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International Journal of Sports... Aug 2018To identify the period prevalence of hormonal contraceptive (HC) use and characterize the perceived side effects associated with the menstrual cycle and HC use.
PURPOSE
To identify the period prevalence of hormonal contraceptive (HC) use and characterize the perceived side effects associated with the menstrual cycle and HC use.
METHODS
A total of 430 elite female athletes completed a questionnaire to assess the period prevalence of HC use, the reasons for initiation and discontinuation of HCs, and the side effects experienced by HC and non-HC users. Descriptive statistics, between-groups comparisons, and associations between categorical variables were calculated.
RESULTS
Of athletes studied, 49.5% were currently using HCs and 69.8% had used HCs at some point. Combined oral contraceptives were most commonly used (68.1%), with 30.0% using progestin-only contraceptives (implant = 13.1%, injection = 3.7%, and intrauterine system = 2.8%). Perceived negative side effects were more common with progestin-only HC use (39.1%) compared with combined-HC use (17.8%; P = .001) and were most prevalent in implant users (53.6%; P = .004). HC users reported perceived positive side effects relating to their ability to predict and/or manipulate the timing, frequency, and amount of menstrual bleeding. Non-HC users had a menstrual cycle length of 29 (5) d and 77.4% reported negative side effects during their menstrual cycle, primarily during days 1-2 of menstruation (81.6%).
CONCLUSIONS
Approximately half of elite athletes used HCs, and progestin-only contraceptive users reported greater incidences of negative side effects, especially with the implant. Because of the high interindividual variability in reported side effects, athletes and practitioners should maintain an open dialogue to pursue the best interests of the athlete.
Topics: Adult; Athletes; Contraceptives, Oral, Combined; Contraceptives, Oral, Hormonal; Drug Implants; Emotions; Female; Humans; Injections; Intrauterine Devices, Medicated; Menstrual Cycle; Menstruation Disturbances; Perception; Progestins; Surveys and Questionnaires; Young Adult
PubMed: 29283683
DOI: 10.1123/ijspp.2017-0330 -
Ophthalmology Oct 2014To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME).
DESIGN
Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis.
PARTICIPANTS
Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of ≥300 μm by optical coherence tomography.
METHODS
Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at ≤40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months.
MAIN OUTCOME MEASURES
The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of ≥15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP).
RESULTS
Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. The percentage of patients with ≥15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P ≤ 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (-111.6 μm) and DEX implant 0.35 mg (-107.9 μm) than sham (-41.9 μm; P < 0.001). Rates of cataract-related adverse events in phakic eyes were 67.9%, 64.1%, and 20.4% in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively. Increases in IOP were usually controlled with medication or no therapy; only 2 patients (0.6%) in the DEX implant 0.7 mg group and 1 (0.3%) in the DEX implant 0.35 mg group required trabeculectomy.
CONCLUSIONS
The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. The safety profile was acceptable and consistent with previous reports.
Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Area Under Curve; Dexamethasone; Diabetic Retinopathy; Drug Implants; Female; Humans; Intravitreal Injections; Macular Edema; Male; Middle Aged; Visual Acuity
PubMed: 24907062
DOI: 10.1016/j.ophtha.2014.04.024 -
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 -
Therapeutic Delivery Feb 2020
Topics: Angiogenesis Inhibitors; Drug Implants; Intravitreal Injections
PubMed: 31914868
DOI: 10.4155/tde-2019-0081 -
Dermatology Online Journal May 2018The role of exogenous progestin in the development of acne is unclear. Progestins are known for their androgenic potential, but newer generations of progestins have low... (Review)
Review
The role of exogenous progestin in the development of acne is unclear. Progestins are known for their androgenic potential, but newer generations of progestins have low or anti-androgenic activity. This review will evaluate the association between progestins found in hormonal long-acting reversible contraceptives (intrauterine devices and subdermal implants) and acne, as well as the role of oral contraceptives in acne management. Our review demonstrates that the cause and effect relationship between progestins and acne is difficult to establish and future studies that seek to understand how progestins modulate acne are necessary.
