Investigation of the Hemostatic Effect of a Transdermal Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene Compared with a Monophasic Oral Contraceptive Containing 0.03 mg Ethinyl Estradiol and 0.15 mg Levonorgestrel: An Open-Label, Randomized, Crossover Study

Junge, Wolfgang; Heger-Mahn, Doris; Trummer, Dietmar; Merz, Martin

doi:10.1007/s40268-013-0028-2

Cited by 9 publications

(6 citation statements)

References 26 publications

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“…In 85.7% of participants, ovulation returned in the first cycle following termination of treatment 48. No alterations were observed in prothrombin fragments 1 + 2 or D-dimer when the patch was compared with a COC containing 0.03 mg EE/0.15 mg LNG 49. An application has been made to the European authorities; however, there is no information on whether an application has been made in the US.…”

Section: New Contraceptive Methods Recently Launched In Different Marmentioning

confidence: 99%

New and emerging contraceptives: a state-of-the-art review

Bahamondes¹,

Bahamondes²

2014

IJWH

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BackgroundThe first hormonal contraceptive was introduced onto the market in several countries 50 years ago; however, the portfolio of contraceptive methods remains restricted with regards to their steroid composition, their cost, and their ability to satisfy the requirements of millions of women/couples in accordance with their different reproductive intentions, behaviors, cultures, and settings.MethodsA literature review was conducted using Medline, Embase, and Current Contents databases, up to September 1, 2013 to identify publications reporting new contraceptives in development using combinations of the search terms: contraception, contraceptives, oral contraceptives, patch, vaginal ring, implants, intrauterine contraceptives, and emergency contraception (EC). Also, several experts in the field were also consulted to document ongoing projects on contraception development. Additionally, the Clinicaltrial.gov website was searched for ongoing studies on existing contraceptive methods and new and emerging female contraceptives developed over the past 5 years. Information was also obtained from the pharmaceutical industry.ResultsEarly sexual debut and late menopause means that women may require contraception for up to 30 years. Although oral, injectable, vaginal, transdermal, subdermal, and intrauterine contraceptives are already available, new contraceptives have been developed in an attempt to reduce side effects and avoid early discontinuation, and to fulfill women’s different requirements. Research efforts are focused on replacing ethinyl-estradiol with natural estradiol to reduce thrombotic events. In addition, new, less androgenic progestins are being introduced and selective progesterone receptor modulators and new delivery systems are being used. In addition, research is being conducted into methods that offer dual protection (contraception and protection against human immunodeficiency virus transmission), and contraceptives for use “on demand.” Studies are also investigating non-hormonal contraceptive methods that have additional, non-contraceptive benefits.ConclusionThe most pressing need worldwide is, first, that the highly effective contraceptive methods already available should be affordable to most of the population and also that these methods should fulfill the needs of women of different ages and with different reproductive requirements. The development of new contraceptive methods should also take advantage of the knowledge obtained over the past 30 years on gamete physiology and gamete interaction to avoid the use of steroid compounds.

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Section: New Contraceptive Methods Recently Launched In Different Marmentioning

confidence: 99%

New and emerging contraceptives: a state-of-the-art review

Bahamondes¹,

Bahamondes²

2014

IJWH

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“…In a recent study by Junge et al, 28 surrogate parameters for risk of venous thromboembolism were examined for a patch containing 0.55 mg of ethinylestradiol and 2.1 mg of gestodene. This was compared with an oral contraceptive pill containing 0.03 mg of ethinylestradiol and 0.15 mg of levonorgestrel.…”

Section: New Patch Containing Ethinylestradiol and Gestodenementioning

confidence: 99%

“…Compliance in both groups was excellent. 28 Another pharmacological system, ie, a double-layer matrix releasing gestodene and ethinylestradiol steadily over one week, was introduced in 2009. 29 Overall, transdermal contraception can be offered as a safe, efficient, and convenient method of contraception.…”

