JamesAlanSimonMD

Obstetrics & Gynecology • Washington, DC

General Gynecology, Reproductive Endocrinology & Infertility

Clinical Professor of Obstetrics & Gynecology, Geo Wash University

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Office
1850 M St NW
Ste 450
Washington, DC 20036
Phone+1 202-293-1000

Fax+1 202-463-6150
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Education & Training

UCLA David Geffen School of Medicine/UCLA Medical CenterFellowship, Reproductive Endocrinology and Infertility, 1984
George Washington UniversityResidency, Obstetrics and Gynecology, 1978 - 1982
Rush Medical College of Rush University Medical CenterClass of 1978

Certifications & Licensure

CA State Medical License 1982 - Present
DC State Medical License 1979 - 2024
VA State Medical License 1979 - 2024
MD State Medical License 1979 - 2009
American Board of Obstetrics and Gynecology Obstetrics & Gynecology
American Board of Obstetrics and Gynecology Reproductive Endocrinology/Infertility
American Association of Sex Educators, Counselors and TherapistsCertified Sexuality Counselor
International Society for Clinical DensitometryCertified Clinical Densitometrist
International Society for the Study of Women's Sexual HealthISSWSH Fellow
North American Menopause SocietyNAMS Certified Menopause Practitioner

Awards, Honors, & Recognition

Top Washington Physician
Best Doctors In America
America’s Top Obstetricians and Gynecologists
Super Doctor SuperDoctors.com
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Clinical Trials

Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS) Start of enrollment: 2011 May 01
Completed
Phase 3
Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo Start of enrollment: 2012 Mar 01
Completed
Phase 3
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women Start of enrollment: 2015 Dec 22
Completed
Phase 3
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Start of enrollment: 2016 Sep 14
Completed
Phase 3
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Start of enrollment: 2017 Jun 30
Active, not recruiting
Phase 3
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain Start of enrollment: 2017 Jul 07
Completed
Phase 3
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women Start of enrollment: 2017 Jan 04
Active, not recruiting
Phase 3
Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis Start of enrollment: 2018 Jul 04
Terminated
Phase 2
Dysport in Vulvodynia Phase II Study Start of enrollment: 2018 Jun 11
Terminated
Phase 2
Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles Start of enrollment: 2021 Oct 26
Active, not recruiting
Phase 3
Roles: Contact
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Publications & Presentations

