Ospemifene is the first oral and non-hormonal treatment for moderate or severe vulvo-vaginal atrophy (VVA) in postmenopausal women who are not candidates to treatment with local oestrogens. Its effects are mediated though the regeneration of the proportion of superficial and intermediate cells of the vagina, improving menopausal symptomatology such as dryness and dyspareunia.
Only two studies to date have directly compared brain activation patterns in women with normal sexual function with women complaining with hypoactive sexual desire disorder. Arnow et al. demonstrated that women with normal sexual function showed brain activations in multiple regions different from women with FSIAD. When comparing the two groups, women with normal sexual function showed greater activation of the bilateral entorhinal cortex while women with FSIAD exhibited greater activation of the medial frontal gyrus, right inferior frontal gyrus, and bilateral putamen. The medial frontal gyrus activation has been associated with self-monitoring; thus, it is possible that women with FSIAD allocate more attention to monitoring their response, which may be inhibitory to sexual functioning. The other study was done by Woodard and colleges showing that women with normal sexual function showed significantly differences on cerebral activation in comparison with women with FSIAD.
These differences observed in women with FSIAD could suggest that they may have alterations in activation of limbic and cortical structures responsible for acquiring, encoding, and retrieving memory, the processing and memory of emotional reactions, and areas responsible for heightened attention to one's own physical state.
For this reason the authors believe that it is essential to determine if the effect of ospemifene on the improvement on sexual function is due to the improvement on the vagina tract or due to its effect on brain function.

Start Date01 Nov 2021

Sponsor / Collaborator

Hospital Clínic de Barcelona

NCT03018106 / TerminatedPhase 4IIT

Ospemifene Versus Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction

Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing postmenopausal female population, and the most common symptom is dyspareunia. Vaginal estrogen is the most common treatment for VVA, but it only marginally improves overall sexual function, and many women and clinicians avoid using it because of the risks of exogenous estrogen use during menopause. Ospemifene is a non-estrogen selective estrogen receptor modulator (SERM) that is FDA-approved for treating dyspareunia related to VVA, and has shown superb improvements in overall sexual health. 104 women will be randomized to receive 12 weeks of 60mg oral ospemifene, taken daily, or 12 weeks of 0.5mg vaginal conjugated estrogens, which is placed vaginally twice per week. The improvements in sexual health and VVA symptom severity will be compared in each group. This study will help determine if ospemifene is a better treatment medication than conjugated estrogens.

Start Date30 Jun 2017

Sponsor / Collaborator

Emory University

NCT02638337 / CompletedPhase 3

A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause

The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.

Start Date26 Jan 2016

Sponsor / Collaborator

Shionogi, Inc.

100 Clinical Results associated with Ospemifene

100 Translational Medicine associated with Ospemifene

100 Patents (Medical) associated with Ospemifene

249

Literatures (Medical) associated with Ospemifene

01 Mar 2024·Clinical obstetrics and gynecology

Hormonal Medications for Genitourinary Syndrome of Menopause

Article

Author: Vaughan, Monique H ; Kaunitz, Andrew M ; Pinkerton, JoAnn V

Genitourinary syndrome of menopause is a common, under-reported, and undertreated chronic progressive condition requiring long-term treatment. Hypoestrogenism in the urogenital tissues is associated with bothersome dyspareunia, vulvovaginal symptoms, overactive bladder, and frequent urinary tract infections. Vaginal hormone therapies, including vaginal estrogen and intravaginal dehydroepiandrostenedione, are safe and effective and improve symptoms and clinical findings. Systemic hormone therapy treats vulvovaginal atrophy less effectively than vaginal hormone therapies with increased stress and urge urinary incontinence. Oral ospemifene effectively treats vaginal dryness and dyspareunia. Clinicians need to ask about symptoms of genitourinary syndrome of menopause, confirm the diagnosis, and suggest appropriate treatment options.

14 Dec 2023·Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology

Vulvovaginal atrophy in the CRETA study: the healthcare professionals’ perception

Article

Author: Baquedano, Laura ; Quijano Martín, Juan José ; González Calvo, A Javier ; Cancelo, María J ; Sánchez Borrego, Rafael ; Corbacho Garza, Tanit ; García Ferreiro, Carmen ; Palacios, Santiago ; Fernández Aller, Noelia

OBJECTIVES:

The objective is to assess the perception of gynecologists regarding patients' adherence to vulvovaginal atrophy (VVA) treatments, to evaluate the gynecologists' opinions on what their patients think about treatment adherence, and to compare the gynecologists' opinions with the patients' own perceptions within the CRETA study.

