progesterone
Trade name: progestasert
Approved
Nov 1, 1974
Progesterone is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids of uterine cancer. Progesterone, converted from pregnenolone, also serves as an intermediate in the biosynthesis of gonadal steroid hormones and adrenal corticosteroids. Progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain a pregnancy. Progesterone shares the pharmacological actions of the progestins. Progesterone binds to the progesterone and estrogen receptors. Target cells include the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. Once bound to the receptor, progesterone will slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH (luteinizing hormone) surge. In women who have adequate endogenous estrogen, progesterone transforms a proliferative endometrium into a secretory one. Progesterone is metabolized primarily by the liver largely to pregnanediols and pregnanolones. Pregnanediols and pregnanolones are conjugated in the liver to glucuronide and sulfate metabolites. Progesterone metabolites that are excreted in the bile may be deconjugated and may be further metabolized in the gut via reduction, dehydroxylation, and epimerization. Common progesterone side effects may include: drowsiness, dizziness; breast pain; mood changes; headache; constipation, diarrhea, heartburn; bloating, swelling in your hands or feet; joint pain; hot flashes; or vaginal discharge. — NCATS
Clinical trial activity
386 trials · 332 clinical orgs · 25 marketing orgs
Earliest trial started Sep 1, 1987 (NCT00000466)
Timeline
1930s
- Jun 1, 1935
Evidence of US Marketing
1970s
1980s
- Jan 1, 1987
Earliest Phase 3 Sponsor(trial)
1990s
- Jan 1, 1992
Earliest Phase 1 Sponsor(trial)
- Jan 1, 1996
Earliest Phase 2 Sponsor(trial)
- May 13, 1997
Watson Pharmaceuticals — NDA Secondary Org
- Jul 31, 1997
Allergan — NDA Secondary Org
- Jul 31, 1997
Allergan — Marketing Organization
- Jul 31, 1997
SmithKline Beecham — NDA Secondary Org
- Jul 31, 1997
AbbVie — Marketing Organization
- May 14, 1998
Virtus Pharms — NDA Secondary Org
- May 14, 1998
Virtus Pharms — Marketing Organization
- Dec 16, 1998
AbbVie — NDA Secondary Org
2000s
- Apr 25, 2001
Fresenius — Marketing Organization
- Jun 21, 2007
Ferring — NDA Secondary Org
- Jun 22, 2009
Sankyo — Marketing Organization
- Jun 22, 2009
Lutipold — Marketing Organization
- Jun 22, 2009
Daiichi Sankyo — Marketing Organization
2010s
- Oct 28, 2010
Hikma — Marketing Organization
- Feb 29, 2012
Teva — Marketing Organization
- Sep 28, 2012
Sofgen Pharmaceuticals — Marketing Organization
- Aug 16, 2013
Bionpharma Inc — Marketing Organization
- Feb 28, 2017
Dr. Reddy's Laboratories — Marketing Organization
- Sep 7, 2017
Amneal Pharmaceuticals — Marketing Organization
- Oct 20, 2017
Sandoz — Marketing Organization
- Oct 20, 2017
Exeltis — Marketing Organization
- Oct 26, 2018
Eugia Pharma — Marketing Organization
- Oct 28, 2018
TherapeuticsMD — Marketing Organization
- Oct 28, 2018
Mayne Pharma — NDA Secondary Org
2020s
- Apr 29, 2020
Ferring — Marketing Organization
- Nov 21, 2023
Accord Research — Marketing Organization
Indications
Studied for
- Abnormalities, Drug-Induced · Phase 4
- Abortion, Habitual · Phase 4
- Abortion, Induced · Phase 4
- Abortion, Spontaneous · Phase 4
- Abortion, Threatened · Phase 4
- Adenomyosis · Phase 3
- Alcoholism · Phase 2/Phase 3
- Alzheimer Disease · Phase 3
