Pharmacokinetics and Tolerability of a Novel 17β-Estradiol and Progesterone Intravaginal Ring in Sheep

Authors: Weiss, Herman, Martell, Bridget, Constantine, Ginger D., Davis, Sarah M., Vidal, Justin D., Mayer, Philip R., Doorbar, Martin, Friend, David R.

Source: In Journal of Pharmaceutical Sciences August 2019 108(8):2677-2684

TX-001HR is associated with a clinically meaningful effect on severity of moderate to severe vasomotor symptoms in the REPLENISH trial

Authors: Constantine, Ginger D., Simon, James A., Kaunitz, Andrew M., Pickar, James H., Revicki, Dennis A., Graham, Shelli, Bernick, Brian, Mirkin, Sebastian

Source: Menopause. 27(11):1236-1241

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100112493481.0x000001&indx=1&recIds=ETOCvdc_100112493481.0x000001

17β-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial

Authors: Kaunitz, Andrew M., Bitner, Diana, Constantine, Ginger D., Bernick, Brian, Graham, Shelli, Mirkin, Sebastian

Source: Menopause. 27(12):1382-1387

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100112484482.0x000001&indx=1&recIds=ETOCvdc_100112484482.0x000001

Systemic estradiol levels with low-dose vaginal estrogens

Authors: Santen, Richard J., Mirkin, Sebastian, Bernick, Brian, Constantine, Ginger D.

Source: Menopause. 27(3):361-370

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100175847964.0x000001&indx=1&recIds=ETOCvdc_100175847964.0x000001

Pharmacokinetics and tolerability of a novel progesterone intravaginal ring in sheep

Authors: Weiss, Herman, Martell, Bridget, Constantine, Ginger D., Davis, Sarah M., Vidal, Justin D., Mayer, Philip R., Doorbar, Martin, Friend, David R.

Source: Drug delivery and translational research. 9(5):1008-1016

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100130445671.0x000001&indx=1&recIds=ETOCvdc_100130445671.0x000001

Increased Incidence of Endometrial Cancer Following the Women's Health Initiative: An Assessment of Risk Factors

Authors: Constantine, Ginger D., Kessler, Grant, Graham, Shelli, Goldstein, Steven R.

Source: Journal of women's health -New York. 28(2):237-243

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100084562224.0x000001&indx=1&recIds=ETOCvdc_100084562224.0x000001

Estradiol and progesterone bioavailability for moderate to severe vasomotor symptom treatment and endometrial protection with the continuous-combined regimen of TX-001HR (oral estradiol and progesterone capsules)

Authors: Lobo, Rogerio A., Liu, James, Stanczyk, Frank Z., Constantine, Ginger D., Pickar, James H., Shadiack, Annette M., Bernick, Brian, Mirkin, Sebastian

Source: Menopause. 26(7):720-727

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100175838488.0x000001&indx=1&recIds=ETOCvdc_100175838488.0x000001

Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review

Authors: Constantine, Ginger D., Graham, Shelli, Lapane, Kate, Ohleth, Kathleen, Bernick, Brian, Liu, James, Mirkin, Sebastian

Source: Menopause. 26(7):800-807

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100175839178.0x000001&indx=1&recIds=ETOCvdc_100175839178.0x000001

Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17β-estradiol/progesterone

Authors: Mirkin, Sebastian, Graham, Shelli, Revicki, Dennis A., Bender, Randall H., Bernick, Brian, Constantine, Ginger D.