Topics: Acne Vulgaris; Androgens; Contraceptives, Oral; Drug Implants; Humans; Intrauterine Devices, Medicated; Progestins
PubMed: 30142728
DOI: No ID Found -
European Journal of Pharmaceutics and... Feb 2021In the field of drug delivery, the most commonly used treatments have traditionally been systemically delivered using oral or intravenous administration. The problems... (Review)
Review
In the field of drug delivery, the most commonly used treatments have traditionally been systemically delivered using oral or intravenous administration. The problems associated with this type of delivery is that the drug concentration is controlled by first pass metabolism, and therefore may not always remain within the therapeutic window. Implantable drug delivery systems (IDDSs) are an excellent alternative to traditional delivery because they offer the ability to precisely control the drug release, deliver drugs locally to the target tissue, and avoid the toxic side effects often experienced with systemic administration. Since the creation of the first FDA-approved IDDS in 1990, there has been a surge in research devoted to fabricating and testing novel IDDS formulations. The versatility of these systems is evident when looking at the various biomedical applications that utilize IDDSs. This review provides an overview of the history of IDDSs, with examples of the different types of IDDS formulations, as well as looking at current and future biomedical applications for such systems. Though there are still obstacles that need to be overcome, ever-emerging new technologies are making the manufacturing of IDDSs a rewarding therapeutic endeavor with potential for further improvements.
Topics: Delayed-Action Preparations; Drug Approval; Drug Compounding; Drug Implants; Drug-Eluting Stents; History, 20th Century; History, 21st Century; Humans; United States; United States Food and Drug Administration
PubMed: 33338604
DOI: 10.1016/j.ejpb.2020.12.005 -
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 -
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 -
Women's Health (London, England) Aug 2015Progestins are synthetic compounds that mimic the effects of progesteron. For over 50 years, oral progestins have been demonstrated to be effective in the treatment of... (Review)
Review
Progestins are synthetic compounds that mimic the effects of progesteron. For over 50 years, oral progestins have been demonstrated to be effective in the treatment of endometriosis. They were reported to reduce or eliminate pain symptoms in approximately 90% of the patients. Progestins are available in many forms, including oral preparations, injections, subdermal implants and intrauterine systems. Continuous progestin use is an effective therapy for the treatment of painful symptoms associated with endometriosis but there had been no evidence of progestin use being superior to other types of treatment in endometriosis-related pain symptoms.
Topics: Drug Implants; Endometriosis; Endometrium; Female; Humans; Intrauterine Devices, Medicated; Pelvic Pain; Progestins
PubMed: 26389558
DOI: 10.2217/whe.15.42 -
Best Practice & Research. Clinical... Aug 2014Progestin-only contraceptive injectables and implants are highly effective, longer-acting contraceptive methods that can be used by most women in most circumstances.... (Review)
Review
Progestin-only contraceptive injectables and implants are highly effective, longer-acting contraceptive methods that can be used by most women in most circumstances. Globally, 6% of women using modern contraception use injectables and 1% use implants. Injectables are the predominant contraceptive method used in sub-Saharan Africa, and account for 43% of modern contraceptive methods used. A lower-dose, subcutaneous formulation of the most widely used injectable, depot-medroxyprogesterone acetate, has been developed. Implants have the highest effectiveness of any contraceptive method. Commodity cost, which historically limited implant availability in low-resource countries, was markedly lowered between 2012 and 2013. Changes in menstrual bleeding patterns are extremely common with both methods, and a main cause of discontinuation. Advice from normative bodies differs on progestin-only contraceptive use by breastfeeding women 0-6 weeks postpartum. Whether these methods are associated with HIV acquisition is a controversial issue, with important implications for sub-Saharan Africa, which has a disproportionate burden of both human immunodeficiency virus (HIV) and maternal mortality.
Topics: Breast Feeding; Contraception; Contraceptive Agents, Female; Delayed-Action Preparations; Drug Implants; Female; Humans; Injections, Intramuscular; Injections, Subcutaneous; Medroxyprogesterone Acetate; Pregnancy; Progesterone Congeners
PubMed: 24996766
DOI: 10.1016/j.bpobgyn.2014.05.003