- Amenorrhea · Phase 4
- Amniotic Fluid · Phase 3
- Angina, Unstable · Phase 3
- Anhedonia · Phase 4
- Arteriosclerosis · Phase 4
- Atherosclerosis · Phase 2
- Atrophic Vaginitis · Phase 2
- Bipolar Disorder · Phase 2
- Bone Diseases · Phase 3
- Brain Concussion · Phase 4
- Brain Injuries · Phase 3
- Brain Injuries, Traumatic · Phase 3
- Breast Neoplasms · Phase 4
- Bulimia Nervosa · Phase 2
- Cannabis · Phase 2
- Cardiovascular Diseases · Phase 4
- Cerebral Small Vessel Diseases · Phase 2
- Cervical Intraepithelial Neoplasia · Phase 2
- Cervix Uteri · Phase 3
- Cocaine-Related Disorders · Phase 2/Phase 3
- Cognitive Dysfunction · Phase 2
- Contraception · Phase 4
- Coronary Artery Disease · Phase 3
- Coronary Disease · Phase 3
- COVID-19 · Phase 2
- Cryopreservation · Phase 4
- Cystic Fibrosis · Phase 4
- Deficiency Diseases · Phase 2
- Delivery, Obstetric · Phase 4
- Depression · Phase 4
- Depression, Postpartum · Phase 2
- Diabetes Mellitus · Phase 3
- Disability Evaluation · Phase 2
- Dry Eye Syndromes · Phase 2
- Dydrogesterone · Phase 4
- Embryo Implantation · Phase 4
- Embryo Loss · Phase 3
- Embryo Transfer · Phase 4
- Endocrine System Diseases · Early Phase 1
- Endometrial Hyperplasia · Phase 2/Phase 3
- Endometrial Neoplasms · Phase 3
- Endometriosis · Phase 3
- Endometrium · Phase 4
- Endothelial Cells · Phase 2
- Epilepsy · Phase 3
- Estrogens · Phase 4
- Exercise · Phase 3
- Feeding and Eating Disorders · Phase 2
- Female · Phase 1
- Fertility · Phase 4
- Fertilization in Vitro · Phase 4
- Fetal Development · Phase 2
- Flushing · Phase 3
- Genital Diseases, Female · Phase 4
- Genital Diseases, Male · Phase 4
- Glioblastoma · Early Phase 1
- Gliosarcoma · Early Phase 1
- Gonadotropin-Releasing Hormone · Phase 3
- Graft vs Host Disease · Phase 2/Phase 3
- Growth and Development · Phase 2
- Healthy Volunteers · Phase 4
- Heart Defects, Congenital · Phase 2
- Heart Diseases · Phase 3
- HIV Infections · Phase 4
- Hormone Replacement Therapy · Phase 4
- Hormones · Phase 4
- Hormones, Hormone Substitutes, and Hormone Antagonists · Phase 4
- Hyperandrogenism · Phase 1
- Hypercholesterolemia · Phase 3
- Hypertension · Phase 3
- Infant, Premature · Phase 4
- Infertility · Phase 4
- Infertility, Female · Phase 4
- Infertility, Male · Phase 4
- Irritable Mood · Phase 4
- Jervell-Lange Nielsen Syndrome · Phase 2
- Leiomyoma · Phase 2
- Leukomalacia, Periventricular · Phase 2
- Long QT Syndrome · Phase 4
- Luteal Phase · Phase 4
- Major Depressive Disorder · Phase 4
- Male · Phase 4
- Mania · Phase 2
- Memory Disorders · Phase 3
- Menopause · Phase 4
- Menstrual Cycle · Early Phase 1
- Menstruation Disturbances · Phase 3
- Methamphetamine · Early Phase 1
- Morbidity · Phase 3
- Myocardial Ischemia · Phase 3
- Neonatology · Phase 3
- Neoplasms · Phase 2
- Obstetric Labor, Premature · Phase 4
- Orthostatic Intolerance · Phase 2
- Osteoporosis · Phase 4
- Ovarian Diseases · Early Phase 1
- Ovarian Hyperstimulation Syndrome · Phase 4
- Perimenopause · Phase 3
- Perinatal Mortality · Phase 3
- Pharmacogenetics · Phase 4
- Pharmacokinetics · Phase 4
- Physiological Effects of Drugs · Phase 4
- Physiology · Phase 1
- Placenta Previa · Phase 2
- Polycystic Ovary Syndrome · Phase 4
- Postmenopause · Phase 4
- Pre-Eclampsia · Phase 2/Phase 3
- Pregnancy · Phase 4
- Pregnancy Complications · Phase 4
- Pregnancy Trimester, Second · Phase 3
- Pregnancy, Twin · Phase 3
