Search Results - "CONSTANTINE, Ginger"

Increased Incidence of Endometrial Cancer Following the Women's Health Initiative: An Assessment of Risk Factors by Constantine, Ginger D, Kessler, Grant, Graham, Shelli, Goldstein, Steven R

“…The Surveillance, Epidemiology, and End Result (SEER) database shows a variable increase in endometrial cancer incidence over time. The objective of this…”
Get more information

Systemic estradiol levels with low-dose vaginal estrogens by Santen, Richard J., Mirkin, Sebastian, Bernick, Brian, Constantine, Ginger D.

“…OBJECTIVES:To critically evaluate published systemic estradiol levels during use of low-dose vaginal estrogens considering detection method and estrogen dose;…”
Get full text

Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women by Lindsay, Robert, Ph.D, Gallagher, J. Christopher, M.D, Kagan, Risa, M.D, Pickar, James H., M.D, Constantine, Ginger, M.D

“…Objective To evaluate the efficacy of the tissue-selective estrogen complex, bazedoxifene/conjugated estrogens (BZA/CE), for postmenopausal osteoporosis…”
Get full text

Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review by Constantine, Ginger D, Graham, Shelli, Lapane, Kate, Ohleth, Kathleen, Bernick, Brian, Liu, James, Mirkin, Sebastian

“…OBJECTIVE:The aim of the study was to systematically review studies that evaluated endometrial hyperplasia or cancer incidence with unopposed vaginal…”
Get full text

Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile by Lobo, Rogerio A., M.D, Pinkerton, JoAnn V., M.D, Gass, Margery L.S., M.D, Dorin, Maxine H., M.D, Ronkin, Sheila, M.D, Pickar, James H., M.D, Constantine, Ginger, M.D

“…Objective To evaluate the effects of a tissue-selective estrogen complex (TSEC) composed of bazedoxifene/conjugated estrogens (BZA/CE) on menopausal symptoms,…”
Get full text

The REJOICE trial: a phase 3 randomized, controlled trial evaluating the safety and efficacy of a novel vaginal estradiol soft-gel capsule for symptomatic vulvar and vaginal atrophy by Constantine, Ginger D, Simon, James A, Pickar, James H, Archer, David F, Kushner, Harvey, Bernick, Brian, Gasper, Gina, Graham, Shelli, Mirkin, Sebastian

“…OBJECTIVE:To evaluate the safety and efficacy of TX-004HR vaginal estradiol soft-gel capsules for moderate-to-severe dyspareunia associated with postmenopausal…”
Get full text

Compounded non-FDA–approved menopausal hormone therapy prescriptions have increased: results of a pharmacy survey by Pinkerton, JoAnn V, Constantine, Ginger D

“…OBJECTIVE:From a survey of compounding pharmacists, specific questions regarding compounded menopausal hormone therapy were used to estimate compounded hormone…”
Get full text

17β-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial by Kaunitz, Andrew M., Bitner, Diana, Constantine, Ginger D., Bernick, Brian, Graham, Shelli, Mirkin, Sebastian

“…OBJECTIVE:To examine responder rates and vasomotor symptom-free days with oral 17β-estradiol/progesterone (E2/P4; TX-001HR) versus placebo in the REPLENISH…”
Get full text

Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17β-estradiol/progesterone by Mirkin, Sebastian, Graham, Shelli, Revicki, Dennis A, Bender, Randall H, Bernick, Brian, Constantine, Ginger D

“…OBJECTIVE:To characterize the impact of TX-001HR on the relationship between vasomotor symptom (VMS) improvement and quality of life and sleep…”
Get full text

Evaluation of clinical meaningfulness of estrogen plus progesterone oral capsule (TX-001HR) on moderate to severe vasomotor symptoms by Constantine, Ginger D, Revicki, Dennis A, Kagan, Risa, Simon, James A, Graham, Shelli, Bernick, Brian, Mirkin, Sebastian

“…OBJECTIVE:The aim of this study was to determine the clinical meaningfulness of TX-001HR in reducing moderate to severe vasomotor symptoms (VMS) in menopausal…”
Get full text

Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial by Simon, James A, Archer, David F, Kagan, Risa, Bernick, Brian, Graham, Shelli, Constantine, Ginger D, Mirkin, Sebastian

