Ovulation inhibition with four variations of a four-phasic estradiol valerate/dienogest combined oral contraceptive : results of two prospective, randomized, open-label studies

Background: Attempts to improve the tolerability of combined oral contraceptives (COCs) have included the substitution of ethinylestradiol (EE) with 17beta-estradiol (E2). However, this has proved unsatisfactory, specifically in terms of cycle control. To improve upon the poor cycle control seen previously, E2 (in the form of estradiol valerate [E2V], 1 mg E2V contains 0.76 mg E2) was combined with dienogest (DNG) in a novel four-phasic regimen. In the current studies the ovulation inhibition potency of four variations of this regimen was assessed. Study design: Two randomized, open-label, phase II studies were performed. The first study compared two regimens (1A, 2A) with similar dosages of DNG but different lengths of application. Having established in Study 1 that the length of application of regimen 2A was most suitable but that the dosages of DNG were too low for effective ovulation inhibition, a second study was undertaken, which compared two regimens (2B, 2C) with similar lengths of application but increased dosages of DNG. The primary efficacy variable in both studies was the proportion of women with a Hoogland score of 5/6 during Cycle 2. Results: The full analysis set comprised 192 and 203 women in Study 1 and 2, respectively. In Study 1, 10 women (10.9%) in regimen 1A and 6 women (6.4%) in regimen 2A had a Hoogland score of 5/6. In Study 2, 3 women (3.1 %) in regimen 2B and 1 woman (1.0%) in regimen 2C had a Hoogland score of 5/6. There were no safety concerns with any of the regimens

Ovulation inhibition with four variations of a four-phasic estradiol valerate/dienogest combined oral contraceptive : results of two prospective, randomized, open-label studies

Background: Attempts to improve the tolerability of combined oral contraceptives (COCs) have included the substitution of ethinylestradiol (EE) with 17beta-estradiol (E2). However, this has proved unsatisfactory, specifically in terms of cycle control. To improve upon the poor cycle control seen previously, E2 (in the form of estradiol valerate [E2V], 1 mg E2V contains 0.76 mg E2) was combined with dienogest (DNG) in a novel four-phasic regimen. In the current studies the ovulation inhibition potency of four variations of this regimen was assessed. Study design: Two randomized, open-label, phase II studies were performed. The first study compared two regimens (1A, 2A) with similar dosages of DNG but different lengths of application. Having established in Study 1 that the length of application of regimen 2A was most suitable but that the dosages of DNG were too low for effective ovulation inhibition, a second study was undertaken, which compared two regimens (2B, 2C) with similar lengths of application but increased dosages of DNG. The primary efficacy variable in both studies was the proportion of women with a Hoogland score of 5/6 during Cycle 2. Results: The full analysis set comprised 192 and 203 women in Study 1 and 2, respectively. In Study 1, 10 women (10.9%) in regimen 1A and 6 women (6.4%) in regimen 2A had a Hoogland score of 5/6. In Study 2, 3 women (3.1 %) in regimen 2B and 1 woman (1.0%) in regimen 2C had a Hoogland score of 5/6. There were no safety concerns with any of the regimens

Hormonal contraceptive use lowers female intrasexual competition in pair-bonded women

<p>The purpose of this study was to test the influence of hormonal contraceptive use on levels of female intrasexual competition. Twenty-eight women completed a scale for intrasexual competition on three occasions: when using hormonal contraceptives and when regularly cycling at a fertile and a non-fertile cycle stage. When using hormonal contraception, pair-bonded, but not single women, reported significantly lower levels of intrasexual competition than when regularly cycling at either fertile or non-fertile cycle stages. This effect remained significant when controlling for age, length of relationship and relationship satisfaction. Neither pair-bonded nor single women reported shifts in intrasexual competition across the menstrual cycle when fertile as compared to non-fertile. This study benefited from a within-subjects design and a more rigorous assessment of fertility status (transvaginal ultrasonography) than which is typical in the field. Results are discussed in consideration of the evolutionary literature on the stability of romantic relationships and fitness advantages associated with intrasexual competition. Crown Copyright (C) 2013 Published by Elsevier Inc. All rights reserved.</p>

