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Jaime Algorta, Maria Diaz, Raquel de Benito, Marc Lefebvre, Eric Sicard, Milton Furtado, Pedro Antonio Regidor, Celestino Ronchi
OBJECTIVE: To show the clinical development of Ornibel® (ExeltisHealthcare, Spain) a contraceptive vaginal ring manufactured with a new polymer composition and containing etonogestrel/ethinylestradiol, compared to Nuvaring® (MSD, Spain). SUBJECTS AND METHODS: Randomised, single dose, 2-period, 2-sequence, 2-stage crossover, comparative bioavailability study conducted in 40 healthy female subjects. All subjects received both treatments for 28 days in each of two periods, separated by a 28 days washout...
December 2017: European Journal of Contraception & Reproductive Health Care
Simone Eder, Michela Beretta, Andreas Witschnigg, Ioannis Koutsamanis, Karin Eggenreich, Johannes G Khinast, Gerold Koscher, Amrit Paudel, Klaus Nickisch, Maika Friedrich, Eleonore Froehlich, Eva Roblegg
Co-extrusion offers a number of advantages over conventional manufacturing techniques. However, the setup of a co-extrusion line is cost- and time-intense and formulation development is challenging. This work introduces a novel procedure to test the applicability of a co-extruded reservoir-type system at an early product development stage. We propose vacuum compression molding (VCM), a fast procedure that requires only small material amounts, for the manufacturing of cylindrical reservoir-type system. To this end, the commercially available co-extruded product NuvaRing(®) and variations thereof were used as test systems...
November 2017: AAPS PharmSciTech
Elena Morotti, Paolo Casadio, Francesca Guasina, Bruno Battaglia, Mara Mattioli, Cesare Battaglia
INTRODUCTION: Oral contraceptives could induce mood changes. As far as our knowledge, there are no studies in literature that have examined the role of vaginal contraception in self-perceived body image. AIM: To evaluate the effects of intravaginal contraception on weight gain and perceived body image in relation with the Beck's Depression Inventory questionnaire (BDI) and the McCoy Female Sexuality Questionnaire (MFSQ). METHODS: Twenty-one adult (18-35 years old) eumenorrheic (menstrual cycle of 25-35 days), lean (body mass index - BMI - of 19-25 kg/m(2)) women who were referred for hormonal contraception were administered the Stunkard Figure Rating Scale (FRS), BDI and MFSQ...
April 17, 2017: Gynecological Endocrinology
Richard E Haaland, Angela Holder, Tammy Evans-Strickfaden, Beatrice Nyagol, Mumbi Makanga, Boaz Oyaro, Felix Humwa, Tiffany Williams, Eleanor McLellan-Lemal, Mitesh Desai, Michael J Huey
OBJECTIVE: This study sought to measure residual contraceptive hormone levels in vaginal rings as an adherence marker for monitoring product use in clinical trials. STUDY DESIGN: Residual etonogestrel and ethinyl estradiol levels from used NuvaRings® of 26 self-reported adherent women enrolled in a clinical trial of vaginal ring acceptability were compared to those from 16 women who used NuvaRing® as their contraceptive choice. RESULTS: Twenty-one (81%) clinical trial rings had contraceptive hormone levels within the range of those used as a contraceptive choice...
June 2017: Contraception
Prad Selvan, Pirouz Piran, Clotilde Balucani, Brian Tark, Zachary Adler, Steven R Levine
BACKGROUND: A recent study found that NuvaRing (a vaginal contraceptive ring containing 15 µg ethinyl estradiol and 120 µg etonogestrel) has 2.5 times increased relative risk of thrombotic stroke compared to nonuse. OBJECTIVE: We studied a case series of 19 such patients as well as prior published case reports to clarify clinical, radiological, and prognostic features. METHODS: Medical records and imaging for 18 cases were initially systematically reviewed for consultation in a class action lawsuit...
March 2017: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
Samet Özer, Resul Yilmaz, Ergün Sonmezgoz, Şeyma Ünuvar, Ömer Ates
Familial Mediterranean fever (FMF) is an autosomal recessively inherited disease characterized by recurrent self-limited attacks of fever accompanied by aseptic inflammation of serosal spaces, joints and skin, peritonitis, pleuritis, and arthritis. Clinical features differ according to genetics variants. The aim of this study was to identify relationship between IL-6 -174G/C gene polymorphisms and clinical features, disease severity score (DSS) and proteinuria in children diagnosed with FMF. In this study, 99 children who were followed-up in Gaziosmanpasa University Medical Faculty Department of Pediatrics and diagnosed with Familial Mediterranean fever according to Tel-Hashomer criteria were included...