METHODS:

Spanish gynecologists who participated in the CRETA study were asked to fill out an online 41-item questionnaire to evaluate their views on VVA management.

RESULTS:

From 29 centers across Spain, 44 gynecologists completed the survey. Their mean age was 47.2 years old, two-thirds of them were women, and the average professional experience was over 20 years. According to the gynecologists, the therapy most frequently used by VVA-diagnosed women was vaginal moisturizers (45.5%), followed by local estrogen therapy (36.4%) and ospemifene (18.2%). Nevertheless, ospemifene was viewed as the therapeutic option with the most efficacy, easiest route of administration, shorter time to symptom improvement, lower percentage of dropouts, and higher treatment adherence.

CONCLUSIONS:

Spanish gynecologists are in general agreement with their patients regarding VVA treatment preferences and the main issues for adherence and effectiveness. However, there is an opportunity for doctor-patient communication improvement. Among the three therapeutic options evaluated, ospemifene is regarded as offering some competitive advantages.

01 Dec 2023·Clinical breast cancer

Safety and Serum Estradiol Levels in Hormonal Treatments for Vulvovaginal Atrophy in Breast Cancer Survivors: A Systematic Review and Meta-Analysis

Review

Author: Carvalho, Bruno M ; Moreira, Matheus José Barbosa ; Comini, Ana Carolina M ; Batalini, Felipe ; Colapietro, Luisa ; Reis, Pedro C Abrahão ; Northern, Jane

Vulvo-vaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) is a common condition among breast cancer (BC) patients, especially those undergoing antiestrogen therapy. Despite being an option in refractory cases, the safety of hormonal treatment remains uncertain in this population. The aim of this study was to review the safety and serum estrogen levels of hormonal therapy in patients with BC history presenting with VVA symptoms. Pubmed, Embase, and Cochrane were searched for studies comparing different hormonal treatment options for VVA in breast cancer survivors. Statistical analysis was performed using a random effects model and heterogeneity using Cochran's Q-statistic and the I2 index. We included 17 studies, of which 5 were randomized controlled trials (RCTs). Treatment modalities included in this study were topical vaginal estradiol and estriol preparations, vaginally applied testosterone, DHEA, and ospemifene. We found that, among patients treated with the estriol and estradiol preparations, there was an average increase of 7.67 pg/mL (SMD 7.67 pg/mL; 95% CI -1.00, 16.35; p < .001). Analysis of the testosterone group found temporary peaks of serum estradiol levels, but 1 study showed persistent elevation above normal postmenopausal levels. One study with prasterone revealed no elevation of serum estradiol concentration. One study with ospemifene demonstrated no increase in the risk of BC recurrence. In conclusion, among treatments available for BC survivors, low-dose vaginal estrogen showed the smallest changes in serum estradiol levels and had the most evidence, but safety remains unclear, especially for patients on aromatase inhibitors. Alternative treatments such as ospemifene need more data supporting safety and efficacy. These results suggest that concerns related to cancer recurrence should keep aiming for the lowest possible concentration.

News (Medical) associated with Ospemifene

21 Jun 2022

·www.biospace.com

Duchesnay announces the launch of Vablys® (dequalinium chloride vaginal tablets), an antiseptic and anti-infective treatment for bacterial vaginosis

