International Menopause Society

Positive topline results from Phase III long-term study OASIS 3 support submissions for marketing authorization for Bayer’s elinzanetant

Retrieved on: 
Tuesday, March 19, 2024
Health, Fitness & Nutrition, Clinical Trials, Research, Pharmaceutical, Science, International Menopause Society, VMS, Menopause, OASIS, Executive Committee, Imperial College London, Woman, Hot, Safety, Elinzanetant, Phase, Marketing, Pharmaceutical industry

Bayer today announced positive topline results of the Phase III study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo.

Key Points: 
  • Bayer today announced positive topline results of the Phase III study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo.
  • The long-term safety profile observed over 52 weeks in the OASIS 3 study is overall consistent with previously conducted studies and published data1,2 on elinzanetant.
  • “OASIS 3 was designed to address the important question of the long-term profile of elinzanetant.
  • “These results, coupled with the recent announcement of topline data for OASIS 1 and OASIS 2, strengthen our confidence in the proposed efficacy and safety of elinzanetant as a potential novel non-hormonal solution for women experiencing menopause-related symptoms.”
    OASIS 3 (NCT05030584) is the third Phase III study in the OASIS clinical development program with positive topline results.

FertilityIQ Rebrands as Inflection to Help Employees During Life’s Pivotal Moments

Retrieved on: 
Tuesday, January 23, 2024
Health, Health Technology, General Health, Vitamins, Supplements, Pharmaceutical, Biotechnology, Woman, Stanford University, Patient, MD, Inflection, International Menopause Society, Insurance, Harvard University, Menopause, University of Oxford, McGill University, Doctor of Philosophy, Spouse, Education, Management

FertilityIQ, the world’s largest educational platform for menopause and family-building, announces its rebranding as Inflection .

Key Points: 
  • FertilityIQ, the world’s largest educational platform for menopause and family-building, announces its rebranding as Inflection .
  • According to International Menopause Society chair Dr. Nick Panay, “Great education is critical to helping women through menopause.
  • Inflection clients include over 30% of “The Best Places to Work” with a perfect 100% large client retention rate.
  • Inflection’s enterprise clients experience double-digit utilization rates, easy implementation (Inflection takes no PHI), and often can have their insurance carrier pay all fees.

FertilityIQ Announces First-of-Its-Kind Menopause Education Offering & Record Uptake Amongst Employers and Patients

Retrieved on: 
Wednesday, November 29, 2023
LGBTQ+, Mental Health, Health, Consumer, Women, Other Health, Woman, Osteoporosis, Brain, Hot, Fertility, Gynaecology, International Menopause Society, Irritability, Endocrinology, Menopause, Psychology, Patient, North American Menopause Society, University, Harvard Medical School, Spouse, Imperial College London, Utrecht University, Quality of life, Education, Nursing

FertilityIQ, the global leader for fertility and family-building digital education, today announced the first-of-its-kind menopause education offering.

Key Points: 
  • FertilityIQ, the global leader for fertility and family-building digital education, today announced the first-of-its-kind menopause education offering.
  • The complete educational offering for women, patients, and employees offers crucial information for those going through perimenopause and the menopause transition.
  • "Great education is critical to helping women through menopause.
  • FertilityIQ's global courses are a valuable resource for patients, spouses, and employers," says Dr. Nick Panay, the current president of the International Menopause Society and past Chair of the British Menopause Society.

Dr. Wolff's Vagisan Introduces Hormone-Free Moisturising Cream and Moisturising Cremolum, Clinically Proven to Soothe Vaginal Dryness

Retrieved on: 
Thursday, October 19, 2023
Cream, Lubrication, Vaginal discharge, Ageing, Menopause, Family, Vagina, Itch, Skin, Combustion, Friends, Climacteric, AIP, Quality of life, Lipid, International Menopause Society, Risk, Moisturizer, Dry, Woman, Safety, Elasticity, Personal lubricant, Pain, Douche, Kong, Birth control

Hong Kong SAR, China--(Newsfile Corp. - October 19, 2023) - Dr. Wolff's Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum for women troubled by vaginal dryness while experiencing menopause.

