Vulvar and Vaginal Atrophy
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CLINICAL_TRIALS trial_result · 2025-12-31Clinical Trial Update: Regenerative Treatment of Female Genital Atrophy [Phase 1, Phase 2]
This entry reports the completion of Phase 1/Phase 2 trials evaluating a regenerative treatment for vulvar and vaginal atrophy.
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CLINICAL_TRIALS trial_result · 2025-09-15Clinical Trial Update: Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders [Phase 4]
Phase 4 trial evaluating the effects of ospemifene on brain activation patterns in women with female sexual interest/arousal disorder. The s…
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FDA label_change · 2025-04-22FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for Premarin Vaginal (conjugated estrogens) to update the product's labeling under Wyeth Pharmaceuti…
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CLINICAL_TRIALS research · 2025-02-14Clinical Trial Update: Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment [NA]
This clinical trial evaluates adding a vaginal dilator to usual treatment for vulvar and vaginal atrophy/genitourinary syndrome of menopause…
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EMA approval · 2024-11-25EMA Authorised: Senshio (ospemifene) — Shionogi B.V.
The EMA authorised Senshio (ospemifene) for postmenopausal vulvar and vaginal atrophy. Marketing authorization was granted to Shionogi B.V. …
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CLINICAL_TRIALS trial_result · 2024-10-15Clinical Trial Update: A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women [Phase 1]
Phase 1 open-label study to evaluate the pharmacokinetics and safety of DARE-HRT1 in healthy postmenopausal women has completed and results …
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FDA approval · 2024-08-02FDA Approved: LYLLANA — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for LYLLANA (estradiol) submitted by Amneal Pharmaceuticals LLC.
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CLINICAL_TRIALS trial_result · 2024-04-12Clinical Trial Update: Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy [Phase 3]
A Phase 3 clinical trial comparing Estradiol Vaginal Inserts 4 mcg to IMVEXXY for the treatment of dyspareunia in women with vulvar and vagi…
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FDA approval · 2024-02-16FDA Approved: ESTRADIOL VAGINAL — Supplemental Application (Encube Ethicals, Inc.)
FDA approved a supplemental application for ESTRADIOL VAGINAL (Encube Ethicals, Inc.), updating labeling for the product under ANDA 209767.
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FDA approval · 2024-02-15FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)
FDA approves a supplemental application for OSPHENA (ospemifene) submitted by Duchesnay USA, Inc.
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FDA approval · 2023-11-14FDA Approved: ESTRADIOL — Original Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved an Estradiol generic product from Padagis Israel Pharmaceuticals Ltd under an Original Application, enabling its use for estrog…
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FDA approval · 2023-08-24FDA Approved: ESTRADIOL — Original Application (NorthStar Rx LLC)
FDA approved NorthStar Rx LLC's Estradiol as an original-application generic product (ANDA217610).
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FDA label_change · 2022-09-29FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)
The FDA approved a supplemental application for Vagifem (estradiol) from Novo Nordisk to update the product labeling.
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CLINICAL_TRIALS trial_result · 2022-09-13Clinical Trial Update: Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy [Phase 4]
Phase 4 clinical trial comparing two doses of Estrogel to placebo in postmenopausal symptoms, assessing vasomotor symptoms and vulvar/vagina…
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FDA approval · 2022-07-27FDA Approved: ESTRING — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for ESTRING (estradiol vaginal ring) from Pfizer Laboratories Div Pfizer Inc. The approval updates t…
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FDA approval · 2021-11-30FDA Approved: ESTROGEL — Supplemental Application (ASCEND Therapeutics US, LLC)
FDA approved a supplemental application for ESTROGEL (estradiol) from ASCEND Therapeutics US, LLC, expanding the product's labeling for meno…
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CLINICAL_TRIALS trial_result · 2020-08-11Clinical Trial Update: Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy [Phase 3]
Phase 3 trial comparing two treatments for vulvar and vaginal atrophy has completed with posted results.
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FDA approval · 2019-02-05FDA Approved: DOTTI — Original Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal's original application for DOTTI, a generic estradiol product, expanding availability of estrogen replacement therap…
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FDA approval · 2018-01-22FDA Approved: ESTRADIOL VAGINAL — Original Application (AvKARE)
FDA approved AvKARE's Estradiol Vaginal as an Original Application (ANDA) for a generic estradiol vaginal product. It is indicated for the t…
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CLINICAL_TRIALS trial_result · 2017-11-21Clinical Trial Update: Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects [NA]
A prospective, open-label, single-center, non-comparative study evaluated the Pixel CO2 Laser System (FemiLift) for vulvar and vaginal atrop…
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CLINICAL_TRIALS trial_result · 2017-11-14Clinical Trial Update: To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women. [Phase 3]
A Phase 3 trial evaluating generic estradiol 10 mcg vaginal tablets for vulvar and vaginal atrophy in postmenopausal women has completed.
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FDA approval · 2017-11-01FDA Approved: FEMRING — Supplemental Application (Millicent US, Inc.)
The FDA approved a supplemental application for FEMRING (estradiol acetate) from Millicent US, Inc., indicating changes to the product's lab…
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CLINICAL_TRIALS trial_result · 2017-05-25Clinical Trial Update: Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women [Phase 3]
This Phase 3 clinical trial update reports results for estradiol vaginal softgel capsules in treating symptoms of vulvar and vaginal atrophy…
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FDA approval · 2017-03-17FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)
FDA approved a supplemental application for OSPHENA (ospemifene) filed by Duchesnay USA, Inc.
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FDA label_change · 2016-05-27FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)
FDA approved a supplemental labeling change for VAGIFEM (estradiol) submitted by Novo Nordisk.