The Experts below are selected from a list of 2424 Experts worldwide ranked by ideXlab platform
Mona M. Shangold - One of the best experts on this subject based on the ideXlab platform.
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A new clinical option for hormone replacement therapy in women with secondary amenorrhea: effects of cyclic administration of progesterone from the sustained-release vaginal gel Crinone (4% and 8%) on endometrial morphologic features and Withdrawal b
American Journal of Obstetrics and Gynecology, 1999Co-Authors: M P Warren, B M Biller, Mona M. ShangoldAbstract:Abstract Objective: The objective of this study was to evaluate the safety and efficacy of 2 doses of a transvaginal polycarbophil-based progesterone gel (4% and 8%) in hormone replacement therapy. Study Design: This multicenter, randomized, parallel-group, open-label 3-month study included 127 women with secondary amenorrhea. Estrogenized patients applied transvaginal progesterone (4% or 8%) every other day for 6 doses per month. Efficacy was based on endometrial biopsy findings and Withdrawal Bleeding. McNemar's test was used to compare incidence of adverse events before and during treatment. Results: Progestational changes were found in 92% (Crinone 4%) and 100% (Crinone 8%) of patients with evaluable biopsies. Withdrawal Bleeding was experienced by 81% (Crinone 4%) and 82% (Crinone 8%) of the patients. No patient experienced any serious side effect related to treatment. The incidence of most side effects, including psychologic symptoms, decreased with progesterone treatment compared with estrogen alone therapy. Compliance exceeded 98% for both doses. Conclusions: Crinone is a novel, effective, and well-tolerated option for hormone replacement therapy in women with secondary amenorrhea. (Am J Obstet Gynecol 1999;180:42-8.)
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Factors associated with Withdrawal Bleeding after administration of oral micronized progesterone in women with secondary amenorrhea
Fertility and sterility, 1991Co-Authors: Mona M. Shangold, Thomas P. Tomai, Janine D. Cook, Samuel L. Jacobs, Michael J. Zinaman, Su Y. Chin, James A. SimonAbstract:Objective To compare two dosages of oral micronized progesterone (P) and placebo for Withdrawal Bleeding and side effects. Design Prospective, randomized, double-blind. Setting Academic institution. Participants: Out of 190 screened with oligomenorrhea/amenorrhea, 60 who qualified completed the study. Interventions A 10-day course of (1) oral micronized P 300mg, (2) oral micronized P 200mg, or (3) placebo. Main Outcome Measures Withdrawal Bleeding, side effects, and changes in lipids. Endogenous estradiol (E 2 ) concentrations at baseline and P concentrations during treatment were correlated with Bleeding response. Results Withdrawal Bleeding occurred in 90% of women taking 300mg, 58% of women taking 200mg, and 29% of women taking placebo ( P P =not significant). Lipid concentrations were unchanged. Endogenous E 2 and treatment P concentrations were of limited predictive value for Withdrawal Bleeding. Conclusions Progesterone 300mg induced significantly more Withdrawal Bleeding than placebo, with similar side effects. Bleeding response cannot be predicted reliably from E 2 and P concentrations.
M P Warren - One of the best experts on this subject based on the ideXlab platform.
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A new clinical option for hormone replacement therapy in women with secondary amenorrhea: effects of cyclic administration of progesterone from the sustained-release vaginal gel Crinone (4% and 8%) on endometrial morphologic features and Withdrawal b
American journal of obstetrics and gynecology, 1999Co-Authors: M P Warren, B M Biller, M M ShangoldAbstract:The objective of this study was to evaluate the safety and efficacy of 2 doses of a transvaginal polycarbophil-based progesterone gel (4% and 8%) in hormone replacement therapy. This multicenter, randomized, parallel-group, open-label 3-month study included 127 women with secondary amenorrhea. Estrogenized patients applied transvaginal progesterone (4% or 8%) every other day for 6 doses per month. Efficacy was based on endometrial biopsy findings and Withdrawal Bleeding. McNemar's test was used to compare incidence of adverse events before and during treatment. Progestational changes were found in 92% (Crinone 4%) and 100% (Crinone 8%) of patients with evaluable biopsies. Withdrawal Bleeding was experienced by 81% (Crinone 4%) and 82% (Crinone 8%) of the patients. No patient experienced any serious side effect related to treatment. The incidence of most side effects, including psychologic symptoms, decreased with progesterone treatment compared with estrogen alone therapy. Compliance exceeded 98% for both doses. Crinone is a novel, effective, and well-tolerated option for hormone replacement therapy in women with secondary amenorrhea.