December 2016: Biochemical Genetics
Guang Sheng Fan, Mulan Ren, Wen Di, Ping Su, Qin Chang, Shuying Wu, Yun Qin, Tjeerd Korver, Maya Marintcheva-Petrova, Carol Yacik, Christine McCrary Sisk, Guoqin Wang
OBJECTIVES: The aim of the study was to assess the efficacy and tolerability of the monthly vaginal ring (NuvaRing; 15 μg ethinylestradiol [EE] and 120 μg etonogestrel per day) compared with a monophasic (21/7) combined oral contraceptive (COC) containing 30 μg EE and 3 mg drospirenone in healthy Chinese women aged 18-40 years. METHODS: This was a phase III, open-label, randomised multicentre trial conducted in China. Participants received NuvaRing or COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-free/pill-free period)...
August 2016: European Journal of Contraception & Reproductive Health Care
Robert Feldman, Tara L Frenkl, Carol Yacik, Yinna Wang, Michelle C Fox
INTRODUCTION: We assessed performance and safety of the NuvaRing® Applicator. METHODS: We randomized women (18-45 years) to insert a placebo ring using the applicator or fingers-only and then vice versa. We assessed outcomes post-insertion and then 24-72 h later. RESULTS: Insertion was 100% successful using both methods (applicator, n=163; fingers-only, n=162). A total of 8.6% (applicator) and 4.3% (fingers-only) of subjects reported at least 1 treatment-related adverse event (AE); all were mild...
October 2016: Contraception
Sandhya Jain, Neelam B Vaid, Yam Narang, Amita Suneja, Kiran Guleria
INTRODUCTION: Combined Oral Contraceptive (COC) pills are being used in patients of abnormal uterine bleeding, especially adolescents and reproductive age women considering their need for contraception. It decreases the blood loss due to haemostatic effect of estrogen and also regularizes the cycle. Intravaginal route has been found to be effective and acceptable; Gastrointestinal absorption and hepatic first-pass metabolism is avoided and steady, uniform blood concentration is achieved...
March 2016: Journal of Clinical and Diagnostic Research: JCDR
Ian Major, Evert Fuenmayor, Christopher McConville
Non-degradable polymers have an important function in medicine. Solid dosage forms for longer term implantation require to be constructed from materials that will not degrade or erode over time and also offer the utmost biocompatibility and biostability. This review details the three most important non-degradable polymers for the production of solid dosage forms - silicone elastomer, ethylene vinyl acetate and thermoplastic polyurethane. The hydrophobic, thermoset silicone elastomer is utilised in the production of a broad range of devices, from urinary catheter tubing for the prevention of biofilm to intravaginal rings used to prevent HIV transmission...
2016: Current Pharmaceutical Design
Robert J Paresi, Robert S Myers, Alan Matarasso
UNLABELLED: Nuvaring (Organon, Kenilworth, NJ) is a vaginal contraception ring inserted by the patient. It was approved by the Food and Drug Administration in 2001 for the prevention of pregnancy. The intent of this paper is to increase the awareness of Nuvaring among plastic surgeons, and to explore the risks associated with its use. We report the cases of two cosmetic surgery patients. These patients developed deep venous thrombosis and pulmonary emboli in the postoperative period while using Nuvaring...
August 2015: Aesthetic Surgery Journal
Kevin S Baker, Matthew Barish
The NuvaRing® is a deformable, ring-shaped hormonal contraceptive device which is typically vaginally self-inserted by the patient. While there are several potential side effects of usage, essentially all of them result from hormone delivery. Complications from incorrect placement are rare. We present the case of a 31 year old female who presented to our emergency department after being unable to retrieve a NuvaRing® for its scheduled removal. CT scan showed a hypodense intravesicular NuvaRing® which the patient had inadvertently placed transurethrally 3 weeks prior...
December 2014: Journal of Radiology Case Reports
David R Friend
Intravaginal rings (IVRs) are a dosage form used to locally or systemically deliver drugs in the vagina. They are capable of releasing one or more drugs over an extended period of time (from several weeks to a year or longer). Contraceptive IVRs are currently gaining popularity due to the success of the contraceptive product NuvaRing®. Delivery of contraceptives from IVRs should promote compliance/adherence, and they also provide effective cycle control and symptom relief (menorrhagia, dysmenorrheal, and polycystic ovarian syndrome)...
