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Vaginal in Medical Technology

Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms

... severity of hot flushes and improved measures of vaginal atrophy when compared to placebo. In this study, ... such as hot flushes, night sweats and vulvar and vaginal atrophy, and for the prevention of postmenopausal ... vasomotor symptoms at four and 12 weeks, vaginal maturation index at six months, menopause-related ...

QuatRx Completes Enrollment of Ophena(TM)(Ospemifene Tablets) Final Pivotal Phase 3 Study in Women with Postmenopausal Vaginal Atrophy

... currently in development for the treatment of vaginal symptoms associated with menopause. A total of ... NDA filing under the published FDA guidance for vaginal atrophy. "We are pleased to have achieved ... months, in what we believe to be the largest vaginal atrophy study ever conducted," said Robert L. ...

New PRO2000 HIV-Prevention Findings Important Milestone on Path Toward Development of Effective Vaginal Microbicide

... and PRO2000 (0.5 percent concentration), both vaginal gels being tested to prevent HIV transmission to ... sex. BufferGel's primary action is to lower vaginal pH while PRO2000 is a large charged polymer ... because they confirm the fundamental premise of vaginal microbicide science: that a woman can use a ...

Indevus Pharmaceuticals Announces PRO 2000 Found to Show Promise in Large HIV Prevention Study

... who received PRO 2000, the Company's candidate vaginal microbicide for HIV prevention, had an ... infection than women who received a placebo or no vaginal product. All women participating in the study ... of PRO 2000 and another investigational vaginal microbicide (BufferGel(R), ReProtect, Inc.) in ...

Bionovo's VG101 Shows Greater Efficacy Than Estrogen in the Treatment of Vaginal Dryness

... new drug candidate, VG101, for the treatment of vaginal dryness, at the 19th Annual Meeting of the North ... VG101, is designed to treat postmenopausal vaginal dryness, a condition that affects over 40 million ... women refrain from sexual activity is due to vaginal dryness. Considering the lack of safe treatment ...

QuatRx Pharmaceuticals Announces Additional Data From Phase 3 Study for Ophena(TM) (Ospemifene Tablets) Showing Improvements in Clinical Symptoms of Vulvovaginal Atrophy

... survey shows high prevalence of "bothersome" vaginal atrophy symptoms among sexually active and ... showed statistically significant improvements in vaginal dryness and dyspareunia (painful intercourse), ... demonstrated favorable effects of Ophena(TM) on vaginal wall health as compared to placebo, measured ...

Nationwide Survey Shows Infertility Patients Prefer ENDOMETRIN(R) Compared With Other Progesterone Supplements

... that patients prefer ENDOMETRIN(R) (progesterone) vaginal Inserts to progesterone-in-oil (PIO) injections, and to all other vaginal progesterone supplements. The reasons cited most ... There are several forms: oral, injection, and vaginal -- tablet ...

QuatRx Initiates Second Phase 3 Study of Ophena(TM) (Ospemifene Tablets) in Women With Postmenopausal Vaginal Syndrome

... (SERM) for the treatment of postmenopausal vaginal syndrome (PVS), a common condition in postmenopausal women. PVS, also known as vaginal atrophy, is characterized by progressive long-term vaginal symptoms such as dryness, irritation and sexual ...

Indevus Pharmaceuticals Announces Completion of Enrollment in Phase III Trial of PRO 2000

... trial of PRO 2000, the Company's candidate vaginal microbicide for the prevention of HIV and ... effectiveness of PRO 2000 and another candidate vaginal microbicide in preventing HIV infection in women. ... (MDP) is an Afro-European partnership to develop vaginal microbicides for the prevention of ...

Quatrx Pharmaceuticals Presents Results From Ophena(TM) (Ospemifene Tablets) Phase 3 Study Related to Treatment of Symptoms of Vulvovaginal Atrophy

... among women affected by moderate to severe vaginal dryness and painful ... showed statistically significant improvements in vaginal dryness and dyspareunia (painful intercourse), ... and superficial cells in the epithelium of vaginal walls and a decline ...

QuatRx Pharmaceuticals Announces Presentation of Further Data from Ophena(TM) (Ospemifene) Phase 3 Study for Treatment of Symptoms of Vulvovaginal Atrophy

... the Menopause show significant improvement in vaginal dryness and dyspareunia, two of the most frequent ... with Ophena(TM) experienced improvements in vaginal dryness and dyspareunia (painful intercourse), ... in the study experienced moderate to severe vaginal dryness and 66% experienced moderate to severe ...

Divigel(R) (estradiol gel) 0.1 Percent Offers Lowest Approved Dose of Estradiol for Treatment of Moderate to Severe Hot Flashes Associated with Menopause

... getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking ... products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps ... and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness ...

Schering-Plough Announces Imperfect Contraceptive Use Impacts Women's Emotional Well-Being

... and NUVARING(R) (etonogestrel/ethinyl estradiol vaginal ring), the vaginal ring. "The study included questions about ... skin patch (61.7 percent and 19 percent) or the vaginal ring (58.3 percent and 16.4 percent) (p<0.0001). ...