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A new clinical option for hormone replacement therapy in women with secondary amenorrhea: effects of cyclic administration of progesterone from the sustained-release vaginal gel Crinone (4% and 8%) on endometrial morphologic features and Withdrawal b
American Journal of Obstetrics and Gynecology, 1999Co-Authors: M P Warren, B M Biller, Mona M. ShangoldAbstract:Abstract Objective: The objective of this study was to evaluate the safety and efficacy of 2 doses of a transvaginal polycarbophil-based progesterone gel (4% and 8%) in hormone replacement therapy. Study Design: This multicenter, randomized, parallel-group, open-label 3-month study included 127 women with secondary amenorrhea. Estrogenized patients applied transvaginal progesterone (4% or 8%) every other day for 6 doses per month. Efficacy was based on endometrial biopsy findings and Withdrawal Bleeding. McNemar's test was used to compare incidence of adverse events before and during treatment. Results: Progestational changes were found in 92% (Crinone 4%) and 100% (Crinone 8%) of patients with evaluable biopsies. Withdrawal Bleeding was experienced by 81% (Crinone 4%) and 82% (Crinone 8%) of the patients. No patient experienced any serious side effect related to treatment. The incidence of most side effects, including psychologic symptoms, decreased with progesterone treatment compared with estrogen alone therapy. Compliance exceeded 98% for both doses. Conclusions: Crinone is a novel, effective, and well-tolerated option for hormone replacement therapy in women with secondary amenorrhea. (Am J Obstet Gynecol 1999;180:42-8.)
Anja Schmidt - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and Safety of a Combined Oral Contraceptive Containing Estradiol Valerate/Dienogest: Results from a Clinical Study Conducted in North America
Journal of Womens Health, 2013Co-Authors: Anita L. Nelson, Susanne Parke, Uwe Mellinger, Edio Zampaglione, Anja SchmidtAbstract:Abstract Background: This study investigated the efficacy and safety of a combined oral contraceptive (COC) containing estradiol valerate/dienogest (E2V/DNG). Methods: This was a multicenter, noncomparative, 13-cycle (extended to 28 cycles) study conducted in the United States and Canada. Contraceptive efficacy was calculated as a Pearl Index for 13 cycles, based on all on-treatment pregnancies; Bleeding patterns were calculated based on Bleeding and spotting information recorded daily in diary cards. Safety events during a 16-month extension study were added to the 1-year data. Results: In total, 499 women, aged 18–35 years, were enrolled, and 490 of them were included in the full analysis set for contraceptive efficacy. Five pregnancies occurred in the first year (unadjusted Pearl Index=1.64). In cycles 1–12, an average 23.5% of women had absent scheduled (Withdrawal) Bleeding. Among women with scheduled (Withdrawal) Bleeding, Bleeding started after a median of 2 days after intake of the last DNG-contai...
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Efficacy and Safety of a Combined Oral Contraceptive Containing Estradiol Valerate/Dienogest: Results from a Clinical Study Conducted in North America
Journal of Womens Health, 2013Co-Authors: Anita L. Nelson, Susanne Parke, Uwe Mellinger, Edio Zampaglione, Anja SchmidtAbstract:Abstract Background: This study investigated the efficacy and safety of a combined oral contraceptive (COC) containing estradiol valerate/dienogest (E2V/DNG). Methods: This was a multicenter, noncomparative, 13-cycle (extended to 28 cycles) study conducted in the United States and Canada. Contraceptive efficacy was calculated as a Pearl Index for 13 cycles, based on all on-treatment pregnancies; Bleeding patterns were calculated based on Bleeding and spotting information recorded daily in diary cards. Safety events during a 16-month extension study were added to the 1-year data. Results: In total, 499 women, aged 18–35 years, were enrolled, and 490 of them were included in the full analysis set for contraceptive efficacy. Five pregnancies occurred in the first year (unadjusted Pearl Index=1.64). In cycles 1–12, an average 23.5% of women had absent scheduled (Withdrawal) Bleeding. Among women with scheduled (Withdrawal) Bleeding, Bleeding started after a median of 2 days after intake of the last DNG-contai...
M M Shangold - One of the best experts on this subject based on the ideXlab platform.
