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

Huber, J.F.K.; Foidart, Jean‐Michel; Wuttke, W.; Merki‐Feld, Gabriele S.; Gerlinger, Christoph; Schellschmidt, Ilka; Heithecker, R.

doi:10.1080/13625180008500375

Cited by 119 publications

(54 citation statements)

References 8 publications

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“…Compared to baseline, the mean body weight during treatment with the DRSP combination was slightly decreased in most cycles, while it was slightly increased vs. baseline in all cycles during treatment with the DSG combination. The combination with DRSP had less impact on blood pressure than the combination with DSG confirming the findings of previous publications [14,16]. The favorable influence of the combination with DRSP on body weight and blood pressure is presumably due to the antimineralocorticoid effect of DRSP.…”

Section: Discussionsupporting

confidence: 89%

“…In accordance with the findings of other groups, both preparations were well tolerated and equally efficacious in terms of contraception and cycle control [14,15]. Compared to baseline, the mean body weight during treatment with the DRSP combination was slightly decreased in most cycles, while it was slightly increased vs. baseline in all cycles during treatment with the DSG combination.…”

Section: Discussionsupporting

confidence: 87%

“…In this respect, the novel progestin drospirenone (DRSP), a 17-α-spirolactone derivative, is particularly interesting because of its unique pharmacological profile with antiandrogenic and antimineralocorticoid activity in addition to its potent progestogenic activity [11][12][13]. The antimineralocorticoid activity, which has not yet been described for any other synthetic progestin, may reduce possible water retention in women using OCs [14].…”

Section: Introductionmentioning

confidence: 99%

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A randomized study over 13 cycles to assess the influence of oral contraceptives containing ethinylestradiol combined with drospirenone or desogestrel on carbohydrate metabolism

Gaspard¹,

Scheen²,

Endrikat³

et al. 2003

Contraception

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In this open-label, randomized study we compared the influence of a new oral contraceptive containing 30 µg ethinylestradiol and 3 mg drospirenone (Yasmin™) with a reference preparation containing 30 µg ethinylestradiol and 150 µg desogestrel (Marvelon™) on variables of carbohydrate metabolism by means of oral glucose tolerance tests at baseline and in the 6th and 13th treatment cycle. The mean levels of fasting glucose and insulin were similar at baseline and after 13 treatment cycles, whereas C-peptide and free fatty acid levels decreased slightly in both groups. All blood glucose and insulin values measured in the oral glucose tolerance tests were within normal ranges, despite a slight increase in the mean areas under the curves of 0-3 h [AUCs (0-3 h)] of both variables from baseline to treatment cycle 13. Differences between both treatments were not statistically significant. The mean AUCs (0-3 h) for C-peptide were not markedly changed in any treatment group. Free fatty acid levels decreased by 42% in the drospirenone group and increased by 48.9% in the desogestrel group, in terms of means of individual changes. Both preparations were well tolerated and equally efficacious regarding contraception and cycle control. The mean body weight was slightly decreased in most cycles during treatment with the drospirenone combination, as compared to baseline, while it was slightly increased versus baseline in all cycles during treatment with the desogestrel combination. The combination with drospirenone had less impact on blood pressure than the combination with desogestrel. In conclusion, Yasmin, a combined low-dose oral contraceptive with 30 µg ethinylestradiol and 3 mg of the novel progestogen drospirenone, as well as the reference Marvelon, containing 30 µg ethinylestradiol and 150 µg desogestrel had little impact on carbohydrate metabolism when used for 1 year. The observed changes were small and not suggestive of a clinically relevant deterioration of carbohydrate metabolism.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

A randomized study over 13 cycles to assess the influence of oral contraceptives containing ethinylestradiol combined with drospirenone or desogestrel on carbohydrate metabolism

Gaspard¹,

Scheen²,

Endrikat³

et al. 2003

Contraception

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“…The potential benefits offered by this improved pharmacological profile of DRSP have translated into a positive effect on body weight in clinical trials of an oral contraceptive containing DRSP and EE [62][63][64] (see Table 3). Data from two large, randomised, comparative trials show that mean body weight remained significantly lower in women receiving the oral contraceptive EE 30 µg/DRSP 3 mg than in women receiving EE 30 µg/desogestrel 150 µg over 13 or 26 cycles [63,64]. Similar findings have been shown when E2/DRSP is used as HRT in post-menopausal women [43].…”