Microbicide Developer Receives License for Novel HIV Microbicide Candidate From Merck & Co., Inc.

... antiretroviral compound for use as a potential vaginal microbicide. The compound, called L'644, is a ... to prevent HIV transmission during vaginal intercourse. IPM is also developing other delivery methods, such as long-lasting vaginal rings that would release the drug gradually over ...

QuatRx Pharmaceuticals Announces Positive Phase 3 Results for Study of Ophena(TM) (ospemifene) to Treat Postmenopausal Vaginal Syndrome

... vaginal syndrome (PVS), also known as vaginal atrophy. PVS is a common condition in postmenopausal women characterized by symptoms such as vaginal dryness, irritation and pain associated with ... with moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. A total of 826 ...

Wyeth Presents New Phase 3 Data and Updates Regulatory Timing for NDA Filing of Bazedoxifene/Conjugated Estrogens

... estrogens improved symptoms of vulvar and vaginal atrophy. In addition, secondary data from both ... which may provide relief of hot flashes and vaginal dryness as well as bone and uterine protection." ... women with moderate to severe vulvar and vaginal atrophy, also were presented. These data showed ...

Sexual Function Affected by Stem Cell Transplant According to Long-Term Study

... this study, may cause shrinkage of the vaginal tissues and changes to the vaginal lining that can contribute to sexual dysfunction ... strategies for enhancing libido, and use of vaginal lubricants, dilators, or vibrators to assist with ...

QuatRx Completes Patient Enrollment in Phase 3 Study of Ophena(TM) in Women with Postmenopausal Vaginal Syndrome

... receptor modulator (SERM) for postmenopausal vaginal syndrome (PVS), a common condition in postmenopausal women sometimes referred to as vaginal atrophy and characterized by vaginal symptoms such as dryness, irritation and ...

Georgia Reproductive Specialists Participates in Largest-Ever In Vitro Fertilization Clinical Trial in the World

... times daily, or an active control ((progesterone vaginal gel (90 mg) QD)).* In the study, 97 percent of ... ENDOMETRIN administered as a progesterone vaginal insert is indicated to support embryo ... percent included: uterine spasm (3% to 4%) and vaginal bleeding ....

Gallbladder Removal Through Vagina Offers Minimally Invasive Alternative

... Memorial are among the first groups in the U.S. to successfully complete vaginal natural orifice translumenal endoscopic surgery or NOTES CHICAGO, ... device, called an endoscope, is inserted through a small incision in the vaginal wall and into the abdomen. Currently, laparoscopic assistance is used as a ...

Reproductive Partners Participates in New IVF Progesterone Delivery System Study

... to these painful injections. The study compares an FDA-approved vaginal progesterone, Endometrin, with a new formulation which is administered ... drug injections. Patients will be randomized to receive either the vaginal or subcutaneous progesterone until the pregnancy test and then until about ...

First Published Study of New HPV Test for Developing Countries Shows High Accuracy in Predicting Cervical Disease

... by healthcare workers were used, and 81 percent when women used a vaginal "self-sampling" device. In this study, careHPV was more sensitive even ... with minimal healthcare training and education. Once collected, samples of vaginal or cervical cells are prepared for analysis using a kit of reagents that ...

Indevus Pharmaceuticals Provides Update on PRO 2000 Program

... from the Phase III clinical trial of PRO 2000, the Company's candidate vaginal microbicide for HIV prevention, the Independent Data Monitoring Committee ... to examine the safety and effectiveness of PRO 2000 and another candidate vaginal microbicide (BufferGel, Reprotect, Inc.) in preventing HIV infection in ...

Estrogen Getting Cool Reception From Dermatologists for Mixed Results in Improving Appearance of Skin

... that it is drier than normal. In order to treat the most common symptoms associated with menopause -- including hot flashes, mood swings and vaginal changes -- physicians often prescribe hormone replacement therapy (HRT) to boost the body's estrogen levels that drop dramatically during this change ...

Cytokine PharmaSciences Initiates Phase I Study of Oral Anti-Inflammatory Agent, CPSI-2364

... products and has a strong focus in the area of women's health, including manufacturing the successful cervical ripening product, the Cervidil(R) vaginal insert (Propess(R) in Europe and elsewhere). Cytokine PharmaSciences has three products in clinical development and employs 70 people at its ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... pain, night sweats, weight gain, nausea, tiredness, other heart-related events and bone fractures. Other less commonly reported side effects include vaginal bleeding, blood clots, other cancers, osteoporosis, stroke, heart attack and endometrial cancer. In the extended adjuvant setting, commonly ...

Ferring Pharmaceuticals Unveils Six-Month Efficacy Data for EUFLEXXA(R) for the Treatment of Osteoarthritis Knee Pain

... MENOPUR(R) and REPRONEX(R) (menotropins for injection, USP), Novarel(R) (chorionic gonadotropin for injection, USP), ENDOMETRIN(R) (progesterone) vaginal Insert, 100 mg, PROSED(R) DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, DEGARELIX for ...