“…OBJECTIVE:To evaluate the response of the vaginal mucosa with TX-004HR and its correlation with vulvar and vaginal atrophy (VVA) symptoms, and whether visual…”
Get full text

Efficacy of Bazedoxifene in Reducing New Vertebral Fracture Risk in Postmenopausal Women With Osteoporosis: Results From a 3‐Year, Randomized, Placebo‐, and Active‐Controlled Clinical Trial by Silverman, Stuart L, Christiansen, Claus, Genant, Harry K, Vukicevic, Slobodan, Zanchetta, José R, de Villiers, Tobie J, Constantine, Ginger D, Chines, Arkadi A

“…In this 3‐yr, randomized, double‐blind, placebo‐ and active‐controlled study, healthy postmenopausal women with osteoporosis (55–85 yr of age) were treated…”
Get full text

TX-004HR vaginal estradiol has negligible to very low systemic absorption of estradiol by Archer, David F, Constantine, Ginger D, Simon, James A, Kushner, Harvey, Mayer, Philip, Bernick, Brian, Graham, Shelli, Mirkin, Sebastian

“…OBJECTIVE:To evaluate the pharmacokinetics of TX-004HR vaginal estradiol softgel capsules when used for treating moderate-to-severe dyspareunia in…”
Get full text

Effects of ospemifene on bone parameters including clinical biomarkers in postmenopausal women by Constantine, Ginger D, Kagan, Risa, Miller, Paul D

“…OBJECTIVE:Ospemifene is an estrogen-receptor agonist/antagonist (also known as a selective estrogen-receptor modulator) that is FDA approved for the treatment…”
Get full text

Endometrial safety of ospemifene: results of the phase 2/3 clinical development program by Constantine, Ginger D, Goldstein, Steven R, Archer, David F

“…OBJECTIVEThis study aims to assess the endometrial safety of ospemifene based on phase 2/3 clinical trials of postmenopausal women with up to 52 weeks of…”
Get full text

Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial by Pinkerton, JoAnn V., Utian, Wulf H., Constantine, Ginger D., Olivier, Sophie, Pickar, James H.

“…OBJECTIVE:The aim of this study was to assess the safety and efficacy of bazedoxifene (BZA)/conjugated estrogens (CE) treating moderate to severe vasomotor…”
Get full text

TX-001HR is associated with a clinically meaningful effect on severity of moderate to severe vasomotor symptoms in the REPLENISH trial by Constantine, Ginger D., Simon, James A., Kaunitz, Andrew M., Pickar, James H., Revicki, Dennis A., Graham, Shelli, Bernick, Brian, Mirkin, Sebastian

“…OBJECTIVE:The aim of the study was to evaluate the clinically meaningful effect of oral TX-001HR (17β-estradiol [E2]/progesterone [P4]) capsules on hot flushes…”
Get full text

Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis by Christiansen, Claus, Chesnut, 3rd, Charles H, Adachi, Jonathan D, Brown, Jacques P, Fernandes, César E, Kung, Annie Wc, Palacios, Santiago, Levine, Amy B, Chines, Arkadi A, Constantine, Ginger D

“…We report the safety findings from a 3-year phase 3 study (NCT00205777) of bazedoxifene, a novel selective estrogen receptor modulator under development for…”
Get full text

Effects of Bazedoxifene on BMD and Bone Turnover in Postmenopausal Women: 2‐Yr Results of a Randomized, Double‐Blind, Placebo‐, and Active‐Controlled Study by Miller, Paul D, Chines, Arkadi A, Christiansen, Claus, Hoeck, Hans C, Kendler, David L, Lewiecki, E Michael, Woodson, Grattan, Levine, Amy B, Constantine, Ginger, Delmas, Pierre D

“…Osteoporosis is an increasingly common health concern in postmenopausal women. In a 2‐yr phase III study, bazedoxifene prevented bone loss, reduced bone…”
Get full text

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 by Constantine, Ginger D, Bouchard, Celine, Pickar, James H, Archer, David F, Graham, Shelli, Bernick, Brian, Mirkin, Sebastian

“…The 12-week, randomized, double-blind, placebo-controlled, multicenter, phase 3 REJOICE trial demonstrated that TX-004HR, an investigational, applicator-free,…”
Get more information