- Pregnancy, Unwanted · Phase 1/Phase 2
- Pregnant People · Phase 4
- Premature Birth · Phase 4
- Premenopause · Phase 4
- Premenstrual Syndrome · Phase 1
- Primary Ovarian Insufficiency · Phase 4
- Progesterone · Phase 4
- Progestins · Phase 4
- Prostheses and Implants · Phase 4
- Psychotic Disorders · Phase 4
- Puberty · Phase 1
- Reproduction · Phase 4
- Reproductive Health · Phase 4
- Reproductive Techniques, Assisted · Phase 4
- Sexual Abstinence · Early Phase 1
- Smoking · Phase 4
- Smoking Cessation · Phase 4
- Smoking Reduction · Phase 4
- Spermatozoa · Phase 3
- Stress Disorders, Post-Traumatic · Phase 2/Phase 3
- Stroke · Phase 4
- Substance Withdrawal Syndrome · Phase 4
- Suicidal Ideation · Phase 4
- Sweat · Phase 3
- Systems Biology · Phase 4
- Tendon Injuries · Phase 4
- Thoracic Surgery · Phase 2
- Thrombosis · Phase 3
- Tobacco Use Disorder · Phase 4
- Transgender Persons · Phase 4
- Transsexualism · Phase 4
- Traumatology · Phase 1
- Turner Syndrome · Phase 4
- Urinary Calculi · Phase 4
- Uterine Diseases · Phase 3
- Uterine Neoplasms · Phase 2
- Uterus · Phase 3
- Vaginal Diseases · Phase 2
- Vascular Diseases · Phase 2
- Vasomotor System · Phase 3
- Vulvar Lichen Sclerosus · Phase 2
- Weight Gain · Phase 4
- White Matter · Phase 2
Mechanism of action
- Progesterone receptorAGONIST
PGR agonist
Combination products
bijuva
with estradiol
Approval history
- approvedNov 1, 1974
- approvedJun 1, 1935
Chemistry & pharmacology
SMILES
CC(=O)[C@H]1CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@]12C- Mol. weight
- 314.4617 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral, Topical
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
Yes
Sources
- WikipediaProgesterone ↗
- NCATS4G7DS2Q64Y ↗
- ChEMBLCHEMBL103 ↗
Also known as
- 17alpha-progesterone
- 17alpha-progesterone
- 17α-progesterone
- 17α-progesterone
- 4-pregnene-3,20-dione
- 4-pregnene-3,20-dione
- agolutin
- agolutin
- akrolutin
- akrolutin
- corpus luteum hormone
- corpus luteum hormone
- crinone
- crinone
- crinone
- crinone
- cyclogest
- cyclogest
- delta(4)-pregnene-3,20-dione
- delta(4)-pregnene-3,20-dione
- dr-2011
- dr-2011
- endometrin
- endometrin
- fe 999913
- fe 999913
- gelbkoerperhormon
- gelbkoerperhormon
- gestone
- gestormone
- glanducorpin
- lugesteron
- lugesterone
- luteohormone
- luteohormone
- lutigest
- lutogynon
- lutogynon
- mestesterol
- pregn-4-ene-3,20-dione
- pregn-4-ene-3,20-dione
- prochieve
- prochieve
- progesta-care
- progestan
- progestasert
- progestasert
- progesterol
- progesteron
- progesteron
- progesterona
- progesterona
- progesterone
- progesterone
- progesterone
- progesterone
- progesterone
- progesterone
- progesterone
- progesterone
- progesterone
- progesterone
- progesterone
- progesterone
- progestérone
- progestérone
- progesteronum
- progesteronum
- progeston
- progestone
- progestron
- prometrium
- prometrium
- (s)-4-pregnene-3,20-dione
- (s)-4-pregnene-3,20-dione
- serenity for women
- (s)-pregn-4-en-3,20-dione
- (s)-pregn-4-en-3,20-dione
- (s)-progesterone
- (s)-progesterone
- syngesterone
- syngestrone
- utrogestan
- utrogestan
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06856174 | Phase 4 | Jan 19, 2026 | Exeltis, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Aging (NIA) |
| NCT07305519 | N/A | Jan 1, 2026 | University of Roma La Sapienza |
| NCT07136922 | Phase 1 | Dec 31, 2025 | Calla Lily Clinical Care Ltd, University of Warwick |
