Delving into the Latest Updates on Prasterone with Synapse

The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (GSM) due to natural, surgical or treatment-induced menopause and the effect on the quality of life, including sexual function and mood well-being, in women with Breast Cancer. A sample size of 95 patients will be needed to show that the proportion of women showing symptom improvement is greater than 50%. Subjects will be followed up at four weeks and twelve weeks of treatment. One and three-month outcomes will be provided after the end of treatment. Comparison between menopausal women with previous breast cancer that have finished hormonal therapy or with ER negative breast cancer and women currently under endocrine therapy with AIs will be performed.

Start Date01 Dec 2024

Sponsor / Collaborator

Istituto Europeo di Oncologia SRL

NCT05900661 / Not yet recruitingPhase 2/3IIT

The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders Undergoing ICSI : an Open Label Randomized Clinical Trial.

To evaulate the role of Myo-inositol, somatropin, DHEA on ICSI outcome in poor ovarian responder

Start Date30 Jul 2023

Sponsor / Collaborator

Beni-Suef University

NCT05562518 / RecruitingPhase 4IIT

GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.

In this prospective active-controlled randomized trial the investigators will assess for the first time ever the different local treatments of vulvovaginal atrophy in breast cancer patients on endocrine therapy. These patients are currently inadequately treated based on ignorance of possible treatment modalities and stigmatization of vulvovaginal atrophy.

Start Date21 Mar 2022

Sponsor / Collaborator

Ghent University Hospital

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100 Clinical Results associated with Prasterone

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100 Translational Medicine associated with Prasterone

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100 Patents (Medical) associated with Prasterone

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8,680

Literatures (Medical) associated with Prasterone

01 Mar 2025·BONE

Hormones synthesized by the adrenal reticulum protect bone density in premenopausal women with Cushing syndrome

Article

Author: Sang, Hequn ; Wu, Keyang ; Chang, Lina ; He, Qing ; Liu, Ming ; Ye, Yuanyuan ; Li, Shuo ; Ding, Li ; Yuan, Hengjie ; Gu, Yian ; Wan, Jieying ; Yan, Siyu

BACKGROUND:

Differences in bone metabolism between patients with adrenal Cushing's syndrome (ACS) and Cushing's disease (CD) have been noted, but the impact of steroid hormones on bone metabolism remains underexplored. The purpose of this study is to explore the differences in bone metabolism between the two subtypes of Cushing's syndrome and the correlation between hormones synthesized by the adrenal reticulum and bone metabolism.

METHOD:

This retrospective study included 75 premenopausal women, consisting of 33 patients with CD and 42 patients with ACS. The clinical characteristics, laboratory examination and bone metabolism differences between the two groups were analyzed. Then, 16 patients with ACS and 12 patients with CD underwent comparison of blood steroid hormone levels. Additionally, the relationship between bone mineral density (BMD) values and steroid hormone variables was analyzed.

RESULTS:

The serum and urinary cortisol and serum ACTH concentrations were significantly higher in patients with CD compared to those with ACS. Conversely, lumbar and femoral BMD were lower, and osteocalcin (OC) levels were elevated in the ACS group. Dehydroepiandrosterone (DHEA) and dehydroepiandrosterone-sulphate (DHEAS) had a significant positive correlation with Z-score in lumbar spine in both CD and ACS group. However, Z-score in femoral neck had a significant positive correlation with DHEA and DHEAS only in the ACS group.

CONCLUSION:

Bone loss is more pronounced in ACS than in CD, despite higher cortisol levels in CD patients. High levels of hormones synthesized by the adrenal reticulum might be protective for bone density in premenopausal women with hypercortisolism.

01 Feb 2025·Clinical Nutrition ESPEN

Effects of time-restricted feeding and weight-loaded swimming test on androgen levels and androgen receptor expression in orchiectomized male Wistar rats

Article

Author: Liow, Chun Hung ; Mohd Esa, Norhaizan ; Yaacob, Azhar ; Abu Saad, Hazizi

BACKGROUND & AIMS:

Testosterone, vital for reproductive health and muscle development, declines with age, increasing susceptibility to conditions like diabetes, obesity and sarcopenia. Conventional hormone therapy carries risks, including elevated prostate-specific antigens and prostate cancer risk, prompting exploration of safer options like intermittent fasting (IF) and physical training (PT) which potentially boost androgen in certain cases. However, their combined impacts on testosterone remain underexplored. This study aimed to assess the individual and combined effects of IF and PT on androgen and androgen receptor (AR) levels.

