Prestara (prasterone) / GSK - LARVOL DELTA

ROSA: Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain (clinicaltrials.gov) - P3; N=50; Recruiting; Sponsor: Dr. Santiago Palacios

Clinical • New P3 trial • Pain • Vaginal Atrophy

Serum untargeted metabolomics delineates the metabolic status in different subtypes of non-alcoholic fatty liver disease. (PubMed, J Pharm Biomed Anal) - "This study suggested that significant metabolic differences existed among subtypes of NAFLD, and our model might be useful to distinguish patients with NAFLD. These findings may lay a foundation for the detection and treatment of NAFLD subtypes."

Journal • Hepatology • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Obesity

Genitourinary Menopause Syndrome. CNGOF and GEMVi clinical practice guidelines (PubMed, Gynecol Obstet Fertil Senol) - "SGUM is a common symptom that can affect the quality of life of postmenopausal women. A treatment should be systematically proposed. Local non-hormonal treatment may be offered in all women. Local low-dose estrogen therapy and Prasterone has shown an interest in the management of symptoms. In women before a history of breast cancer, local non-hormonal treatment should be offered first-line. The safety of low-dose local estrogen therapy and Prasterone cannot be established at this time. Other alternatives exist but are not currently recommended in France due to lack of data."

Clinical • Clinical guideline • Breast Cancer • Oncology • Pain • Solid Tumor • Urinary Incontinence • Urology • Vaginal Atrophy

Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: University of Arkansas; Trial completion date: Aug 2022 ➔ Aug 2023; Initiation date: Dec 2020 ➔ May 2021; Trial primary completion date: Aug 2021 ➔ Aug 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Vaginal Atrophy

Determination of anabolic androgenic steroids in dietary supplements and external drugs by magnetic solid-phase extraction combined with high-performance liquid chromatography-tandem mass spectrometry. (PubMed, J Sep Sci) - "The developed method was then successfully applied for the determination of 17 anabolic androgenic steroids in real samples, and dehydroepiandrosterone (prasterone) was detected in a commercially available external drug. Under the optimal conditions, the limits of detection were in the range of 0.001-0.02 ?g/L, with relative standard deviations of 5.52%-11.6% (n = 7) for all the steroids, and the enrichment factors were in the range of 20.0-24.8. The developed method was then successfully applied for the determination of 17 anabolic androgenic steroids in real samples, and dehydroepiandrosterone (prasterone) was detected in a commercially available external drug."

Journal • Cardiovascular • CNS Disorders • Congestive Heart Failure • Heart Failure • Mood Disorders • Psychiatry

VAGINAL PRASTERONE in the Treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY) (clinicaltrials.gov) - P4; N=10; Recruiting; Sponsor: Hospital Clinic of Barcelona

Clinical • New P4 trial • Breast Cancer • Oncology • Solid Tumor • Vaginal Atrophy

[VIRTUAL] Prasterone: a dual approach to the management of postmenopausal Vulvar and Vaginal Atrophy (VVA) (sponsored by Theramex) (ISGE-I 2020) - No abstract available

Vaginal Atrophy

[VIRTUAL] Should we talk about cosmetic gynecology or it is regenerative gynecology (ISGE-I 2020) - "For women with vulvovaginal symptoms, first-line therapies include long-acting vaginal moisturizers, low-dose vaginal estrogens, or intravaginal prasterone. Emerging treatments include ospemifene, a SERM with specific vaginal function and heat energy based treatments, such as vulvo-vaginal laser, which are being studied in this area. All the different treatments decrease vaginal pH, some of them has properties like preservation of water equilibrium; others increase collagen fivers, neovascularization, gross vaginal mucosae and vaginal lactobacilli. Given the mechanisms of action of the different treatments and the definitions of the two concepts, we can conclude that we must talk about regenerative gynecology when we talk about VVA treatments."

Aesthetic Medicine • Gynecology • Vaginal Atrophy

[VIRTUAL] Absence of detrimental impact of treating women diagnosed with vulvovaginal atrophy (VVA) with intravaginal prasterone (DHEA) on the risk of breast cancer: A retrospective matched cohort study. (ISGE-I 2020) - "Conclusions While the results are based on retrospective data, they nonetheless highlight the absence of a manifest detrimental impact of the use of intravaginal prasterone on neither the incidence nor the recurrence of BrCa in women with VVA, but also the growing use of intravaginal prasterone in US BrCa patients, thus permitting the inclusion of almost three thousand patients with a history of BrCa in that study. Sensitivity analyses stratifying on cumulative days of supply also showed an absence of detrimental effect."

Retrospective data • Breast Cancer • Dyslipidemia • Genetic Disorders • Obesity • Oncology • Solid Tumor • Vaginal Atrophy • BRCA

[VIRTUAL] Vulvar vestibular effects of prasterone: a prospective vulvoscopic pilot study (ISGE-I 2020) - "Conclusions Prasterone ovule daily for 60 days showed improvement in physical examination findings in this prospective study of postmenopausal women with GSM symptoms, as documented on vulvoscopic photography. These changes were consistent with improvements in subject-reported pain and sexual function."

