and cycle control. Pre-existing acne and seborrhea were improved and blood pressure was essentially unchanged. The two treatments differed in their effect on body weight, the difference being statistically significant. In the ethinylestradiol/drospirenone group, there was a distinct decrease over the whole treatment phase, while a subtle and less distinct decrease was documented in the ethinylestradiol/desogestrel group. CONCLUSIONS: The combination of 30 g ethinylestradiol/3 mg drospirenone provides effective oral contraception, excellent cycle control, good tolerability and a level of weight loss that may have a significant beneficial effect on compliance in women with a tendency to weight gain due to water retention.     

A large observational clinical evaluation of a desogestrel-containing combiphasic oral contraceptive in Germany

Objective The aim of this observational study was to assess the influence of a new combiphasic oral contraceptive on cycle control, tolerability and acne in a large cohort of women who wanted to switch from their previous oral contraceptive. Methods A total of 2280 women were enrolled in this clinical evaluation at 232 centers in Germany. All women switched from their previous pill to a combiphasic oral contraceptive containing ethinylestradiol and desogestrel (combiphasic EE/DSG; comprising 25 μg desogestrel and 40 μg ethinylestradiol for 7 days followed by 125 μg desogestrel and 30 μg ethinylestradiol for 15 days and then a 6-day pill-free interval) for three cycles. Results Most women (53%) had previously used a monophasic oral contraceptive containing 20 or 30–35 μg ethinylestradiol. The most frequent reasons for switching were bleeding irregularities (41% of women), other menstrual disorders (27%) and migraine/headache (10%). After switching to combiphasic EE/DSG, cycle control improved significantly: the incidences of spotting and breakthrough bleeding decreased from 33% and 23% of women, respectively, before the start of the study, to 7% and 3% of women at the end of the study period. At the end of the study, acne was no longer present in 37% of the 592 women who had acne at the start of the study, and subjective complaints such as headaches were less frequent than before. Most women were satisfied or very satisfied with the combiphasic oral contraceptive and 89% wished to continue using it. Conclusions The results of this observational clinical evaluation indicate that in everyday use, for women who wish to switch from another oral contraceptive, combiphasic EE/DSG is an effective and well-tolerated oral contraceptive, which improves cycle control and has a beneficial effect on acne.