Key Points: 
  • Hong Kong SAR, China--(Newsfile Corp. - October 19, 2023) - Dr. Wolff's Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum for women troubled by vaginal dryness while experiencing menopause.
  • Vaginal secretions gradually decrease as a woman ages, resulting in decreased lubrication and elasticity of the vaginal tissue.
  • This can result in vaginal dryness and associated symptoms such as dryness, itching, burning, and pain3.
  • Vaginal hormone-free moisturising cream is not inferior to an estriol cream for treating symptoms of vulvovaginal atrophy: Prospective, randomised study.

Dr. Wolff Group: Dr. Wolff’s Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum, clinically proven to soothe vaginal dryness

Retrieved on: 
Thursday, October 26, 2023
Cream, Lubrication, Vaginal discharge, Ageing, Menopause, Family, Itch, Skin, Combustion, Vagina, Friends, Climacteric, AIP, Quality of life, Lipid, International Menopause Society, Risk, Moisturizer, Dry, Woman, Safety, Elasticity, SAR, Personal lubricant, Pain, Douche, Birth control, Cosmetics

Dr. Wolff Group: Dr. Wolff’s Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum, clinically proven to soothe vaginal dryness

Key Points: 
  • Dr. Wolff Group: Dr. Wolff’s Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum, clinically proven to soothe vaginal dryness
    The issuer is solely responsible for the content of this announcement.
  • Dr. Wolff’s Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum, clinically proven to soothe vaginal dryness
    HONG KONG SAR - Media OutReach - 18 October 2023 - Many woman experiencing menopause are troubled by vaginal dryness.
  • This can result in vaginal dryness and associated symptoms such as dryness, itching, burning, and pain3.
  • Vaginal hormone-free moisturising cream is not inferior to an estriol cream for treating symptoms of vulvovaginal atrophy: Prospective, randomised study.

Sermonix Pharmaceuticals Announces Results of ELAINE-1 Exploratory Analysis Evaluating Effect of Patient Characteristics on Baseline Genitourinary Symptoms

Retrieved on: 
Monday, October 2, 2023
North American Menopause Society, Therapy, Progression-free survival, International Menopause Society, ESR1, ESMO, Life, Fulvestrant, Quality of life, Woman, NAMS, Mutation, Oncology, European Society for Medical Oncology, Goldfarb, Eli Lilly, Congress, Patient, Memorial Sloan Kettering Cancer Center, Annual general meeting, Diagnosis, Poster, AI, Menopause, Tamoxifen, Breast cancer, Birth control, Pharmaceutical industry, COLUMBUS

Prior adjuvant tamoxifen was associated with more severe vaginal/vulvar symptoms, as was a longer total duration of AI use in both adjuvant and metastatic settings.

Key Points: 
  • Prior adjuvant tamoxifen was associated with more severe vaginal/vulvar symptoms, as was a longer total duration of AI use in both adjuvant and metastatic settings.
  • Duration of prior AI in the adjuvant setting alone did not impact baseline vaginal or vulvar symptoms.
  • “As women are living longer with ER+ metastatic disease, it is extremely important to treat their symptoms to improve quality of life.
  • A secondary exploratory analysis showed numeric improvements in vaginal/vulvar symptoms with lasofoxifene versus fulvestrant (Goldfarb et al., 2023, ISSWSH).

Daré Bioscience Announces Publication of Phase 1/2 Pharmacokinetic, Safety and Pharmacodynamic Data for DARE-VVA1 - a Potential New Hormone-Free Treatment for Vulvovaginal Atrophy - in Climacteric, the Journal of the International Menopause Society

Retrieved on: 
Friday, June 9, 2023
Survivor, Prevalence, Journal, Vaginal discharge, International Menopause Society, Pharmacokinetics, Woman, History, Trial of the century, Hormone, HR, Investigational New Drug, MD, Patient, Article, SAN, IND, Tamoxifen, Safety, Breast cancer, VVA, Pharmaceutical industry, Birth control, Climacteric

The journal article, “Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy,” was published online and will appear in Climacteric, the official journal of the International Menopause Society.