Men perceive their female partners, and themselves, as more attractive around ovulation

The purpose of this study was to test whether men perceive changes in their female partner's attractiveness as a function of her fertility status. We further tested how both male and female self-perception varies in relation to female fertility status. This study benefits from the use of transvaginal ultrasonography to detect fertility during the regular cycle and the use of a within-subjects design in which romantic couples were followed both across the cycle and during hormonal contraceptive use. We find that men rated their female partner as more attractive near to ovulation (when fertile) as compared to during the luteal cycle phase or during hormonal contraceptive use. Moreover, our results point to a presently unrecognized negative consequence of hormonal contraceptive use on male self-perception, with men rating themselves lower in attractiveness when their partner was using hormonal contraceptives than when she was regularly cycling. In contrast, there was no difference across measures in female self-reported attractiveness. Results are discussed in terms of their potential impact on within-couple social dynamics. © 2013 Elsevier B.V

Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters

Objective: To assess the effect on hemostasis parameters of a new combined oral contraceptive (COC). Study design: In this randomized, single centre, open-label, exploratory study, healthy women received either 15 mg estetrol/3 mg drospirenone (E4/DRSP) (n = 39), 30 mcg ethinylestradiol/150 mcg levonorgestrel (EE/LNG) (n = 30), or 20 mcg ethinylestradiol/3 mg drospirenone (EE/DRSP) (n = 32) for six 28day cycles. Blood was collected at baseline, cycle 3, and cycle 6. Median change from baseline was evaluated for procoagulant, anticoagulant, and fibrinolytic parameters, and for sex hormone-binding globulin (SHBG).Results: Median change of endogenous thrombin potential (ETP) based activated protein C sensitivity resistance (APCr) at cycle 6 was +30% for E4/DRSP, +165% for EE/LNG (p-value &lt;0.05 vs E4/DRSP), and +219% for EE/DRSP (p-value &lt;0.05 vs E4/DRSP). Changes to prothrombin fragment 1 + 2 and SHBG for E4/DRSP, EE/LNG, and EE/DRSP were +23%, +71%, and +64% (p-value &lt;0.05 vs E4/DRSP); and +55%, +74% and +251% (p-value &lt;0.05 vs E4/DRSP), respectively. At cycle 6, changes to other hemostasis parameters for E4/DRSP were similar or smaller than for EE/LNG or EE/DRSP.Conclusions: In this study, changes in hemostasis parameters after treatment with 6 cycles of E4/DRSP were smaller or similar to those observed for EE/LNG. Similar, but more pronounced changes were also observed versus EE/DRSP, which supports the hypothesis that the effect of COCs on hemostasis parameters is mainly mediated by the estrogenic component. Further studies are needed to provide more insight into the venous thromboembolic risk of E4/DRSP.Implications statement: This study reports that the effects on hemostasis parameters of a COC containing 15 mg E4/3 mg DRSP are less or similar to those for EE/LNG or EE/DRSP. It also demonstrates that the choice of estrogen modulates the effects of COCs on hemostasis parameters. (C) 2020 Elsevier Inc. All rights reserved

Reported jealousy differs as a function of menstrual cycle stage and contraceptive pill use: a within-subjects investigation

Previous research suggests that female jealousy is sensitive to hormonal variation and, more specifically, potentially moderated by estrogen levels. Here, we tracked self-reported jealousy using a within-subjects design, comparing jealousy when the same women were regularly cycling and using hormonal contraceptives. Results show that fertile cycle phases are associated with higher levels of jealousy than nonfertile cycle phases in both single and partnered women. However, patterns of jealousy reported when using hormonal contraceptives, as compared to when regularly cycling, differed between single and partnered women. In single women, levels of jealousy while on the pill fell between those reported when fertile and nonfertile but were not significantly different from either. In partnered women, levels of jealousy while using the pill were significantly higher than those reported during the nonfertile cycle phase and similar to those during the brief period of fertility. We discuss possible reasons for differences between single and partnered women in reported jealousy while using the pill. This research is the first to definitively show that a psychological characteristic, for example, jealousy, may be influenced differentially by endogenous hormones vs. exogenous hormones administered via hormonal contraceptives