Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
Summary
This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.
Timeline
- Start
- 2014-09
- Primary completion
- 2015-10
- Completion
- 2015-10
Outcome
Met primary endpoint
paper The E2 vaginal insert (4 µg and 10 µg) significantly improved the percentages of superficial and parabasal cells (p < .0001), vaginal pH (p < .0001), and the severity score for dyspareunia (p < .05) PMID 30238814 ↗
registry analysis (superiority or other test); Estradiol 4mcg Vaginal Softgel Capsule vs Placebo; p < 0.0001; Mixed Models Analysis NCT02253173 ↗
registry analysis (superiority or other test); Estradiol 10mcg Vaginal Softgel Capsule vs Placebo; p < 0.0001; Mixed Models Analysis NCT02253173 ↗
registry analysis (superiority or other test); Estradiol 25mcg Vaginal Softgel Capsule vs Placebo; p < 0.0001; Mixed Models Analysis NCT02253173 ↗
registry analysis (superiority or other test); Estradiol 4mcg Vaginal Softgel Capsule vs Placebo; p = 0.0149; Mixed Models Analysis NCT02253173 ↗
release “The results showed patients treated with TX-004HR achieved a statistically significant improvement over placebo across all four co-primary endpoints at all three doses” therapeuticsmd.com ↗
Publications
- Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.
- Mirkin S, Simon JA, Liu JH, Archer DF, Castro PD, Graham S, Bernick B, Komm B. Evaluation of endometrial progesterone receptor expression after 12 weeks of exposure to a low-dose vaginal estradiol insert. Menopause. 2021 May 28;28(9):998-1003. doi: 10.1097/GME.0000000000001801.
- Constantine G, Millheiser LS, Kaunitz AM, Parish SJ, Graham S, Bernick B, Mirkin S. Early onset of action with a 17beta-estradiol, softgel, vaginal insert for treating vulvar and vaginal atrophy and moderate to severe dyspareunia. Menopause. 2019 Nov;26(11):1259-1264. doi: 10.1097/GME.0000000000001394.
- Constantine GD, Simon JA, Pickar JH, Archer DF, Bernick B, Graham S, Mirkin S. Estradiol vaginal inserts (4 microg and 10 microg) for treating moderate to severe vulvar and vaginal atrophy: a review of phase 3 safety, efficacy and pharmacokinetic data. Curr Med Res Opin. 2018 Dec;34(12):2131-2136. doi: 10.1080/03007995.2018.1527578. Epub 2018 Sep 28.
- Constantine GD, Bouchard C, Pickar JH, Archer DF, Graham S, Bernick B, Mirkin S. Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women. J Womens Health (Larchmt). 2017 Jun;26(6):616-623. doi: 10.1089/jwh.2016.6187. Epub 2017 Mar 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 4 ug | Other |
| Subject | Estradiol | Other / unclassified | 10 ug | Other |
| Subject | Estradiol | Other / unclassified | 25 ug | Other |