BLAINVILLE, Quebec, June 21, 2022 (GLOBE NEWSWIRE) -- Duchesnay Inc., a pharmaceutical company specializing in women’s health and part of Duchesnay Pharmaceutical Group headquartered in Blainville, Quebec, is pleased to announce that it has launched its newest treatment, Vablys® (dequalinium chloride vaginal tablets). Vablys® is the first prescription antiseptic and anti-infective treatment for bacterial vaginosis in women under 55 years of age. With its multiple modes of action and anti-infective properties against a wide range of pathogens, a treatment course of Vablys® consists of one tablet inserted in the vagina at bedtime for six consecutive days. “Vablys® offers Canadian physicians and their patients the first gynecological anti infective and antiseptic prescription treatment option,” said Gino Henry, Senior Manager, Commercial Affairs, at Duchesnay. “We’re convinced that our product provides a new and effective way to treat this condition.” 1 Vablys® is the third new prescription treatment for Canadian women launched by Duchesnay in 2022, achieving an aggressive target set by the company’s new management team. The other two new treatments are the contraceptive Slynd® (drospirenone), a progestin-only pill (POP) which offers a 24-hour safe window for a missed pill, during which no other contraception is needed to prevent pregnancy, and Osphena® (ospemifene tablets), a selective estrogen receptor modulator (SERM) approved by Health Canada as a once-daily prescription treatment for postmenopausal women to treat vaginal dryness and painful intercourse. “Duchesnay is very proud to have achieved its ambitious target of bringing three new innovative prescription treatments to Canadian women in the first six months of 2022, a key element of our growth plans under our new management team,” said Dany Hallé, Vice-President, Commercial Affairs at Duchesnay. “All three new treatments address important needs for women at different stages of their lives and demonstrate concretely the commitment of Duchesnay to providing women’s health solutions. We look forward to continuing to do so.” The Health Canada-approved product monographs for Vablys®, Slynd® and Osphena® are available on the Duchesnay website at . They give contraindications, warnings, precautions, adverse reactions, interactions, dosing and conditions of clinical use. The product monographs are also available through the Duchesnay Medical Information Department, 1-888-666-0611 or medicalinfo@duchesnay.com. About bacterial vaginosis Bacterial vaginosis (BV) is an imbalance of the naturally-occurring, healthy bacteria found in the vagina or internal genitals. This imbalance can cause symptoms that may include more vaginal discharge than usual, a fish-like smell or irritation in the vaginal area2, though often symptoms are not noticed. According to the Public Health Agency of Canada, bacterial vaginosis is the most common cause of vaginal discharge in people of reproductive age. Bacterial vaginosis is not usually considered sexually transmitted, but it is associated with increased acquisition of human immunodeficiency virus (HIV), human papilloma virus (HPV) and Chlamydia trachomatis (CT).3 About Duchesnay Pharmaceutical Group Duchesnay Pharmaceutical Group, with its affiliated companies, is headquartered in Blainville, Quebec. The group consists of five pharmaceutical companies to meet the needs of patients in Canada, the U.S. and abroad. The companies are Duchesnay and Duchesnay USA, both dedicated to women's health; Médunik Canada and Medunik USA, which provide treatments for rare diseases; and Analog Pharma, an American generic drugs company, specializing in authorized generics and orphan drugs. From its state-of-the-art manufacturing plant, Duchesnay can export its innovative treatments to more than 50 countries. Duchesnay and Medunik, through their proprietary research and development, and through partnerships, offer innovative treatments for a variety of medical conditions in women's health, urology, oncology as well as for rare diseases. The group of companies recognizes the dedication and professionalism of its employees and promotes a positive culture and flexible work environment. It is deeply committed to environmental responsibility and giving back to the community through the support of various charitable organizations. For more information, please visit duchesnay.com, medunik.com and analogpharma.com. References Duchesnay Inc., Vablys® Product Monograph, September 2021. British Columbia Centre for Disease Control, Bacterial Vaginosis, Health Canada, STI-associated syndromes guide: Vaginitis, Public Health Importance, September 2021, Media contact: Email: info@duchesnay.com Telephone: (877) 833-7734 A photo accompanying this announcement is available at Vablys Vablys

Orphan DrugGeneric DrugAcquisition

31 Oct 2017

·www.bioportfolio.com

Shionogi Inc 4507 Pharmaceuticals Healthcare Deals and Alliances Profile [Report Updated: 26102017] Prices from USD $250

Summary Shionogi Inc Shionogi, formerly Sciele Pharma, Inc., is a pharmaceutical company. It undertakes the development and commercialization of pharmaceutical products to address the unmet medical needs. The company offers a wide range of branded prescription products to treat chronic diseases. It markets products for various therapeutic areas such as pain, antiinfectives, women's health, pediatrics, cardiovascular, diabetes and others. Shionogi offers its products in various formulations such as tablets, oral suspensions solutions, lotions, capsules, chewable tablets and injections. Some of the company's key branded products include Doribax, Fortamet, Triglide, Altoprev, Fexmid, Methylin, Osphena and Furadantin, among others. The company is a subsidiary of Shionogi Co Ltd Shionogi is headquartered in Florham Park, New Jersey, the US. Shionogi Inc 4507 Pharmaceuticals Healthcare Deals and Alliances Profile provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Pharma eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.