METHODS:

Forty male Wistar rats were divided into five groups (n = 8 each): negative control (NC) receiving food ad libitum without orchiectomized, positive control (PC) receiving daily testosterone enanthate injections, IF with 16/8 time-restricted feeding, PT with 1-h forced swimming sessions, and combined IF + PT. After 8 weeks, DHEA and testosterone levels, AR expression, gastrocnemius muscle histology, and body weight were assessed.

RESULTS:

In comparison to the NC group (429.40 ± 26.86 g), body weight in the IF (348.90 ± 15.94 g, PT (391.40 ± 16.35 g), and IF + PT groups, (360.90 ± 29.90 g) was significantly lowered (p < 0.05) after 8 weeks of study. The muscle fiber cross-sectional area in the IF (2968 μm²; IQR 1995-4053 μm²), PT (2956 μm²; IQR 2089-4371 μm²), and IF + PT groups, (3389 μm²; IQR 2260-4596 μm²) was significantly greater than the NC group (2508 μm²; IQR 1800-3567 μm². p < 0.05) after the study. DHEA levels significantly increased in the PT and IF + PT groups (375.01 ± 32.55 ng/μL and 420.00 ± 24.50 ng/μL, respectively) compared to the NC group (257.09 ± 67.79 ng/μL, p < 0.05). However, neither IF nor PT, alone or in combination, resulted in improvements in testosterone levels or AR expression in the gastrocnemius muscle. with testosterone levels remained unchanged.

CONCLUSION:

IF, PT, and IF + PT demonstrated potential effects on improving androgen levels, managing weight, and enhancing muscle growth, with IF + PT emerging as the most effective intervention. Despite these positive outcomes, the lack of impact on AR expression and testosterone levels suggests the need for further research to elucidate the underlying mechanisms and potential clinical applications for managing androgen deficiency through these interventions.

01 Feb 2025·TISSUE & CELL

NOX4 deficiency improves the impaired viability, inhibited the apoptosis and suppressed autophagy of DHEA-treated ovarian granulosa cells through inhibiting endoplasmic reticulum stress via inactivating PERK/ATF4 pathway

Article

Author: Wu, Lingyuan ; Xing, Xin ; Yu, Na

BACKGROUND:

PCOS is the most prevalent endocrine and metabolic problem in women of reproductive age. This current study was formulated to thoroughly expound the ovary-protecting effects of NOX4 deficiency in PCOS and probe into the intrinsic mechanisms underlying the protective effects of NOX4 deficiency against DHEA injury in ovarian GCs.

METHODS:

KGN cells were subjected to 20 nM DHEA for 48 h to establish PCOS cellular model. For loss-of-function experiments, KGN cells were transfected with si-NOX4. In addition, to investigate the biological roles of ERS and PERK/ATF4 pathway in the ovary-protecting effects of NOX4 deficiency in DHEA-treated ovarian GCs, KGN cells were pretreated with ERS agonist TM or PERK agonist CCT020312.

RESULTS:

NOX4 was highly expressed in DHEA-treated ovarian GCs. NOX4 deficiency improved the impaired viability, inhibited the apoptosis and suppressed autophagy of DHEA-treated ovarian GCs. Besides, NOX4 deficiency inactivated PERK/ATF4 pathway in DHEA-treated ovarian GCs. NOX4 deficiency repressed DHEA-induced ERS of ovarian GCs through inactivating PERK/ATF4 pathway. Pretreatment with ERS agonist TM or pretreatment with PERK agonist CCT020312 can both reduced the viability, promoted the apoptosis and strengthened autophagy of ovarian GCs, partially abolishing the ovary-protecting effects of NOX4 deficiency in DHEA-treated ovarian GCs. In general, NOX4 deficiency could improve the impaired viability, inhibited the apoptosis and suppressed autophagy of DHEA-treated ovarian GCs through repressing ERS depending on inactivation of PERK/ATF4 pathway.