| NCT06631547 | Phase 1 | Dec 1, 2025 | Assiut University |
| NCT07173361 | Phase 1 | Sep 15, 2025 | McMaster University |
| NCT07162961 | Phase 3 | Sep 1, 2025 | Sun Yat-Sen University |
| NCT06851754 | Early Phase 1 (Phase 1) | Jul 17, 2025 | National Institutes of Health (NIH) |
| NCT06668896 | Phase 1 | Jun 30, 2025 | Daré Bioscience, Inc., National Institutes of Health (NIH) |
| NCT06928844 | N/A | Apr 15, 2025 | General Committee of Teaching Hospitals and Institutes, Egypt |
| NCT06875752 | Phase 4 | Apr 12, 2025 | Dunamenti REK Istenhegyi IVF Center, Szeged University, University of Pecs |
| NCT06807580 | Phase 2 | Mar 31, 2025 | Emory University |
| NCT06870266 | Early Phase 1 (Phase 1) | Mar 31, 2025 | Hebrew University |
| NCT06834594 | Phase 4 | Mar 13, 2025 | University of Kansas |
| NCT07264933 | N/A | Feb 12, 2025 | Benha University |
| NCT06896617 | Phase 4 | Feb 1, 2025 | University of Barcelona |
| NCT06644794 | Phase 3 | Dec 5, 2024 | Shandong University of Traditional Chinese Medicine |
| NCT06534255 | N/A | Oct 1, 2024 | Anhui Medical University, University of Science and Technology of China |
| NCT06572761 | Phase 3 | Sep 30, 2024 | Assistance Publique - Hôpitaux de Paris, Institut National de la Santé Et de la Recherche Médicale, France |
| NCT06610305 | Phase 4 | Sep 2, 2024 | National Institute of Mental Health (NIMH), University of North Carolina at Chapel Hill |
| NCT06463652 | N/A | Jun 26, 2024 | Ho Chi Minh City University of Medicine and Pharmacy, My Duc Phu Nhuan Hospital |
Organizations
Research & Development (332)
Marketing (34)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | NDA2 | Dec 16, 1998 |
| AbbVie | For profit | MKTG | Jul 31, 1997 |
| Accord Research | For profit | MKTG | Nov 21, 2023 |
| Actavis | For profit | NDA2 | May 11, 1978 |
| Allergan | For profit | NDA2 | Jul 31, 1997 |
| Allergan | For profit | MKTG | Jul 31, 1997 |
| Alza | For profit | NDA2 | Feb 4, 1976 |
| Alza | For profit | NDA | Feb 4, 1976 |
| Amneal Pharmaceuticals | For profit | SYN | May 16, 2022 |
| Amneal Pharmaceuticals | For profit | MKTG | Sep 7, 2017 |
| Bionpharma Inc | For profit | MKTG | Aug 16, 2013 |
| Bionpharma Inc | For profit | SYN | Aug 16, 2013 |
| Daiichi Sankyo | For profit | MKTG | Jun 22, 2009 |
| Dr. Reddy's Laboratories | For profit | MKTG | Feb 28, 2017 |
| Dr. Reddy's Laboratories | For profit | SYN | Feb 28, 2017 |
| Eli Lilly | For profit | MKTG | Nov 1, 1974 |
| Eli Lilly | For profit | NDA2 | Nov 1, 1974 |
| Eugia Pharma | For profit | MKTG | Oct 26, 2018 |
| Exeltis | For profit | MKTG | Oct 20, 2017 |
| Ferring | For profit | NDA2 | Jun 21, 2007 |
| Ferring | For profit | MKTG | Apr 29, 2020 |
| Fresenius | For profit | MKTG | Apr 25, 2001 |
| Hikma | For profit | MKTG | Oct 28, 2010 |
| Lutipold | For profit | MKTG | Jun 22, 2009 |
| Mayne Pharma | For profit | NDA2 | Oct 28, 2018 |
| Sandoz | For profit | MKTG | Oct 20, 2017 |
| Sankyo | For profit | MKTG | Jun 22, 2009 |
| SmithKline Beecham | For profit | NDA2 | Jul 31, 1997 |
| Sofgen Pharmaceuticals | For profit | MKTG | Sep 28, 2012 |
| Teva | For profit | MKTG | Feb 29, 2012 |
| TherapeuticsMD | For profit | MKTG | Oct 28, 2018 |
| Virtus Pharms | For profit | NDA2 | May 14, 1998 |
| Virtus Pharms | For profit | MKTG | May 14, 1998 |
| Watson Pharmaceuticals | For profit | NDA2 | May 13, 1997 |