Multicenter, Open-label, Uncontrolled Study to Investigate Suppression of Ovarian Activity of a Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in 80 Young Female Volunteers Over 3 Treatment Cycles

The purpose of this study is to look into the effectiveness of a new investigational medication applied as a transdermal patch. The patch is applied on the skin with study medication that is absorbed through the skin suppressing ovarian activity and therefore preventing an egg from leaving an ovary (ovulation). The study will look into the study drug's safety and how well it is tolerated and its absorption, breakdown and elimination in the body. It describes how the body affects a specific drug after administration.

开始日期2015-09-18

申办/合作机构

Bayer AG

NCT00920985 / Completed临床3期

Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 µg Ethinylestradiol and 100 µg Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women

Birth Control Patch Study

开始日期2009-06-01

申办/合作机构

Bayer AG

100 项与孕二烯酮相关的临床结果

登录后查看更多信息

100 项与孕二烯酮相关的转化医学

登录后查看更多信息

100 项与孕二烯酮相关的专利（医药）

登录后查看更多信息

734

项与孕二烯酮相关的文献（医药）

2024-06-01·European Journal of Obstetrics & Gynecology and Reproductive Biology: X

Association between the use of oral contraceptives and the occurrence of systemic hypertension: A systematic review with statistical comparison between randomized clinical trial interventions

Review

作者: de Souza, Ingrid Soares ; Sorpreso, Isabel Cristina Esposito ; Silva Dos Santos, Heloisa Carla Lopes ; Laporta, Gabriel Zorello ; Soares Júnior, José Maria ; Zangirolami-Raimundo, Juliana ; Raimundo, Rodrigo Daminello

IntroductionIn the WHO eligibility criteria, there is agreement that hypertensive women taking Oral Contraceptive Hormonal Combined (OCHC) may be at increased risk of cardiovascular disease. The risk-to-benefit ratio hinges on the severity of the condition. While a mild increase in blood pressure is a common occurrence in consumers of OCHC, the potential for developing high blood pressure exists during oral contraceptive use. Consequently, there is a possibility of increased cardiovascular risk, with limited available data on this issue.ObjectiveTo evaluate the potential effects of OCHC on blood pressure through a systematic review with statistical analysis of existing randomized controlled trials.MethodThis systematic review with statistical comparison adheres to the recommendations outlined in the PRISMA (Principal Reporting Items for Systematic Reviews and Meta-analyses) guidelines. The analysis strategy involves comparing the mean difference in blood pressure change according to the type of treatment, in addition to the calculation of clinically relevant outcomes (CRO).ResultsOur findings suggest a clinically relevant outcome related to the increase in blood pressure in users of ethinyl estradiol combined with gestodene in a cyclic regimen over 6 months. Conversely, a decrease in blood pressure was observed among users of ethinyl estradiol combined with chlormadinone over 24 months of usage.ConclusionWhile our study found minor variations in blood pressure across varying forms of oral contraceptives, these differences are not significant enough to warrant specific clinical recommendations. However, the results suggest that individuals with hypertension should exercise caution with ethinyl estradiol, particularly when administered cyclically alongside gestodene, due to the potential risk of increased blood pressure. Additionally, the use of oral contraceptives containing ethinyl estradiol paired with chlormadinone acetate or ethinyl estradiol combined with drospirenone may be more suitable for individuals at a high risk of developing hypertension.

2024-05-01·Chemosphere

Chronic exposure to gestodene impairs reproductive system in adult female zebrafish (Dania rerio)

Article

作者: Hou, LiPing ; Ye, MeiXin ; Zou, Hong ; Yu, HongJun ; Huang, YunYi ; Guo, YanFang

Gestodene (GES) is widely used in human therapy and animal husbandry and is frequently detected in aquatic environments. Although GES adversely affects aquatic organisms at trace levels, its effects on the reproductive biology of fish remain inconclusive. In this study, female zebrafish (Danio rerio) were exposed to environmentally relevant levels of GES for the evaluation of the effects of GES on the reproductive system by using endpoints including gene expression, plasma steroid concentrations, histological and morphological analyses, copulatory behavior, and reproductive output. Adult female zebrafish exposed to environmentally relevant concentrations of GES (4.0, 40.2, and 372.7 ng/L) for 60 d demonstrated stagnant ovarian oocyte development, evidenced by an increase in the percentage of perinuclear and atretic oocytes and a decrease in the percentage of late vitellogenic oocytes. GES-exposed females were less attractive to males and had lower copulatory intimacy than females in control. Consequently, spawning (44.3-49.2 %) and egg fertilization rates (27.9-32.0 %) were decreased. The decreased survival of fertilized eggs and hatching rates were accompanied by increased malformations. These negative effects were associated with abnormal transcriptional levels of gonadal steroid hormones, which were regulated by genes (Hsd17β3, Hsd11β2, Hsd20β, Cyp19a1a, and Cyp11b). Overall, our findings suggest that GES impairs the reproductive system of zebrafish, which may threaten population stability.

2024-04-02·Revista Brasileira de Ginecologia e Obstetrícia / RBGO Gynecology and Obstetrics

Use of hormones and risk of venous thromboembolism

Article

作者: de Oliveira, André Luiz Malavasi Longo ; de Barros, Venina Isabel Poço Viana Leme ; do Nascimento, Denis Jose ; Marques, Marcos Arêas ; Zlotnik, Eduardo ; Margarido, Paulo Francisco Ramos ; Teruchkin, Marcelo Melzer

•The risk of venous thromboembolism (VTE) is not increased in women using long-acting reversible contraceptive methods (LARCs) with progestogens. •Oral contraceptives with levonorgestrel or norgestimate confer half the risk of VTE compared to oral contraceptives containing desogestrel, gestodene or drospirenone. •Progestogen-only pills do not confer an increased risk of VTE. •Women using transdermal contraceptive patches and combined oral contraceptives (COCs) are at an approximately eight times greater risk of VTE than non-users of hormonal contraceptives (HCs), corresponding to 9.7 events per 10,000 women/years. •Vaginal rings increase the risk of VTE by 6.5 times compared to not using HC, corresponding to 7.8 events per 10,000 women/years. •Several studies have demonstrated an increased risk of VTE in transgender individuals receiving hormone therapy (HT). •Hormone therapy during menopause increases the risk of VTE by approximately two times, and this risk is increased by obesity, thrombophilia, age over 60 years, surgery and immobilization. •The route of estrogen administration, the dosage and type of progestogen associated with estrogen may affect the risk of VTE in the climacteric. •Combined estrogen-progesterone therapy increases the risk of VTE compared to estrogen monotherapy. •Postmenopausal HT increases the risk of thrombosis at atypical sites.

100 项与孕二烯酮相关的药物交易

登录后查看更多信息