CONCLUSION:

To conclude, downregulation of NOX4 could exert ovary-protecting effects in DHEA-induced PCOS cellular model through repressing ERS via inactivating PERK/ATF4 pathway.

7

News (Medical) associated with Prasterone

10 Sep 2024

·www.drugs.com

Review Weighs Treatments for Genitourinary Symptoms of Menopause

TUESDAY, Sept. 10, 2024 -- Vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), oral ospemifene, and vaginal moisturizers may be beneficial for some genitourinary symptoms of menopause (GSM), according to a review published online Sept. 10 in the Annals of Internal Medicine . Elisheva R. Danan, M.D., M.P.H., from the University of Minnesota in Minneapolis, and colleagues examined the effectiveness and harms of vaginal estrogen, nonestrogen hormone therapies, and vaginal moisturizers for treatment of GSM in a systematic review of randomized controlled trials (RCTs). A total of 46 RCTs assessing vaginal estrogen, nonestrogen hormones, vaginal moisturizers, or multiple interventions were identified from 11,993 citations. The researchers found that vaginal estrogen may improve vulvovaginal dryness, dyspareunia , the most bothersome symptom, and treatment satisfaction compared with placebo or no treatment. Vaginal DHEA may improve dryness, dyspareunia, and distress, bother, or interference from genitourinary symptoms compared with placebo; oral ospemifene may improve dryness, dyspareunia, and treatment satisfaction; and dryness may also be improved by vaginal moisturizers (all low certainty of evidence [COE]). No benefit or uncertain effects (low and very low COE, respectively) may be provided by vaginal testosterone, systemic DHEA, vaginal oxytocin, and oral raloxifene or bazedoxifene. Reporting was limited by studies of short duration that were insufficiently powered to assess infrequent serious harms. "Future studies would be strengthened by standard definitions of symptoms and uniform diagnostic criteria for GSM, a common set of validated outcome measures and reporting standards, and attention to clinically relevant patient populations and intervention comparisons," the authors write.

Clinical Result

19 Jul 2024

·www.outsourcing-pharma.com

Avista and Hamilton Lane Join Forces to Propel Growth and Innovation at Cosette Pharmaceuticals

The companies will jointly control Cosette, with a focus on accelerating innovation and growth. Since Avista's initial investment in Cosette in December 2018, Cosette has launched new products through research and development efforts, acquisitions, and licensing deals. This includes the acquisition of Ambien and Ambien CR in the United States from Sanofi US. The company reports that these initiatives have led to significant EBITDA growth and free cash flow generation, positioning Cosette for future opportunities. Apurva Saraf, president and CEO of Cosette, said: “This partnership is a testament to the remarkable transformation our business has achieved over the past four years, driven by an unwavering commitment to strategic business development and operational excellence. I am immensely proud of the entire Cosette team for their dedication in delivering this robust growth. “We have successfully diversified our portfolio with branded products such as Clomid, Ambien, and Benicar, along with innovative, patent-protected drugs like Vyleesi and Intrarosa. With our strong R&D and business development pipeline, we are well positioned to drive substantial growth in partnership with Avista and Hamilton Lane." Financial strength and future opportunities for Cosette Pharmaceuticals The companies indicate that this transaction will enhance Cosette's balance sheet and support growth through investments in R&D and strategic acquisitions. The goal is to build a durable, high-growth, branded pharmaceutical company. As part of the transaction, Cosette has also secured a new term loan financing with Hayfin Capital Management and a new revolving credit facility provided by UBS Investment Bank, Capital One, National Association, and Santander Corporate & Investment Bank, who acted as joint lead arrangers and joint bookrunners for the financing. googletag.cmd.push(function () { googletag.display('text-ad1'); }); David Burgstahler, managing partner and CEO of Avista, added: “We value Avista's long-term relationship with Hamilton Lane and look forward to collaborating with them as a strategic partner to drive growth and value at Cosette. Our collective expertise will prove invaluable as Cosette evaluates larger M&A opportunities as part of the company's growth strategy.” Cosette Pharmaceuticals has made significant contributions to the pharmaceutical industry, particularly in the realm of specialty pharmaceuticals. The company has a strong focus on developing and commercializing branded and generic products that address unmet medical needs. With a diverse portfolio that includes notable products, Cosette has demonstrated a commitment to innovation and patient care. It says its strategic approach to research and development, coupled with targeted acquisitions and licensing deals, has enabled them to introduce groundbreaking therapies and expand their market presence, positively impacting patient outcomes and advancing healthcare solutions.