Key Points: 
  • The journal article, “Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy,” was published online and will appear in Climacteric, the official journal of the International Menopause Society.
  • The randomized, double-blind, placebo-controlled study was designed to evaluate the pharmacokinetics, safety and pharmacodynamics of DARE-VVA1 in postmenopausal participants with moderate to severe VVA.
  • “The unmet need for an effective non-hormonal treatment for VVA caused by anti-cancer endocrine therapy in patients diagnosed with HR+ breast cancer is undeniable.
  • Daré is conducting activities to support submission of an Investigational New Drug (IND) application and initiation of a Phase 2 clinical study of DARE-VVA1.

Entera Bio Announces Q1 2023 Financial Results and Corporate Updates

Retrieved on: 
Friday, May 5, 2023
Parenteral nutrition, PK, Insurance, Amgen, Mineral, Endocrinology, FNIH, Institutional review board, North American Menopause Society, D&O, Osteoporosis, Hypoparathyroidism, Woman, Global Research Collaboration for Infectious Disease Preparedness, BMD, Entera, Bangladesh Technical Education Board, Short bowel syndrome, PTH, SABRE, Tablet, Patient, IRB, Canadian International Council, Ecosystem, R, Research, FDA, Therapy, Three Months, International Menopause Society, Peptide, Pharmaceutical industry, Cryptocurrency, D

JERUSALEM, May 05, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, today reported corporate updates and financial results for the first quarter ended March 31, 2023.

Key Points: 
  • JERUSALEM, May 05, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, today reported corporate updates and financial results for the first quarter ended March 31, 2023.
  • Entera previously reported that it will continue discussions with the agency until final guidance is received on the proposed statistical evaluation of its primary endpoint.
  • This initiative builds on prior PK and Phase 2 results of an earlier generation of EB612 in hypoparathyroidism patients.
  • Entera’s operating loss was $2.2 million for quarter ended March 31, 2023, as compared to $3.8 million for the quarter ended March 31, 2022.

Menopause Luminary, Dr. Steven R. Goldstein, Joins Entera’s Clinical and Scientific Advisory Board

Retrieved on: 
Wednesday, April 26, 2023
Endocrinology, Obstetrics, North American Menopause Society, Osteoporosis, Hip, University School, International Menopause Society, Ageing, Woman, Coronavirus Scientific Advisory Board, NAMS, Research, PTH, MD, CSAB, New York University Grossman School of Medicine, Fracture, Menopause, Gynaecology, Birth control, Entera

Gynecologists remain primary care for the millions of women in or post-menopause globally and the importance of actively managing bone health is paramount to their well-being.

Key Points: 
  • Gynecologists remain primary care for the millions of women in or post-menopause globally and the importance of actively managing bone health is paramount to their well-being.
  • Unfortunately, much of the undertreatment of osteoporosis and the missed opportunity to reduce fractures stems from lack of oral anabolic agents.
  • The fact that such agents require injection (either daily or monthly) causes large numbers of women to go under treated.
  • An oral PTH analogue would be extremely useful in helping so many of these women,” stated Dr. Steven R. Goldstein.

Daré Bioscience Announces Publication of Positive Safety and Acceptability Data from Phase 1 Clinical Trial that Support the Potential of DARE-HRT1 Intravaginal Ring as a New Menopausal Hormone Therapy

Retrieved on: 
Tuesday, April 18, 2023
IVR, VMS, International Menopause Society, P4, Pharmacokinetics, Climacteric, Woman, NAMS, Estradiol, Doctor of Philosophy, Harvard Medical School, Massachusetts Institute of Technology, SAN, Menopause, Hospital, Progesterone, FDA, Massachusetts General Hospital, North American Menopause Society, Food, Safety, Pharmaceutical industry, Birth control, Medical device

SAN DIEGO, April 18, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that Climacteric, the official journal of the International Menopause Society, published safety and acceptability results from a Phase 1 clinical trial of DARE-HRT1, an investigational ethylene vinyl acetate copolymer intravaginal ring (IVR) designed to release bio-identical 17β-estradiol (E2) and progesterone (P4) over 28 days. DARE-HRT1 is being developed for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause in women with intact uteri.

Key Points: 
  • DARE-HRT1 is being developed for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause in women with intact uteri.
  • Hormone therapy is used to treat VMS and genitourinary syndrome associated with menopause.
  • DARE-HRT1 has the potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format.
  • The primary objective of the study was to assess the pharmacokinetics from the two dosage strengths of the DARE-HRT1 IVRs.