Section: New Patch Containing Ethinylestradiol and Gestodenementioning

confidence: 99%

New and emerging contraceptive options: a focus on transdermal contraception

Böttcher¹,

Wildt²

2014

OAJC

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Transdermal contraception is a convenient way of hormonal contraception that allows weekly application of a patch for 3 consecutive weeks followed by a patch-free week. Efficacy, side effects, advantages, and disadvantages as well as patient satisfaction with this formulation are discussed in this short review. The first patch, introduced in 2002, contained ethinylestradiol and norelgestromin. Recently, a new patch containing gestodene as the gestagen component has been developed. Early data for this formulation are presented.

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“…[19][20][21] Finally, gonadal hormones are known to affect coagulation. [22][23][24] However, little of this has been evaluated after ICH. The first steps are (1) characterize gonadal hormone physiology after ICH and (2) define associations between hormone concentrations, pathophysiology, and recovery.…”

mentioning

confidence: 99%

Gonadal hormone regulation as therapeutic strategy after acute intracerebral hemorrhage

James

Christianson

Woo

et al. 2017

Proceedings of Singapore Healthcare

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Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons AttributionNonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).Intracerebral hemorrhage (ICH) constitutes ~15% of strokes subtypes in the United States (US) and results in greater morbidity and mortality than ischemic stroke. 1-3 Despite priority reports by the National Institutes of Health and American Heart Association, 4,5 ICH remains the only stroke subtype without proven effective therapy. To date, ICH clinical trials have largely focused on hematoma reduction. Despite hematoma volume, robust secondary injury occurs through neuroinflammation, which manifests as cerebral edema after ICH. Prior reports have shown cerebral edema formation 6-8 and systemic inflammation 9-13 after ICH to be robust and inversely associated with neurological outcome. Strategies that target inflammation in the brain and body may carry high potential for improving ICH outcome. Based on preclinical work, one promising neurotherapeutic strategy may be gonadal hormone regulation. Despite this, results of prior clinical trials for progesterone in acute traumatic brain injury (TBI) and estrogen for ischemic stroke failed to show efficacy. However, treatment benefit in these trials may have been negated by (1) enrolling individuals with normal hormonal production or on oral replacement therapy and (2) lack of data on baseline levels or failure to understand hormonal physiology after the neurologic injury. Thus, effects of endogenous hormones on outcomes after ICH remain to be defined before embarking on an ICH clinical trial.The exact mechanisms underlying relationships between gonadal hormones, brain injury-associated stress response, neurological outcome, and mortality have not been wholly described. Data are needed on the impact of age, sex, and ethnicity on gonadal hormones in human ICH recovery. Brain recovery mechanisms are clearly tied to gonadal hormones physiology. For example, pleiotropic effects of gonadal hormones improve neurological recovery in up to 50% in preclinical central nervous system (CNS) injury studies. 14-17 Serum estradiol levels in humans are a robust marker of mortality both in men and women with TBI and subarachnoid hemorrhage, and the relationship changes with age. 18 Of course, age and ethnicity influence gonadal hormone regulation. [19][20][21] Finally, gonadal hormones are known to affect coagulation. [22][23][24] However, little of this has been evaluated after ICH. The first steps are (1) characterize gonadal hormone physiology after ICH and (2) define associations between hormone concentrations, pathophysiology, and recovery. These associations will lay the framework for defining if/how these hormones might contribute to neurop...

show abstract

Investigation of the Hemostatic Effect of a Transdermal Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene Compared with a Monophasic Oral Contraceptive Containing 0.03 mg Ethinyl Estradiol and 0.15 mg Levonorgestrel: An Open-Label, Randomized, Crossover Study

Cited by 9 publications

References 26 publications

New and emerging contraceptives: a state-of-the-art review

New and emerging contraceptives: a state-of-the-art review

New and emerging contraceptive options: a focus on transdermal contraception

Gonadal hormone regulation as therapeutic strategy after acute intracerebral hemorrhage

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