Study Reported Tadalafil Taken Once Daily Improved Erectile Function in Men with ED and Sexual Quality of Life in Couples

... reported a 28.6 percent increase on average (compared with 2.7 percent in the placebo group) in the ability to achieve an erection sufficient for vaginal penetration. When asked if their erections lasted long enough for successful intercourse, men in the tadalafil group reported a 46 percent increase ...

Ferring Pharmaceuticals Launches Phase IIIB Trial of Degarelix as Intermittent Therapy

... MENOPUR(R) and REPRONEX(R) (menotropins for injection, USP), Novarel(R) (chorionic gonadotropin for injection, USP), ENDOMETRIN(R) (progesterone) vaginal Insert, 100 mg, PROSED(R) DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, DEGARELIX for ...

Newly Published Phase III Study Shows Arzoxifene Significantly Increased Bone Mineral Density

... difference overall in the number of subjects reporting adverse events in the arzoxifene group compared with the placebo group, with the exception of vaginal yeast infection (arzoxifene 4%, placebo 0%, p=0.02). New or worsening hot flushes were not significantly different between the arzoxifene ...

Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista(R) (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis

... within-group differences in change of percentage of breast density. The proportion of women reporting one or more adverse events, including vaginal bleeding, did not differ between treatment groups. No cases of endometrial polyps, hyperplasia or cancer were reported. ...

Fertility Physicians of Northern California Researchers Test New Forms of Progesterone Medication for Luteal Support During IVF

... forms of this medication can be painful for patients. Formulations of progesterone medication which can be administered by subcutaneous injection or vaginal suppository may offer similar results with better patient tolerance. With patient well-being a constant focus, Fertility Physicians ...

Video: Femara(R) First Aromatase Inhibitor to Indicate Survival Benefit Versus Tamoxifen When Taken for Five Years After Breast Cancer Surgery

... pain, night sweats, weight gain, nausea, tiredness, other heart-related events and bone fractures. Other less commonly reported side effects include vaginal bleeding, blood clots, other cancers, osteoporosis, stroke, heart attack and endometrial cancer. In the extended adjuvant setting, commonly ...

More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies

... pain, night sweats, weight gain, nausea, tiredness, other heart-related events and bone fractures. Other less commonly reported side effects include vaginal bleeding, blood clots, other cancers, osteoporosis, stroke, heart attack and endometrial cancer. In the extended adjuvant setting, commonly ...

Gaining Too Much Weight During Pregnancy Nearly Doubles Risk of Having a Heavy Baby

... Permanente Center for Health Research in Oregon and Hawaii. "A big baby also poses serious risks for both mom and baby at birth -- for mothers, vaginal tearing, bleeding, and often C-sections, and for the babies, stuck shoulders and broken collar bones." While researchers have known for some time ...

Study Shows EUFLEXXA(R) Patients Report Significant Improvements in Osteoarthritis of the Knee Pain over a Six Month Period

... USP); REPRONEX(R) (menotropins for injection, USP); NOVAREL(R) (chorionic gonadotropin for injection, USP) and ENDOMETRIN(R) (progesterone) vaginal Insert for infertility. Ferring offers the Q?CAP(TM), the first needle-free reconstitution device, for use with its fertility treatments. Other ...

New Analyses Indicate that Divigel(R) (estradiol gel) 0.1% Is a Valuable Option for Certain Postmenopausal Women With Hot Flashes

... abnormalities. The most frequently reported adverse events in Divigel(R) clinical trials were nasopharyngitis, upper respiratory tract infection, vaginal mycosis, breast tenderness and metrorrhagia. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the ...

Xoft Showcases Interim Clincal Results for Breast Cancer Product and New Indications for Electronic Brachytherapy(eBx) at Astro Meeting

... Dickler, MD, Department of Radiation Oncology, Little Company of Mary Hospital, Evergreen Park, IL, will review early experience with Xoft Axxent vaginal cylinders in the treatment of endometrial cancer and Little Company's early experience utilizing the Axxent System to deliver Intraoperative ...

China Sky One Medical, Inc. Announces 26 New Drugs in Clinical Trials

... Drug Administration (SFDA) in the PRC for approval. -- Four drugs, including Cleaning suppositories, Tinidazole suppositories, Policresulen vaginal suppositories, and Aciclover gel are for the treatment of vaginits; -- Three drugs, including Chlorhexidine Gluconate, Cetylpyridinium ...

Neurocrine Biosciences Announces Successful Elagolix PETAL Study in Endometriosis

... mg once daily (5%) or 75 mg twice daily (7%). This increased discontinuation in women randomized to DMPA was primarily attributable to irregular vaginal bleeding. The overall rate of AE reporting was comparable across all groups. The most common AE was headache; this was reported 35 times by 19 women ...
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