AcquisitionLicense out/in

08 Apr 2024

·www.prnewswire.com

Premium Jane Introduces Innovative Keto Product Line to Enhance Ketogenic Diet Experience

SCOTTSDALE, Ariz., April 8, 2024 /PRNewswire/ -- Premium Jane, a household name in the health supplements industry for nearly a decade, has unveiled a line of new products that are designed to complement and accelerate the benefits of a ketogenic diet. The "keto" diet, known for its emphasis on low-carb/high-fat calorie intake, has surged in popularity recently for its ability to help rapidly shed pounds, increase energy levels, and sharpen mental focus and acuity. After years of researching how to optimize this diet, Premium Jane has developed a range of products that are engineered to speed up the results of keto, as well as maintain the effects of the ketogenic state. The cornerstone of Premium Jane's new Keto line is a once-a-day fiber supplement formulated with inulin and chicory root - two crucial (but often overlooked) components of the ketogenic diet. Inulin is a type of soluble plant fiber that bypasses much of the digestive system until it reaches the colon. There, it serves as a prebiotic fiber and nourishes beneficial bacteria (such as Bifidobacteria and Lactobacilli) in the gut. By stimulating the growth of beneficial bacteria, inulin helps maintain a healthy balance of gut microflora. This is essential for balanced digestion, immune function, mental sharpness, and a whole lot more. Another key function of the product is its potential to help slow down emptying of the stomach, thereby enhancing feelings of fullness and boosting weight loss efforts. "We are beyond thrilled to unveil our new Keto product line," says Premium Jane CEO Jeff Yauck. "The ketogenic state isn't just a trend; we, along with research experts across the world, believe it really is the future of health and weight loss." In addition to the inulin fiber supplement, Premium Jane has also released a line of dietary capsules containing 7-keto DHEA - a naturally occurring metabolite of dehydroepiandrosterone (DHEA). 7-keto DHEA has been studied for its potential to enhance metabolic rate and support fat loss, making it an ideal complement to a ketogenic lifestyle. Additionally, Premium Jane is offering Keto BHB gummies, which contain a unique blend of calcium, magnesium, and sodium beta-hydroxybutyrate (BHB). Research is showing BHB to have profound effects on mental clarity, sustained energy, and accelerated fat burning. To place an order or to learn more about the new Keto product range from Premium Jane, visit the company's official website at . Contact: Premium Jane [email protected] SOURCE Premium Jane

