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Fertility and Sterility Nov 2018To assess the efficacy of an etonogestrel (ENG)-releasing contraceptive implant or the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) in the control of... (Randomized Controlled Trial)
Randomized Controlled Trial
Control of endometriosis-associated pain with etonogestrel-releasing contraceptive implant and 52-mg levonorgestrel-releasing intrauterine system: randomized clinical trial.
OBJECTIVE
To assess the efficacy of an etonogestrel (ENG)-releasing contraceptive implant or the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) in the control of endometriosis-associated pelvic pain.
DESIGN
Noninferiority randomized clinical trial in which women with endometriosis were assigned to use an ENG implant (experimental treatment) or an LNG-IUS (active comparator). Monthly follow-up visits were conducted up to 6 months.
SETTING
University teaching hospital.
PATIENT(S)
One hundred three women, with endometriosis-associated chronic pelvic pain, dysmenorrhea, or both for more than 6 months. In cases of deep endometriosis, vaginal ultrasonography and magnetic resonance imaging were used as additional diagnostic tools.
INTERVENTION(S)
The ENG implant or the LNG-IUS were inserted within the first 5 days of the menstrual cycle.
MAIN OUTCOME MEASURE(S)
Daily scores of noncyclic pelvic pain and dysmenorrhea were evaluated using a daily visual analogue scale. Health-related quality of life was evaluated using the Endometriosis Health Profile-30 questionnaire at baseline and up to 6 months. Bleeding patterns were assessed daily from a menstrual calendar.
RESULT(S)
Both contraceptives improved significantly the mean visual analogue scale endometriosis-associated pelvic pain and dysmenorrhea, without significant differences between treatment group profiles. Health-related quality of life improved significantly in all domains of the core and modular segments of the Endometriosis Health Profile-30 questionnaire, with no difference between both treatment groups. The most common bleeding patterns at 180 days of follow-up were amenorrhea and infrequent bleeding and infrequent bleeding and spotting among ENG implant and LNG-IUS users, respectively.
CONCLUSION(S)
In this noninferiority study both contraceptives improved significantly pelvic pain, dysmenorrhea, and health-related quality of life in endometriosis.
CLINICAL TRIAL REGISTRATION NUMBER
Clinicaltrials.gov under number NCT02480647.
Topics: Adult; Contraceptive Agents, Female; Desogestrel; Drug Implants; Drug Liberation; Endometriosis; Female; Follow-Up Studies; Humans; Intrauterine Devices, Medicated; Levonorgestrel; Pain Management; Pelvic Pain
PubMed: 30396557
DOI: 10.1016/j.fertnstert.2018.07.003 -
Journal de Gynecologie, Obstetrique Et... Dec 2016To establish guidelines of the French National College of Gynecologists and Obstetricians about post-abortion contraception. (Review)
Review
OBJECTIVE
To establish guidelines of the French National College of Gynecologists and Obstetricians about post-abortion contraception.
MATERIALS AND METHODS
A systematic review of the literature about post-abortion contraception was performed on Medline and Cochrane Database between 1978 and March 2016. The guidelines of the French and foreign scientific societies were also consulted.
RESULTS AND DISCUSSION
After an abortion, if the woman wishes to use a contraception, it should be started as soon as possible because of the very early ovulation resumption. The contraception choice must be done in accordance with the woman's expectations and lifestyle. The contraindications of each contraception must be respected. The long-acting reversible contraception, intra-uterine device (IUD) and implant, could be preferred (grade C) as the efficacy is not dependent on compliance. Thus, they could better prevent repeat abortion (LE3). In case of surgical abortion, IUD should be proposed and inserted immediately after the procedure (grade A), as well as the implant (grade B). In case of medical abortion, the implant can be inserted from the day of mifépristone, the IUD after an ultrasound examination confirming the success of the abortion (no continuing pregnancy or retained sac) (grade C).