Clinical • Pain • Vaginal Atrophy • Women's Health

[VIRTUAL] Overview of clinical data with prasterone (ISGE-I 2020) - No abstract available

Clinical data

[VIRTUAL] DHEA and sexuality in elderly people (ISGE-I 2020) - "Prasterone is the only locally acting DHEA therapy approved as a vaginal pessary for the treatment of VVA in postmenopausal women having moderate to severe symptoms. Prasterone provides improvements in symptoms from 2 weeks and has demonstrated an improvement in pain symptoms during sexual activity, increase in desire, arousal, sexual satisfaction and orgasm with a manageable safety profile."

Clinical • Aesthetic Medicine • Pain • Vaginal Atrophy

[VIRTUAL] Evaluation of the effect of Prasterone (DHEA) in the treatment of hypoactive sexual desire and its impact on different metabolic and anthropometric parameters in postmenopausal women; one year follow up (ISGE-I 2020) - "Conclusion. The daily administration of 50 mg of DHEA orally for 12 months significantly improved the IFSF, without affecting the metabolic profile, the body composition and kepping bone mineral density and muscular mass."

Clinical

[VIRTUAL] Prevalence of Urinary Tract Infections in Women with Genitourinary Syndrome of Menopause and the Impact of Vaginal Prasterone on Urinary Tract Infections. (ISGE-I 2020) - "Women newly diagnosed with GSM have a higher rate of UTIs compared to women without GSM. Results also suggest that the use of prasterone in women diagnosed with GSM may reduce the recurrence of UTIs."

Clinical • Diabetes • Infectious Disease • Metabolic Disorders • Nephrology

[VIRTUAL] HRT in cancer survivors (ISGE-I 2020) - "Breast cancer survivors should not generally be treated with either systemic estrogen-based MHT or tibolone. The concern is a risk of recurrence. There are no data regarding the use of ospemifene or prasterone."

Breast Cancer • Endometrial Cancer • Germ Cell Tumors • Gynecologic Cancers • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • PGR

[VIRTUAL] Prasterone in clinical practice: case studies (ISGE-I 2020) - No abstract available

Clinical

[VIRTUAL] Intravaginal prasterone (DHEA) does not increase serum levels of estrogens in women treated with an aromatase inhibitor for breast cancer – results from a pilot study. (ISGE-I 2020) - "Conclusion These data show that the serum levels of estrogens remain undetectable or very low following the administration of a single intravaginal dose of 6.5 mg of prasterone in women taking an aromatase inhibitor. Although the number of patients is very limited, these results suggest that intravaginal administration of prasterone may be a safe treatment option for VVA in women with a history of breast cancer taking aromatase inhibitors."

Clinical • Breast Cancer • Oncology • Solid Tumor • Vaginal Atrophy

Drugs for menopausal symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: University of Arkansas; Initiation date: Aug 2020 ➔ Dec 2020

Clinical • Trial initiation date • Breast Cancer • Oncology • Solid Tumor • Vaginal Atrophy

Dehydroepiandrosterone for depressive symptoms: A systematic review and meta-analysis of randomized controlled trials. (PubMed, J Neurosci Res) - "In conclusion, DHEA was associated with a beneficial effect on depressive symptoms compared to placebo. However, these results should be viewed with caution, since the quality of evidence for this outcome was considered very low according to the GRADE criteria."

Journal • Retrospective data • Review • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Psychiatry

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: EndoCeutics Inc.; Trial completion date: Mar 2021 ➔ Dec 2019; Trial primary completion date: Dec 2020 ➔ Aug 2019

Clinical • Trial completion date • Trial primary completion date • Sexual Disorders

Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: EndoCeutics Inc.; Trial completion date: Jun 2021 ➔ Dec 2019; Trial primary completion date: Mar 2021 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Vaginal Atrophy

Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: University of Arkansas

Clinical • New P2 trial • Breast Cancer • Oncology • Solid Tumor • Vaginal Atrophy

Managing Genitourinary Syndrome of Menopause in Breast Cancer Survivors Receiving Endocrine Therapy. (PubMed, J Oncol Pract) - "In severe or refractory GSM, after discussing risks and benefits of vaginal hormonal therapy, the low-dose 10-μg estradiol-releasing intravaginal tablet or lower-dose 4 μg estrogen vaginal insert and intravaginal dehydroepiandrosterone (prasterone) are options for treatment, because studies show minimal elevation in serum estradiol levels and significant improvement in symptoms. The decision to offer vaginal estrogen therapy must be individualized and made jointly with the patient and her oncologist."

Journal • Breast Cancer • Oncology • Solid Tumor

Effective Prevention of Recurrent UTIs with Vaginal Estrogen: Pearls for a Urological Approach to Genitourinary Syndrome of Menopause. (PubMed, Urology) - "Overall, multiple randomized clinical trials have successfully been completed to show the efficacy of local estrogen preparations for the treatment of rUTIs. This high yield review provides a framework for assessing GSM, prescribing recommendations for local vaginal hormone preparations, and a summary of the substantial evidence supporting the new 2019 AUA/CUA/SUFU Guidance for local vaginal estrogen use for rUTI."

Journal • Nephrology