PubMed

5 citations
Review of menopausal hormone therapy with estradiol and progesterone versus other estrogens and progestins.
Shelli Graham, David F Archer, James A Simon, Kathleen M Ohleth, Brian Bernick> ;Gynecological Endocrinology. 2022 Nov 1
6 citations
Assessing the Burden of Illness Associated with Acquired Generalized Hypoactive Sexual Desire Disorder.
James A Simon, Amod Athavale, Rahul Ravindranath, Nandini Hadker, Amama Sadiq, Michelle Lim-Watson, Laura Williams, Julie Krop> ;Journal of Women's Health. 2022 May 1
6 citations
Clinically Meaningful Benefit in Women with Hypoactive Sexual Desire Disorder Treated with Flibanserin.
James A Simon, Anita H Clayton, Noel N Kim, Sejal Patel> ;Sexual Medicine. 2022 Feb 1
3 citations
Androgen therapy for women after menopause.
Kathryn I. Marko, James A. Simon> ;Best Practice & Research. Clinical Endocrinology & Metabolism. 2021 Oct 12
11 citations
Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life.
Nelson B. Watts, Neil Binkley, Charlotte D. Owens, Ayman Al-Hendy, Elizabeth E. Puscheck, Mohamad Shebley, William D. Schlaff, James A. Simon> ;Journal of Women's Health. 2021 Aug 25
4 citations
Evaluation of endometrial progesterone receptor expression after 12 weeks of exposure to a low-dose vaginal estradiol insert.
Sebastian Mirkin, James A. Simon, James H. Liu, David F. Archer, Patricia Castro, Shelli Graham, Brian Bernick, Barry S. Komm> ;Menopause. 2021 Jun 1
17 citations
A core outcome set for genitourinary symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative.
Sarah Lensen, Robin J Bell, Janet S Carpenter, Monica Christmas, Susan R Davis, Karen Giblin, Steven R Goldstein, Tim Hillard, Myra S Hunter, Stamatina Iliodromiti, Un...> ;Menopause. 2021 May 10
19 citations
A core outcome set for vasomotor symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative.
Sarah Lensen, David Archer, Robin J Bell, Janet S Carpenter, Monica Christmas, Susan R Davis, Karen Giblin, Steven R Goldstein, Tim Hillard, Myra S Hunter, Stamatina I...> ;Menopause. 2021 Apr 26
4 citations
Failure of a Meta-analysis: A Commentary on Glen Spielmans’s “Re-Analyzing Phase III Bremelanotide Trials for ‘Hypoactive Sexual Desire Disorder in Women’”
Sheryl A. Kingsberg, Anita H. Clayton, David Portman, Julie Krop, Robert Jordan, J. Lucas, James A. Simon> ;Journal of Sex Research. 2021 Apr 9
10 citations
International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in ...
Sharon J. Parish, James A. Simon, Susan R. Davis, Annamaria Giraldi, Irwin Goldstein, Sue W. Goldstein, Noel N. Kim, Sheryl A. Kingsberg, Abraham Morgentaler, Rossella...> ;Climacteric. 2021 Apr 1
13 citations
International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in ...
Sharon J. Parish, James A. Simon, Susan R. Davis, Annamaria Giraldi, Irwin Goldstein, Sue W. Goldstein, Noel N. Kim, Sheryl A. Kingsberg, Abraham Morgentaler, Rossella...> ;Journal of Women's Health. 2021 Apr 19
27 citations
International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in ...
Sharon J. Parish, James A. Simon, Susan R. Davis, Annamaria Giraldi, Irwin Goldstein, Sue W. Goldstein, Noel N. Kim, Sheryl A. Kingsberg, Abraham Morgentaler, Rossella...> ;The Journal of Sexual Medicine. 2021 Apr 1
2 citations
Segesterone acetate serum levels with a regression model of continuous use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system
James H. Liu, Marlena Gehret Plagianos, David F. Archer, James A. Simon, Shelli Graham, Brian Bernick, Sebastian Mirkin> ;Contraception. 2021 Mar 27
8 citations
Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results.
Anita L. Nelson, Robin Kroll, James A. Simon, Alfred N. Poindexter, Paula M. Castaño, Ronald T. Ackerman, Lisa Flood, Joseph Chiodo, Elizabeth I.O. Garner> ;Contraception. 2021 Mar 1
14 citations
Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids
Ayman Al-Hendy, Linda D. Bradley, Charlotte D. Owens, Hui Wang, Kurt T. Barnhart, Eve C. Feinberg, William D. Schlaff, Elizabeth E. Puscheck, Alice Wang, Veronica Gill...> ;American Journal of Obstetrics and Gynecology. 2021 Jan 1
TX-001HR is associated with a clinically meaningful effect on severity of moderate to severe vasomotor symptoms in the REPLENISH trial.
Ginger D Constantine, James A Simon, James H Pickar, Dennis A Revicki, Shelli Graham, Brian Bernick, Sebastian Mirkin, Kaunitz, A.> ;Menopause. 2020 Nov 1
3 citations
The Masquerading, Masculinizing Tumor: A Case Report and Review of the Literature.
Alexis LeVee, Nissi Suppogu, Christine Walsh, Wendy Sacks, James A. Simon, Chrisandra Shufelt> ;Journal of Women's Health. 2021 Jul 12
10 citations
Female Hypoactive Sexual Desire Disorder: A Practical Guide to Causes, Clinical Diagnosis, and Treatment
Sheryl A. Kingsberg, James A. Simon> ;Journal of Women's Health. 2020 Aug 17
24 citations
No increase in incidence or risk of recurrence of breast cancer in ospemifene-treated patients with vulvovaginal atrophy (VVA)
Bin Cai, James A. Simon, Paola Villa, Nicoletta Biglia, Nicholas Panay, Stora Djumaeva, Martire Particco, Hemanth Kanakamedala, Corrado Altomare> ;Maturitas. 2020 Jul 10
27 citations
Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas.
James A. Simon, Ayman Al-Hendy, David F. Archer, Kurt T. Barnhart, Linda D. Bradley, Bruce R. Carr, Thomas Dayspring, Eve C. Feinberg, Veronica Gillispie, Sandra Hurta...> ;Obstetrics and Gynecology. 2020 Jun 1
13 citations
Workshop on normal reference ranges for estradiol in postmenopausal women, September 2019, Chicago, Illinois
Richard J. Santen, JoAnn V. Pinkerton, James H. Liu, Alvin M. Matsumoto, Roger A. Lobo, Susan R. Davis, James A. Simon> ;Menopause. 2020 May 4
3 citations
Methodological Challenges in Studying Testosterone Therapies for Hypoactive Sexual Desire Disorder in Women.
Tami S. Rowen, Susan R. Davis, Sharon J. Parish, James A. Simon, Linda Vignozzi> ;The Journal of Sexual Medicine. 2020 Apr 1
6 citations
The Saga of Testosterone for Menopausal Women at the Food and Drug Administration (FDA).
James A. Simon, Meredith D. Kapner> ;The Journal of Sexual Medicine. 2020 Apr 1
4 citations
MsFLASH network vaginal health trial: absence of evidence is NOT evidence of absence.
Vanessa A. Lukas, James A. Simon> ;Menopause. 2020 Jun 1
5 citations
Physical characteristics and properties of estradiol softgel vaginal inserts.
James A. Simon, James H. Pickar, Annette M. Shadiack, Bharat Warrier, Shelli Graham, Brian Bernick, Sebastian Mirkin> ;Menopause. 2020 Feb 1
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Press Mentions

Are Hormones for Menopause Safe?May 11th, 2019
Dr. James Simon, Award-Winning Physician, Presents on Ovaprene® as a Promising Novel Non-Hormonal Contraceptive Method in Clinical DevelopmentApril 15th, 2019
‘Female Viagra’ Still Risky to Mix with Alcohol – What to KnowApril 15th, 2019
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