Source: Menopause. 26(6):637-642

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100175837449.0x000001&indx=1&recIds=ETOCvdc_100175837449.0x000001

Evaluation of clinical meaningfulness of estrogen plus progesterone oral capsule (TX-001HR) on moderate to severe vasomotor symptoms

Authors: Constantine, Ginger D., Revicki, Dennis A., Kagan, Risa, Simon, James A., Graham, Shelli, Bernick, Brian, Mirkin, Sebastian

Source: Menopause. 26(5):513-519

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100175835245.0x000001&indx=1&recIds=ETOCvdc_100175835245.0x000001

Estradiol vaginal inserts (4 µg and 10 µg) for treating moderate to severe vulvar and vaginal atrophy: a review of phase 3 safety, efficacy and pharmacokinetic data

Authors: Constantine, Ginger D., Simon, James A., Pickar, James H., Archer, David F., Bernick, Brian, Graham, Shelli, Mirkin, Sebastian

Source: Current medical research and opinion. 34(12):2131-2136

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100131309128.0x000001&indx=1&recIds=ETOCvdc_100131309128.0x000001

TX-004HR Improves Sexual Function as Measured by the Female Sexual Function Index in Postmenopausal Women With Vulvar and Vaginal Atrophy: The REJOICE Trial

Authors: Kingsberg, Sheryl A., Derogatis, Leonard, Simon, James A., Constantine, Ginger D., Graham, Shelli, Bernick, Brian, Gasper, Gina, Mirkin, Sebastian

Source: In The Journal of Sexual Medicine December 2016 13(12):1930-1937

Clinical investigation of RAD1901, a novel estrogen receptor ligand, for the treatment of postmenopausal vasomotor symptoms: a phase 2 randomized, placebo-controlled, double-blind, dose-ranging, proof-of-concept trial

Authors: Hattersley, Gary, Harris, Alan G., Simon, James A., Constantine, Ginger D.

Source: Menopause. 24(1):92-99

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100042285414.0x000001&indx=1&recIds=ETOCvdc_100042285414.0x000001

Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR

Authors: Kingsberg, Sheryl A., Kroll, Robin, Goldstein, Irwin, Kushner, Harvey, Bernick, Brian, Graham, Shelli, Mirkin, Sebastian, Constantine, Ginger D.

Source: Menopause. 24(8):894-899

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100047092032.0x000001&indx=1&recIds=ETOCvdc_100047092032.0x000001

Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial

Authors: Simon, James A., Archer, David F., Kagan, Risa, Bernick, Brian, Graham, Shelli, Constantine, Ginger D., Mirkin, Sebastian

Source: Menopause. 24(9):1003-1010

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100048311480.0x000001&indx=1&recIds=ETOCvdc_100048311480.0x000001

TX-004HR vaginal estradiol has negligible to very low systemic absorption of estradiol

Authors: Archer, David F., Constantine, Ginger D., Simon, James A., Kushner, Harvey, Mayer, Philip, Bernick, Brian, Graham, Shelli, Mirkin, Sebastian

Source: Menopause. 24(5):510-516

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100044240441.0x000001&indx=1&recIds=ETOCvdc_100044240441.0x000001

Compounded non-FDA–approved menopausal hormone therapy prescriptions have increased: results of a pharmacy survey

Authors: Pinkerton, JoAnn V., Constantine, Ginger D.

Source: Menopause. 23(4):359-367

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100037157403.0x000001&indx=1&recIds=ETOCvdc_100037157403.0x000001

Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries

Authors: Constantine, Ginger D., Graham, Shelli, Clerinx, Cathy, Bernick, Brian A., Krassan, Mitchell, Mirkin, Sebastian, Currie, Heather

Source: Post reproductive health. 22(3):112-122

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN607991605&indx=1&recIds=ETOCRN607991605

Prescribing of FDA-approved and compounded hormone therapy differs by specialty

Authors: Constantine, Ginger D., Archer, David F., Graham, Shelli, Bernick, Brian A., Mirkin, Sebastian

Source: Menopause. 23(10):1075-1082

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100036033884.0x000001&indx=1&recIds=ETOCvdc_100036033884.0x000001

Ospemifene's effect on vasomotor symptoms: a post hoc analysis of phase 2 and 3 clinical data

Authors: Constantine, Ginger D., Archer, David F., Pollycove, Ricki, Jiang, Wei, Altomare, Corrado, Pinkerton, JoAnn V.

Source: Menopause. 23(9):957-964

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100035899567.0x000001&indx=1&recIds=ETOCvdc_100035899567.0x000001