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Last Updated: July 12, 2020

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CLINICAL TRIALS PROFILE FOR PROGESTERONE

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505(b)(2) Clinical Trials for Progesterone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT01300351 Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women Completed AstraZeneca Phase 3 2011-03-01 The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed a prior endocrine treatment.
OTC NCT01786252 Effect of hCG on Receptivity of the Human Endometrium Completed Michigan State University Phase 4 2013-01-01 Worldwide, 1 in 12 couples experience difficulty in getting pregnant and seek the help of assisted reproductive technologies (ART) such as in vitro fertilization (IVF-egg is fertilized by sperm outside the body), ovarian stimulation (medications are used to stimulate egg development) and intra-cytoplasmic injection (ICSI-single sperm is injected directly into the egg). Regardless of the ART procedure being performed, the newly fertilized embryo must still implant into the mothers endometrium (inner lining of uterus). This implantation process in humans is surprisingly inefficient and accounts for up to 50% of ART failures. Intrauterine infusion of hCG prior to embryo transfer has recently been shown to increase pregnancy rates but the cellular mechanism for this increase is unknown. Successful implantation requires the newly fertilized embryo and the endometrium develop in a synchronized manner. This coordinated development is accomplished, in part, by proteins secreted by the embryo which circulate throughout the maternal bloodstream and alert the maternal body organs (i.e. ovary, endometrium, breast, ect) that fertilization has occurred. One of the earliest of these secreted proteins is human chorionic gonadotropin (hCG), which is the molecule detected in over-the-counter pregnancy tests. From previous studies, we know that hCG production by the embryo alerts the ovary to continue producing progesterone, a hormone required for pregnancy. However, very little is known about the direct effect of hCG on the endometrium during early pregnancy in humans. Using animal models, hCG has been shown to induce specific changes in the endometrium, suggesting that embryo-derived hCG may be "priming" the endometrium in anticipation of implantation. The goal of this research study is to examine the direct effect of hCG on the human endometrium and see if this "priming effect" is also present in humans. Findings from this research may reveal whether pre-treatment with hCG can enhance ART outcomes, especially pregnancy rates.
New Combination NCT04296942 BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) Not yet recruiting National Cancer Institute (NCI) Phase 1 2020-03-10 Background: Breast cancer is the second most common cause of U.S. cancer deaths in women. Immunotherapy drugs use a person s immune system to fight cancer. Researchers want to see if a new combination of immunotherapy drugs can help treat breast cancer. Objective: To learn if a new combination of immunotherapy drugs can shrink tumors in people with metastatic breast cancer. Eligibility: Adults 18 and older who have been diagnosed with metastatic breast cancer, such as Triple Negative Breast Cancer (TNBC) or ER-/PR-/HER2+ Breast Cancer (HER2+BC) Design: Participants will be screened with: medical history physical exam disease confirmation (or tumor biopsy) tumor scans (computed tomography, magnetic resonance imaging, and/or bone scan) blood and urine tests electrocardiogram (measures the heart s electrical activity) echocardiogram (creates images of the heart). Participants will be assigned to 1 of 3 groups. The drugs they get will be based on the group they are in. Drugs are given in cycles. Each cycle = 3 weeks. They will repeat the screening tests during the study. Participants will get BN-Brachyury. It is 2 different vaccines. They are injected under the skin during different cycles. Participants will get M7824. They may get T-DM1. For both, a needle is inserted into a vein to give the drugs slowly. Participants may take Entinostat weekly by mouth. It is in tablet form. Participants will keep a pill diary. About 28 days after treatment ends, participants will have a follow-up visit or a telephone call. Then they will be contacted every 3 months for 1 year, then every 6 months for 1 year. They may have more tumor scans or continue treatment.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Progesterone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000175 The Effects of Sex Hormones on Cognition and Mood in Older Adults Terminated National Institute on Aging (NIA) N/A 1969-12-31 This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.
NCT00000176 Alzheimer's Disease Prevention Trial Completed National Institute on Aging (NIA) Phase 3 1969-12-31 This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's disease in women with a family history of Alzheimer's disease.
NCT00000295 Progesterone Treatment in Female Smokers - 12 Completed University of Minnesota - Clinical and Translational Science Institute Phase 2 1999-04-01 The purpose of this study is to investigate progesterone effects in female smokers
NCT00000295 Progesterone Treatment in Female Smokers - 12 Completed National Institute on Drug Abuse (NIDA) Phase 2 1999-04-01 The purpose of this study is to investigate progesterone effects in female smokers
NCT00000466 Postmenopausal Estrogen/Progestin Interventions (PEPI) Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 1987-09-01 To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 Postmenopausal Estrogen/Progestin Interventions (PEPI) Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 3 1987-09-01 To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Progesterone

Condition Name

Condition Name for Progesterone
Intervention Trials
Breast Cancer 140
Infertility 115
Polycystic Ovary Syndrome 34
Menopause 23
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Condition MeSH

Condition MeSH for Progesterone
Intervention Trials
Breast Neoplasms 240
Infertility 145
Premature Birth 61
Polycystic Ovary Syndrome 46
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Clinical Trial Locations for Progesterone

Trials by Country

Trials by Country for Progesterone
Location Trials
United Kingdom 71
Egypt 63
Spain 55
Italy 52
China 51
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Trials by US State

Trials by US State for Progesterone
Location Trials
California 107
New York 96
Texas 84
Illinois 76
Florida 71
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Clinical Trial Progress for Progesterone

Clinical Trial Phase

Clinical Trial Phase for Progesterone
Clinical Trial Phase Trials
Phase 4 174
Phase 3 186
Phase 2/Phase 3 33
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Clinical Trial Status

Clinical Trial Status for Progesterone
Clinical Trial Phase Trials
Completed 317
Recruiting 226
Not yet recruiting 137
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Clinical Trial Sponsors for Progesterone

Sponsor Name

Sponsor Name for Progesterone
Sponsor Trials
National Cancer Institute (NCI) 107
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 38
Cairo University 23
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Sponsor Type

Sponsor Type for Progesterone
Sponsor Trials
Other 1061
Industry 236
NIH 211
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