Topics: Abortion, Induced; Contraceptive Agents, Female; Drug Implants; Female; Humans; Intrauterine Devices; Pregnancy
PubMed: 27773547
DOI: 10.1016/j.jgyn.2016.09.017 -
Contraception Dec 2015
Topics: Contraception; Drug Implants; Female; Humans; Intrauterine Devices
PubMed: 26585715
DOI: 10.1016/j.contraception.2015.10.009 -
BMJ Clinical Evidence Aug 2015A woman has premenstrual syndrome (PMS) if she complains of recurrent psychological and/or physical symptoms occurring during the luteal phase of the menstrual cycle,... (Review)
Review
INTRODUCTION
A woman has premenstrual syndrome (PMS) if she complains of recurrent psychological and/or physical symptoms occurring during the luteal phase of the menstrual cycle, and often resolving by the end of menstruation. Symptom severity can vary between women. Premenstrual symptoms occur in 95% of women of reproductive age. Severe, debilitating symptoms occur in about 5% of those women. There is no consensus on how symptom severity should be assessed for PMS, which has led to the use of a wide variety of symptom scores and scales, thus making it difficult to synthesise data on treatment efficacy. The cyclical nature of the condition also makes it difficult to conduct RCTs.
METHODS AND OUTCOMES
We conducted a systematic overview, aiming to answer the following clinical question: What are the effects of continuous hormonal treatments in women with premenstrual syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2014 (Clinical Evidence overviews are updated periodically; please check our website for the most up-to-date version of this overview).
RESULTS
At this update, searching of electronic databases retrieved 132 studies. After deduplication and removal of conference abstracts, 132 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 102 studies and the further review of 30 full publications. Of the 30 full articles evaluated, one systematic review and three RCTs were added to this overview. We performed a GRADE evaluation for three PICO combinations.
CONCLUSIONS
In this systematic overview, we categorised the efficacy for three interventions based on information relating to the effectiveness and safety of continuous combined oral contraceptives, continuous transdermal estradiol, and continuous subcutaneous estradiol implants.
Topics: Administration, Cutaneous; Contraceptives, Oral, Combined; Drug Implants; Estradiol; Female; Humans; Infusions, Subcutaneous; Premenstrual Syndrome
PubMed: 26303988
DOI: No ID Found -
AAPS PharmSciTech Sep 2019Implantable drug delivery systems, such as drug pumps and polymeric drug depots, have emerged as means of providing predetermined drug release profiles at the desired... (Review)
Review
Implantable drug delivery systems, such as drug pumps and polymeric drug depots, have emerged as means of providing predetermined drug release profiles at the desired site of action. While initial implants aimed at providing an enduring drug supply, developments in polymer chemistry and pharmaceutical technology and the growing need for refined drug delivery patterns have prompted the design of sophisticated drug delivery implants such as on-demand drug-eluting implants and personalized 3D printed implants. The types of cargo loaded into these implants range from small drug molecules to hormones and even therapeutic cells. This review will shed light upon recent advances in materials and composites used for polymeric implant fabrication, highlight select approaches employed in polymeric implant fabrication, feature medical applications where polymeric implants have a significant impact, and report recent advances made in these areas.
Topics: Animals; Drug Delivery Systems; Drug Implants; Drug Liberation; Humans; Infusion Pumps, Implantable; Polymers; Printing, Three-Dimensional; Technology, Pharmaceutical
PubMed: 31482251
DOI: 10.1208/s12249-019-1510-0 -
Advanced Drug Delivery Reviews Dec 2020A broad range of medical devices initiate an immune reaction known as the foreign body response (FBR) upon implantation. Here, collagen deposition at the surface of the... (Review)
Review
A broad range of medical devices initiate an immune reaction known as the foreign body response (FBR) upon implantation. Here, collagen deposition at the surface of the implant occurs as a result of the FBR, ultimately leading to fibrous encapsulation and, in many cases, reduced function or failure of the device. Despite significant efforts, the prevention of fibrotic encapsulation has not been realized at this point in time. However, many next-generation medical technologies including cellular therapies, sensors and devices depend on the ability to modulate and control the FBR. For these technologies to become viable, significant advances must be made in understanding the underlying mechanism of this response as well as in the methods modulating this response. In this review, we highlight recent advances in the development of materials and coatings providing a reduced FBR and emphasize key characteristics of high-performing approaches. We also provide a detailed overview of the state-of-the-art in strategies relying on controlled drug release, the surface display of bioactive signals, materials-based approaches, and combinations of these approaches. Finally, we offer perspectives on future directions in this field.