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A new clinical option for hormone replacement therapy in women with secondary amenorrhea: effects of cyclic administration of progesterone from the sustained-release vaginal gel Crinone (4% and 8%) on endometrial morphologic features and Withdrawal b
American journal of obstetrics and gynecology, 1999Co-Authors: M P Warren, B M Biller, M M ShangoldAbstract:The objective of this study was to evaluate the safety and efficacy of 2 doses of a transvaginal polycarbophil-based progesterone gel (4% and 8%) in hormone replacement therapy. This multicenter, randomized, parallel-group, open-label 3-month study included 127 women with secondary amenorrhea. Estrogenized patients applied transvaginal progesterone (4% or 8%) every other day for 6 doses per month. Efficacy was based on endometrial biopsy findings and Withdrawal Bleeding. McNemar's test was used to compare incidence of adverse events before and during treatment. Progestational changes were found in 92% (Crinone 4%) and 100% (Crinone 8%) of patients with evaluable biopsies. Withdrawal Bleeding was experienced by 81% (Crinone 4%) and 82% (Crinone 8%) of the patients. No patient experienced any serious side effect related to treatment. The incidence of most side effects, including psychologic symptoms, decreased with progesterone treatment compared with estrogen alone therapy. Compliance exceeded 98% for both doses. Crinone is a novel, effective, and well-tolerated option for hormone replacement therapy in women with secondary amenorrhea.
B M Biller - One of the best experts on this subject based on the ideXlab platform.
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A new clinical option for hormone replacement therapy in women with secondary amenorrhea: effects of cyclic administration of progesterone from the sustained-release vaginal gel Crinone (4% and 8%) on endometrial morphologic features and Withdrawal b
American journal of obstetrics and gynecology, 1999Co-Authors: M P Warren, B M Biller, M M ShangoldAbstract:The objective of this study was to evaluate the safety and efficacy of 2 doses of a transvaginal polycarbophil-based progesterone gel (4% and 8%) in hormone replacement therapy. This multicenter, randomized, parallel-group, open-label 3-month study included 127 women with secondary amenorrhea. Estrogenized patients applied transvaginal progesterone (4% or 8%) every other day for 6 doses per month. Efficacy was based on endometrial biopsy findings and Withdrawal Bleeding. McNemar's test was used to compare incidence of adverse events before and during treatment. Progestational changes were found in 92% (Crinone 4%) and 100% (Crinone 8%) of patients with evaluable biopsies. Withdrawal Bleeding was experienced by 81% (Crinone 4%) and 82% (Crinone 8%) of the patients. No patient experienced any serious side effect related to treatment. The incidence of most side effects, including psychologic symptoms, decreased with progesterone treatment compared with estrogen alone therapy. Compliance exceeded 98% for both doses. Crinone is a novel, effective, and well-tolerated option for hormone replacement therapy in women with secondary amenorrhea.
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A new clinical option for hormone replacement therapy in women with secondary amenorrhea: effects of cyclic administration of progesterone from the sustained-release vaginal gel Crinone (4% and 8%) on endometrial morphologic features and Withdrawal b
American Journal of Obstetrics and Gynecology, 1999Co-Authors: M P Warren, B M Biller, Mona M. ShangoldAbstract:Abstract Objective: The objective of this study was to evaluate the safety and efficacy of 2 doses of a transvaginal polycarbophil-based progesterone gel (4% and 8%) in hormone replacement therapy. Study Design: This multicenter, randomized, parallel-group, open-label 3-month study included 127 women with secondary amenorrhea. Estrogenized patients applied transvaginal progesterone (4% or 8%) every other day for 6 doses per month. Efficacy was based on endometrial biopsy findings and Withdrawal Bleeding. McNemar's test was used to compare incidence of adverse events before and during treatment. Results: Progestational changes were found in 92% (Crinone 4%) and 100% (Crinone 8%) of patients with evaluable biopsies. Withdrawal Bleeding was experienced by 81% (Crinone 4%) and 82% (Crinone 8%) of the patients. No patient experienced any serious side effect related to treatment. The incidence of most side effects, including psychologic symptoms, decreased with progesterone treatment compared with estrogen alone therapy. Compliance exceeded 98% for both doses. Conclusions: Crinone is a novel, effective, and well-tolerated option for hormone replacement therapy in women with secondary amenorrhea. (Am J Obstet Gynecol 1999;180:42-8.)