Acquisition

100 Deals associated with Ospemifene

External Link

KEGG	Wiki	ATC	Drug Bank
D08958	Ospemifene	G03XC05	DB04938

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
vaginal mucosa dry	US	Duchesnay, Inc.	25 Jan 2019
Vulvovaginal atrophy	EU	Qualicaps Netherlands BV	14 Jan 2015
Vulvovaginal atrophy	IS	Qualicaps Netherlands BV	14 Jan 2015
Vulvovaginal atrophy	LI	Qualicaps Netherlands BV	14 Jan 2015
Vulvovaginal atrophy	NO	Qualicaps Netherlands BV	14 Jan 2015
Dyspareunia	US	Duchesnay, Inc.	26 Feb 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Atrophy	Phase 3	-	Shionogi, Inc.	01 Jan 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02638337 (CTgov)	Phase 3	Vulvovaginal atrophy \| vaginal mucosa dry	631	Ospemifene (Ospemifene)	rypmqdnfxl(setfvshgqb) = jxxdtiosdp gksvfukkun (afkftlodud, hwrimxwurj - yvwetpvsoy) View more	-	02 Apr 2019
				Placebo (Placebo)	rypmqdnfxl(setfvshgqb) = mqjfamczzt gksvfukkun (afkftlodud, aylaefhodn - nuodrtcokl) View more
NCT02638337 (Pubmed \| Menopause)	Phase 3	vaginal mucosa dry	631	Ospemifene 60mg	qiovfbcmnp(lffdojogrq) = jdizfduvle fjosfnjgcx (rrtlaikyhj ) View more	Positive	28 Jan 2019
				Placebo	qiovfbcmnp(lffdojogrq) = azlqjbdnwp fjosfnjgcx (rrtlaikyhj ) View more
NCT03018106 (CTgov)	Phase 4	Sexual Dysfunction, Physiological \| Sexual Dysfunction	1	Vaginal conjugated estrogens	fsfinalxts(ywqqwcyoif) = yvtaiabcoz qbrvuktwin (lgseeubjyo, lhxqclckbt - qcagzcembi) View more	-	20 Dec 2017
NCT00276094 (CTgov)	Phase 3	Vulvovaginal atrophy \| Atrophy	826	Nonhormonal vaginal lubricant+Ospemifene 30 mg (Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant)	xztysqwwwe(mualwwtfqt) = mmyuivaowr fobeebilfu (hrlvvpqibd, sdvbpmifzs - ozdzbkshzj) View more	-	28 Jun 2013
				Nonhormonal vaginal lubricant+Ospemifene 60 mg (Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant)	xztysqwwwe(mualwwtfqt) = ntwlauoeyx fobeebilfu (hrlvvpqibd, apxgbexvjp - bjvmsurnak) View more
NCT01586364 (CTgov)	Phase 3	Vulvovaginal atrophy \| Atrophy	301	Ospemifene	woqmpodcei(ymmpwtbqcv) = ufjawgtuse xpmjxkvoet (elddbqtsts, qklinnkayx - ircxfmxudc) View more	-	28 Jun 2013
NCT00630539 (CTgov)	Phase 2	Vulvovaginal atrophy \| Atrophy	126	Placebo (Subjects on Placebo)	vupptbvsmw(ahujuynpjm) = eqphpwndej milzpkclaq (piddyjajzk, jrgygtywqe - fopngzzsci) View more	-	28 Jun 2013
				Ospemifene 5 mg (Subjects on Ospemifene 5 mg/Day)	vupptbvsmw(ahujuynpjm) = pirgoiyrwc milzpkclaq (piddyjajzk, gfqtonysok - slnsdakffw) View more
NCT00566982 (CTgov)	Phase 3	Vulvovaginal atrophy \| Atrophy	426	Placebo (Subjects on Placebo (Baseline))	vfmpgperdo(xenxyrdbzs) = tcdckdimzf picuhjkxoi (pioclnryhg, sciaslkczx - jqzhtpaoog) View more	-	28 Jun 2013
				Ospemifene (Subjects on Ospemifene 60 mg/Day (Baseline))	vfmpgperdo(xenxyrdbzs) = njgtyllkbu picuhjkxoi (pioclnryhg, ktomoikacq - wrfitkplbz) View more
NCT01585558 (CTgov)	Phase 3	Vulvovaginal atrophy \| Atrophy	180	Ospemifene (Ospemifene 30 mg (Dose 1))	fcdttcdmbw(yggopjnqna) = xvzdhfihtj wxstgkjxgv (zjvdhjlkxr, dkvndtsjdk - cdoeogopey) View more	-	28 Jun 2013
				Ospemifene (Ospemifene 60 mg (Dose 2))	fcdttcdmbw(yggopjnqna) = mehvyylkss wxstgkjxgv (zjvdhjlkxr, gnamoazkzp - zdpmebcofi) View more
NCT00729469 (CTgov)	Phase 3	Vulvovaginal atrophy \| vaginal mucosa dry \| Atrophy	919	Placebo (Subjects on Placebo)	pldegjpouv(cchpsazhrf) = ezautwicoy girkaybitk (nnpguvsapk, tlfozmqnft - oisppopdht) View more	-	28 Jun 2013
				Ospemifene (Subjects on Ospemifene 60 mg/Day)	pldegjpouv(cchpsazhrf) = bjiqudqpgj girkaybitk (nnpguvsapk, yjudmihads - vfetwhyoty) View more

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