Section: The Effect Of Drsp On Body Weightmentioning

confidence: 99%

Advances in hormone replacement therapy with drospirenone, a unique progestogen with aldosterone receptor antagonism

2006

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Unlike other currently available progestogens, drospirenone (DRSP) has a pharmacological profile, which closely mimics that of endogenous progesterone, most notably potent anti-aldosterone and anti-androgenic effects. Consequently, DRSP, when combined with 17β-estradiol (E2) as hormone replacement therapy (HRT), offsets E2-related water and sodium retention by blocking the mineralocorticoid receptor. This review evaluates the potential benefits offered by DRSP as the progestin component of HRT with respect to its anti-aldosterone activity, which translates into positive effects on body weight and blood pressure in clinical trials of continuous, combined E2/DRSP in post-menopausal women. In a 1 -year, large-scale, randomised, controlled trial, E2 1 mg/DRSP 2 mg significantly decreased mean body weight by 1.2 kg versus baseline (P < 0.001), whereas patients receiving E2 1 mg gained weight. E2 1 mg/DRSP 2 mg also significantly lowered mean systolic blood pressure (SBP) by 9.0 mmHg from baseline (P < 0.05) versus 3.7 mmHg in the E2 1 mg group (P = 0.220) in a sub-group of hypertensive women. In addition, E2/DRSP was not associated with hyperkalemia (potassium ≥ 5.5 meq/L) irrespective of concomitant use of ACE inhibitors, angiotensin II receptor antagonists or non-steroidal anti-inflammatory drugs, and co-morbid diabetes mellitus. In summary, as well as effectively treating climacteric symptoms, DRSP 2 mg combined with E2 1 mg has shown positive effects on body weight and blood pressure in clinical trials, most likely due to DRSP's anti-aldosterone properties. This combination may therefore offer an alternative therapeutic option with additional benefits beyond current HRT agents for symptomatic postmenopausal women.

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“…The 126-day extended regimen consists of a known combination of 30 µg ethinylestradiol (EE) and 3 mg drospirenone (DRSP) (Yasmin®, Schering) at a dose level of proven efficacy and safety [13,14]. Because this formulation has been shown to reduce water retention, weight gain, premenstrual symptoms and skin disorders such as acne when used in a 21+7-day fashion, it was chosen as a possible ideal candidate for an extended cycle regimen [15][16][17].…”

Section: Introductionmentioning

confidence: 99%

The use of an oral contraceptive containing ethinylestradiol and drospirenone in an extended regimen over 126 days

Foidart¹,

Sulak

Schellschmidt³

et al. 2006

Contraception

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Objective: To assess the bleeding profile, acceptance and safety of an extended 126-day regimen of the oral contraceptive Yasmin® [30 µg ethinylestradiol (EE) and 3 mg drospirenone (DRSP)]. Methods: Using daily diaries, 177 women recorded bleeding events throughout the 126-day cycle. At end of treatment, the women completed questionnaires reflecting their satisfaction with the extended regimen. A subset of 30 women underwent endometrial histology sampling after completion of the extended regimen. Results: Of 177 women assigned to the extended regimen, 80.8% completed the extended 126-day regimen. Approximately 40% of the women reported complete absence of bleeding, while in 60% a shift towards less intense bleeding was observed. The first onset of bleeding occurred after a median of 99.0 days into the extended cycle. The acceptance of the extended regimen was high, with 68.4% of the women expressing satisfaction. The general safety profile with the extended use was comparable to that seen with the conventional 21+7-day regimen. All endometrial biopsies with sufficient material for analysis were normal and supported the endometrial safety of the extended regimen. Conclusion: This study showed that the continuous use of a 30-µg EE and 3-mg DRSP formulation over 126 days was safe, efficacious, well

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

Cited by 119 publications

References 8 publications

A randomized study over 13 cycles to assess the influence of oral contraceptives containing ethinylestradiol combined with drospirenone or desogestrel on carbohydrate metabolism

A randomized study over 13 cycles to assess the influence of oral contraceptives containing ethinylestradiol combined with drospirenone or desogestrel on carbohydrate metabolism

Advances in hormone replacement therapy with drospirenone, a unique progestogen with aldosterone receptor antagonism

The use of an oral contraceptive containing ethinylestradiol and drospirenone in an extended regimen over 126 days

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