June 2011: Drug Delivery and Translational Research
Katherine G Michel, Richard P H Huijbregts, Jonathan L Gleason, Holly E Richter, Zdenek Hel
OBJECTIVE: Epidemiological evidence suggests an association between the use of hormonal contraception and an increased risk of acquiring sexually transmitted diseases including HIV-1. We sought to elucidate the biological mechanisms underlying the effect of hormonal contraception on the immune system. DESIGN: Cross-sectional study. METHODS: To delineate the biological mechanisms underlying the effect of hormonal contraceptives on the immune system, we analyzed the functional capacity of circulating plasmacytoid dendritic cells (pDCs), the distribution of vaginal immune cell populations, and the systemic and genital levels of immune mediators in women using depot medroxyprogesterone acetate (DMPA), NuvaRing, or combined oral contraceptives (COC)...
April 15, 2015: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Suchitra N Pandit, Anahita R Chauhan, Manjula Anagani, Sanjeeva Reddy, Ashish Birla, Subrat K Ray
OBJECTIVE: This was the first Indian multicenter study at six specialty hospitals, to assess the real-life usage of the vaginal ring in daily clinical practice. METHODS: This open-label, prospective, single-arm, nonrandomized, interventional study enrolled 252 women aged >18 years, seeking contraception with no contraindications to the use of combined hormonal contraceptive. Women were provided the ring with a monthly follow-up schedule for three cycles. Cycle control, acceptability, tolerability, and safety assessments were recorded at each visit...
December 2014: Journal of Obstetrics and Gynaecology of India
Brian Trung Nguyen, Jeffrey T Jensen
INTRODUCTION: Multiple studies confirm the safety and efficacy of the combined ethinyl estradiol (EE) and etonogestrel contraceptive vaginal ring (NuvaRing®). Advantages of continuous drug delivery through the vagina compared to oral administration include stable levels of contraceptive steroids without the need for daily drug administration. Although the combined contraceptive vaginal ring (CCVR) avoids the problem of missed pills, clinical data do not support greater efficacy. Vaginal administration avoids first-pass hepatic effects; however, EE is a potent inducer of hepatic globulins regardless of the route of administration...
October 2014: Expert Opinion on Drug Safety
Timothy L Vo, Rhett M Cook, Matthew T Rondina, David Kaplan
We present a case of a 27-year-old women admitted to the hospital with migraine and left upper extremity weakness. Subsequent imaging with computed tomography and magnetic resonance angiography/venography demonstrated an acute-appearing central venous sinus thrombosis. Her only risk factor for venous thromboembolism (VTE) was the use of etonogestrel/ethinyl estradiol vaginal contraceptive ring (NuvaRing). The contraceptive ring was removed and the patient was treated according to the current guidelines. She achieved full neurologic recovery at 6 months' follow-up...
March 2014: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
Tiffany Thomas, Kelsey Petrie, Joonho Shim, Kirsten M Abildskov, Carolyn L Westhoff, Serge Cremers
INTRODUCTION: Etonogestrel (ENG) is a progestin used in the contraceptive vaginal ring NuvaRing and the subdermal implant Implanon. A sensitive method for measuring ENG is useful for further investigating the progestin's pharmacokinetics with these alternative contraceptive formulations and generating important information about possible continued efficacy or potential failure to remove the subdermal implant. METHODS: Standards and serum samples were spiked with D8-progesterone (internal standard) and subsequently extracted with dichloromethane, dried, and reconstituted in 25% methanol with formic acid...
December 2013: Therapeutic Drug Monitoring
Rossella E Nappi
BACKGROUND: Healthcare providers (HCPs) have an important role in helping women select the contraceptive method that best matches their needs and lifestyle. Recent surveys outline the need of women to be informed about all available choices, including the newest methods (particularly those not requiring daily administration), such as vaginal contraception. METHODS: The most relevant publications on combined contraceptive vaginal ring are revised in the context of counseling as an opportunity to empower women in term of vaginal health and sexual functioning...
December 2013: Gynecological Endocrinology
Anna Externbrink, Meredith R Clark, David R Friend, Sandra Klein
The objective of the present study was to investigate if temperature can be utilized to accelerate drug release from Nuvaring®, a reservoir type intravaginal ring based on polyethylene vinyl acetate copolymer that releases a constant dose of contraceptive steroids over a duration of 3 weeks. The reciprocating holder apparatus (USP 7) was utilized to determine real-time and accelerated etonogestrel release from ring segments. It was demonstrated that drug release increased with increasing temperature which can be attributed to enhanced drug diffusion...
November 2013: European Journal of Pharmaceutics and Biopharmaceutics
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