100 Deals associated with Prasterone

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External Link

KEGG	Wiki	ATC	Drug Bank
D08409	Prasterone	G03XX01 A14AA07	DB01708

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hot Flashes	CA	Endoceutics, Inc.	06 Nov 2019
Osteoporosis	CA	Endoceutics, Inc.	06 Nov 2019
Dyspareunia	US	Millicent Oy	16 Nov 2016
Vulvovaginal atrophy	US	Millicent Oy	16 Nov 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Genitourinary Syndrome of Menopause	Phase 3	US	AMAG Pharmaceuticals, Inc.	01 May 2020
Menopausal symptoms	Phase 3	US	AMAG Pharmaceuticals, Inc.	01 May 2020
postmenopausal disorder	Phase 3	US	AMAG Pharmaceuticals, Inc.	01 May 2020
Urinary Tract Infections	Phase 3	US	AMAG Pharmaceuticals, Inc.	01 May 2020
Breast Cancer	Phase 3	-	Endoceutics, Inc.	06 Nov 2018
Breast Cancer	Phase 3	-	AMAG Pharmaceuticals, Inc.	06 Nov 2018
Crohn Disease	Phase 2	US	Inflabloc Pharmaceuticals, Inc.	01 Jan 2005
Crohn Disease	Phase 2	CA	Inflabloc Pharmaceuticals, Inc.	01 Jan 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03491007 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	5	PBO (Placebo)	lvxrmncuqz(wxbvuhrxdt) = alwprfouem jhdmnqpufy (zpbrtjhacj, ifnhgaooiu - dzritcytbh) View more	-	06 May 2023
				DHEA (DHEA)	kgwzoowges(usnslbfxyw) = qwubmtswpi twkqsnuuxl (vuibemuihb, kjsmnojjxy - hqfkshjkqu) View more
NCT01256671 (CTgov)	Phase 3	Vulvovaginal atrophy	530	DHEA (prasterone)	apxwxtxsgn(aemyowiftu) = fihegcwbks zabtrohjnq (bjigbazsjh, lwylejtkte - anrvfwqdna) View more	-	18 Oct 2017
NCT01376349 (CTgov)	Phase 3	Vaginal Discharge \| Female Genital Neoplasms \| Breast Cancer	464	prasterone (Arm I Low Dose DHEA)	upgtwkuekw(apoadyaakx) = etevxovvrq rfpwwgfavl (idwpzosyiw, qtcunnyhod - jsfpcfyaxl)	-	25 Aug 2017
				prasterone (Arm II High Dose DHEA)	upgtwkuekw(apoadyaakx) = csodyalfxi rfpwwgfavl (idwpzosyiw, rtezaptxmq - vaaafdwpcg)
NCT01358760 (CTgov)	Phase 3	Vulvovaginal atrophy	450	Placebo (Placebo)	kcpbboxapr(pdtnwouuts) = vbirbehnbp jmlyjnlwng (xcgqllpjuo, nlkluhfmko - rulyozmays) View more	-	12 Jun 2017
				DHEA (0.25% DHEA)	kcpbboxapr(pdtnwouuts) = yogwtffvzc jmlyjnlwng (xcgqllpjuo, mlsoupwsxm - cjjavtoxqw) View more
NCT02013544 (CTgov)	Phase 3	Vulvovaginal atrophy	558	Placebo	ivivaxbeec(ccgaxbbfdg) = svuhebjmdi iivzjgalzk (swjszjraxr, rdxkgrqnmn - yxiyopfbga) View more	-	01 Jun 2017
NCT01846442 (CTgov)	Phase 3	Vulvovaginal atrophy	218	Placebo (Placebo)	wybwwxsxyp(ynidrlixae) = kftxpxvqhl fjclniahmn (ymlclrhkid, inicuaoggv - eszccpmoin) View more	-	28 Apr 2017
				DHEA (0.25%) (0.25% DHEA)	wybwwxsxyp(ynidrlixae) = koprwacmze fjclniahmn (ymlclrhkid, ssvkbmswzz - kqbqpguihn) View more
NCT01256684 (CTgov)	Phase 3	Vulvovaginal atrophy	255	Placebo (Placebo)	oxvpejxvit(kmyafjiroa) = eicbtkjxla jsznotvgrf (mylbtzjjec, aszhswjype - zxkgyfvoba) View more	-	25 Apr 2017
				DHEA (0.25% DHEA)	oxvpejxvit(kmyafjiroa) = omlnzcumny jsznotvgrf (mylbtzjjec, krygsbubrd - cteeafsdik) View more
NCT01256671 (Pubmed \| Maturitas) Manual	Phase 3	Vulvovaginal atrophy	521	Prasterone	hhvhsvyiev(nygdghlylt) = similar improvement results on vaginal dryness and irritation/itching. Highly significant beneficial effects (p<0.0001 versus baseline for all) at gynecological examination on vaginal secretions, color, epithelial integrity and epithelial surface thickness wvremkpkjq (kpnmedibkt ) View more	Positive	01 May 2015
NCT02150330 (Pubmed \| Taiwan J Obstet Gynecol)	Phase 3	Ovarian Diseases	10	DHEA supplementation	fwwzkaslvs(xvhnxgtkiz) = sbwngdzoof stnmupuwdj (clstozedfo )	-	01 Apr 2015
NCT01358760 (Pubmed \| Climacteric) Manual	Phase 3	Vulvovaginal atrophy	-	dehydroepiandrosterone	bmtavoupme(tnxmjymlcx) = In parallel, the statistical significance over placebo (p value) on MBS vaginal dryness at 6 weeks was 0.09 followed by an increase to 0.198 at 12 weeks. uxovdweyfp (qjmttekpch ) View more	Negative	01 Jan 2015
				Placebo