Topics: Animals; Biocompatible Materials; Delayed-Action Preparations; Drug Implants; Fibrosis; Foreign-Body Reaction; Humans; Hydra; Inflammation Mediators; Polymers; Prostheses and Implants; Tissue Scaffolds
PubMed: 32553685
DOI: 10.1016/j.addr.2020.06.008 -
Expert Opinion on Drug Delivery Oct 2022Implantable devices can be designed to release drugs to localized regions of tissue at sustained and reliable rates. Advances in polymer engineering have led to the... (Review)
Review
INTRODUCTION
Implantable devices can be designed to release drugs to localized regions of tissue at sustained and reliable rates. Advances in polymer engineering have led to the design and development of drug-loaded implants with predictable, desirable release profiles. Biodegradable polyesters exhibit chemical, physical, and biological properties suitable for developing implants for pain management, cancer therapy, contraception, antiviral therapy, and other applications.
AREAS COVERED
This article reviews the use of biodegradable polyesters for drug-loaded implants by discussing the properties of commonly used polymers, techniques for implant formulation and manufacturing, mechanisms of drug release, and clinical applications of implants as drug delivery devices.
EXPERT OPINION
Drug delivery implants are unique systems for safe and sustained drug release, providing high bioavailability and low toxicity. Depending on the implant design and tissue site of deployment, implants can offer either localized or systemic drug release. Due to the long history of use of degradable polyesters in medical devices, polyester-based implants represent an important class of controlled release technologies. Further, polyester-based implants are the largest category of drug delivery implants to reach the point of testing in humans or approval for human use.
Topics: Humans; Polyesters; Delayed-Action Preparations; Drug Implants; Drug Liberation; Polymers; Drug Delivery Systems
PubMed: 36197839
DOI: 10.1080/17425247.2022.2131768 -
Post Reproductive Health Dec 2023
Topics: Humans; Estradiol; Follicle Stimulating Hormone; Drug Implants
PubMed: 37997701
DOI: 10.1177/20533691231214870 -
Primary Care Dec 2021Nexplanon is the only contraceptive implant currently available in the United States. It exerts its contraceptive effects primarily by suppressing ovulation. The... (Review)
Review
Nexplanon is the only contraceptive implant currently available in the United States. It exerts its contraceptive effects primarily by suppressing ovulation. The Nexplanon is the most effective method of long-acting reversible contraception. The implant should be removed by the end of the third year of use. Persons will experience a rapid return to fertility once the implant is removed. All health care providers must be trained on Nexplanon before performing insertions or removals of the implant. A Nexplanon can be inserted and/or removed as an office-based procedure. The most common adverse reaction is change in menstrual bleeding patterns.
Topics: Contraceptive Agents, Female; Drug Implants; Female; Health Services; Humans; United States
PubMed: 34752268
DOI: 10.1016/j.pop.2021.07.002 -
Expert Opinion on Drug Delivery Mar 2015Proteins are effective biotherapeutics with applications in diverse ailments. Despite being specific and potent, their full clinical potential has not yet been realized.... (Review)
Review
INTRODUCTION
Proteins are effective biotherapeutics with applications in diverse ailments. Despite being specific and potent, their full clinical potential has not yet been realized. This can be attributed to short half-lives, complex structures, poor in vivo stability, low permeability, frequent parenteral administrations and poor adherence to treatment in chronic diseases. A sustained release system, providing controlled release of proteins, may overcome many of these limitations.
AREAS COVERED
This review focuses on recent development in approaches, especially polymer-based formulations, which can provide therapeutic levels of proteins over extended periods. Advances in particulate, gel-based formulations and novel approaches for extended protein delivery are discussed. Emphasis is placed on dosage form, method of preparation, mechanism of release and stability of biotherapeutics.
EXPERT OPINION
Substantial advancements have been made in the field of extended protein delivery via various polymer-based formulations over last decade despite the unique delivery-related challenges posed by protein biologics. A number of injectable sustained-release formulations have reached market. However, therapeutic application of proteins is still hampered by delivery-related issues. A large number of protein molecules are under clinical trials, and hence, there is an urgent need to develop new methods to deliver these highly potent biologics.
Topics: Biological Products; Chemistry, Pharmaceutical; Delayed-Action Preparations; Drug Delivery Systems; Drug Implants; Drug Liberation; Drug Stability; Gels; Hydrogen-Ion Concentration; Microspheres; Nanoparticles; Peptides; Polymers; Proteins
PubMed: 25251334
DOI: 10.1517/17425247.2015.961420