Vaginal Atrophy
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CLINICAL_TRIALS trial_result · 2017-10-18Clinical Trial Update: DHEA Against Vaginal Atrophy - Safety Study of 12 Months [Phase 3]
A Phase 3 safety trial evaluating dehydroepiandrosterone (DHEA) for vaginal atrophy has completed and posted results.
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CLINICAL_TRIALS trial_result · 2017-06-12Clinical Trial Update: Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy [Phase 3]
A Phase 3 clinical trial evaluating Dehydroepiandrosterone (DHEA) for vaginal atrophy has completed, with results posted in 2017.
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CLINICAL_TRIALS trial_result · 2017-06-01Clinical Trial Update: Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause [Phase 3]
A Phase 3 trial of intravaginal prasterone (DHEA) for vulvovaginal atrophy due to menopause has completed and posted results.
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CLINICAL_TRIALS trial_result · 2017-04-28Clinical Trial Update: Topical DHEA Against Vaginal Atrophy [Phase 3]
A Phase 3 trial evaluating topical DHEA (prasterone) for vaginal atrophy has completed and posted results.
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CLINICAL_TRIALS trial_result · 2017-04-25Clinical Trial Update: DHEA Against Vaginal Atrophy - 3-Month Efficacy Study [Phase 3]
Phase 3 clinical trial evaluating dehydroepiandrosterone (DHEA) for vaginal atrophy showed 3-month efficacy results; results were posted in …
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CLINICAL_TRIALS trial_result · 2017-04-07Clinical Trial Update: DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy [Phase 1]
Phase 1 study evaluating DHEA bioavailability after vaginal suppositories in postmenopausal women with vaginal atrophy. The study status is …
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FDA label_change · 2017-03-01FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)
The FDA approved a supplemental application for Vagifem (estradiol) by Novo Nordisk. This action updates the product labeling for the vagina…
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FDA approval · 2016-11-16FDA Approved: INTRAROSA — Original Application (Millicent US, Inc.)
FDA approved INTRAROSA (prasterone) from Millicent US, Inc. as an Original Application (NDA 208470) for the treatment of dyspareunia due to …
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CLINICAL_TRIALS trial_result · 2015-10-21Clinical Trial Update: An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy [Phase 2]
Phase 2 efficacy trial of Vagitocin for vaginal atrophy in postmenopausal women has completed.
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CLINICAL_TRIALS trial_result · 2015-10-08Clinical Trial Update: Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness. [Phase 4]
Phase 4 clinical trial evaluating the efficacy, safety and tolerability of a non-hormonal intravaginal gel for vaginal dryness in postmenopa…
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CLINICAL_TRIALS withdrawal · 2015-10-02Clinical Trial Update: Vaginal Creams to Reduce Vaginal Erosion in Pessary Users [Phase 2]
Phase 2 trial of vaginal creams to reduce vaginal erosion in pessary users has been withdrawn.
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CLINICAL_TRIALS trial_result · 2015-05-28Clinical Trial Update: A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin [Phase 2]
Phase 2 pharmacokinetic study comparing vaginal and intravenous administration of oxytocin in participants with vaginal atrophy; the study h…
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CLINICAL_TRIALS trial_result · 2015-05-27Clinical Trial Update: The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse [Phase 3]
Phase 3 trial evaluating local vaginal estrogen for postmenopausal pelvic organ prolapse (with vaginal atrophy) has completed.
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FDA approval · 2014-09-25FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for Premarin Vaginal (conjugated estrogens) from Wyeth Pharmaceuticals (Pfizer) to modify the pr…
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FDA label_change · 2014-08-12FDA Approved: ESTRING — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA supplemental approval for ESTRING (estradiol vaginal ring) to update the product labeling. The change concerns the approved use for vagi…
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CLINICAL_TRIALS trial_result · 2014-06-26Clinical Trial Update: Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo [Phase 3]
Phase 3 trial evaluating safety and bioequivalence of estradiol vaginal inserts (10 mcg) with Vagifem (10 mcg) and placebo for vaginal atrop…
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FDA approval · 2014-05-16FDA Approved: ESTRING — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA granted a supplemental approval for ESTRING (estradiol) from Pfizer, updating the product's labeling/indication.
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CLINICAL_TRIALS trial_result · 2013-07-15Clinical Trial Update: Vaginal Inflammation Markers in Postmenopausal Women With and Without Symptoms of Vaginal Inflammation
This completed clinical trial evaluated vaginal inflammation markers in postmenopausal women, comparing those with and without symptoms of v…
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CLINICAL_TRIALS trial_result · 2013-06-28Clinical Trial Update: Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity [Phase 3]
Phase 3 trial evaluating ospemifene for moderate to severe vaginal dryness and vaginal pain with sexual activity reported efficacy and safet…
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CLINICAL_TRIALS trial_result · 2013-06-28Clinical Trial Update: A Clinical Study to Evaluate the Safety of Ospemifene [Phase 3]
Phase 3 safety study of ospemifene completed with results posted in 2013.
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FDA approval · 2012-04-11FDA Approved: PREMARIN — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for Premarin (conjugated estrogens) filed by Wyeth Pharmaceuticals, a Pfizer subsidiary. The submiss…
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CLINICAL_TRIALS research · 2012-02-08Clinical Trial Update: VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women [Phase 1, Phase 2]
Clinical trial update for VG101 in Phase I/II for vulvar and vaginal atrophy in post-menopausal women; current status is unknown.
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CLINICAL_TRIALS trial_result · 2011-09-13Clinical Trial Update: Study of Oxytocin to Treat Vaginal Atrophy in Postmenopausal Women [Phase 2]
PepTonic Medical AB reports the completion of a Phase 2 trial evaluating oxytocin for vaginal atrophy in postmenopausal women.
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FDA approval · 2011-04-22FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for Premarin Vaginal (conjugated estrogens) from Wyeth Pharmaceuticals (Pfizer) to update the labeli…
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CLINICAL_TRIALS trial_result · 2011-04-07Clinical Trial Update: Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis [Phase 3]
Phase 3 clinical trial update examining endometrial safety of a low-dose Vagifem in postmenopausal women with atrophic vaginitis; results ha…