progesterone

Trade name: progestasert

Small moleculeapproved

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

Phase 1
46
Phase 2
115
Phase 3
79
Phase 4
108

Earliest trial started Sep 1, 1987 (NCT00000466)

Timeline

1930s

  1. Jun 1, 1935

    Evidence of US Marketing

1970s

  1. Nov 1, 1974

    Earliest FDA Approval

  2. Nov 1, 1974

    Eli Lilly — Marketing Organization

  3. Nov 1, 1974

    Eli Lilly — NDA Secondary Org

  4. Feb 4, 1976

    Alza — First NDA Organization

  5. Feb 4, 1976

    Alza — NDA Secondary Org

  6. Feb 4, 1976

    Alza — NDA Organization

  7. May 11, 1978

    Actavis — NDA Secondary Org

1980s

  1. Jan 1, 1987

    Earliest Phase 3 Sponsor(trial)

1990s

  1. Jan 1, 1992

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1996

    Earliest Phase 2 Sponsor(trial)

  3. May 13, 1997

    Watson Pharmaceuticals — NDA Secondary Org

  4. Jul 31, 1997

    Allergan — NDA Secondary Org

  5. Jul 31, 1997

    Allergan — Marketing Organization

  6. Jul 31, 1997

    SmithKline Beecham — NDA Secondary Org

  7. Jul 31, 1997

    AbbVie — Marketing Organization

  8. May 14, 1998

    Virtus Pharms — NDA Secondary Org

  9. May 14, 1998

    Virtus Pharms — Marketing Organization

  10. Dec 16, 1998

    AbbVie — NDA Secondary Org

2000s

  1. Apr 25, 2001

    Fresenius — Marketing Organization

  2. Jun 21, 2007

    Ferring — NDA Secondary Org

  3. Jun 22, 2009

    Sankyo — Marketing Organization

  4. Jun 22, 2009

    Lutipold — Marketing Organization

  5. Jun 22, 2009

    Daiichi Sankyo — Marketing Organization

2010s

  1. Oct 28, 2010

    Hikma — Marketing Organization

  2. Feb 29, 2012

    Teva — Marketing Organization

  3. Sep 28, 2012

    Sofgen Pharmaceuticals — Marketing Organization

  4. Aug 16, 2013

    Bionpharma Inc — Marketing Organization

  5. Feb 28, 2017

    Dr. Reddy's Laboratories — Marketing Organization

  6. Sep 7, 2017

    Amneal Pharmaceuticals — Marketing Organization

  7. Oct 20, 2017

    Sandoz — Marketing Organization

  8. Oct 20, 2017

    Exeltis — Marketing Organization

  9. Oct 26, 2018

    Eugia Pharma — Marketing Organization

  10. Oct 28, 2018

    TherapeuticsMD — Marketing Organization

  11. Oct 28, 2018

    Mayne Pharma — NDA Secondary Org

2020s

  1. Apr 29, 2020

    Ferring — Marketing Organization

  2. Nov 21, 2023

    Accord Research — Marketing Organization

Indications

Studied for

Mechanism of action

Combination products

Approval history

  • approvedNov 1, 1974
  • approvedJun 1, 1935

Chemistry & pharmacology

Loading structure…

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

Black box warning

Sources

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 IDPhaseStart dateSponsor(s)
NCT06856174Phase 4Jan 19, 2026Exeltis, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Aging (NIA)
NCT07305519N/AJan 1, 2026University of Roma La Sapienza
NCT07136922Phase 1Dec 31, 2025Calla Lily Clinical Care Ltd, University of Warwick
NCT06631547Phase 1Dec 1, 2025Assiut University
NCT07173361Phase 1Sep 15, 2025McMaster University
NCT07162961Phase 3Sep 1, 2025Sun Yat-Sen University
NCT06851754Early Phase 1 (Phase 1)Jul 17, 2025National Institutes of Health (NIH)
NCT06668896Phase 1Jun 30, 2025Daré Bioscience, Inc., National Institutes of Health (NIH)
NCT06928844N/AApr 15, 2025General Committee of Teaching Hospitals and Institutes, Egypt
NCT06875752Phase 4Apr 12, 2025Dunamenti REK Istenhegyi IVF Center, Szeged University, University of Pecs
NCT06807580Phase 2Mar 31, 2025Emory University
NCT06870266Early Phase 1 (Phase 1)Mar 31, 2025Hebrew University
NCT06834594Phase 4Mar 13, 2025University of Kansas
NCT07264933N/AFeb 12, 2025Benha University
NCT06896617Phase 4Feb 1, 2025University of Barcelona
NCT06644794Phase 3Dec 5, 2024Shandong University of Traditional Chinese Medicine
NCT06534255N/AOct 1, 2024Anhui Medical University, University of Science and Technology of China
NCT06572761Phase 3Sep 30, 2024Assistance Publique - Hôpitaux de Paris, Institut National de la Santé Et de la Recherche Médicale, France
NCT06610305Phase 4Sep 2, 2024National Institute of Mental Health (NIMH), University of North Carolina at Chapel Hill
NCT06463652N/AJun 26, 2024Ho Chi Minh City University of Medicine and Pharmacy, My Duc Phu Nhuan Hospital
Showing 20 of 386 trials
Page 1 / 20

Organizations

Research & Development (332)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institutes of Health (NIH)Government28251987
National Institute of Mental Health (NIMH)Government13341992
Harvard UniversityAcademic/Hospital12942000
University of VirginiaAcademic/Hospital121132000
FerringFor profit11642005
National Institute on Drug Abuse (NIDA)Government11151999
Free University of BrusselsAcademic/Hospital101032005
University of North Carolina at Chapel HillAcademic/Hospital101032013
Yale UniversityAcademic/Hospital10752004
Assiut UniversityAcademic/Hospital9952012
IBSA Institut Biochimique SAFor profit9832005
Ain Shams UniversityAcademic/Hospital8742009
University of MinnesotaAcademic/Hospital8731999
National Heart, Lung, and Blood Institute (NHLBI)Government7441987
National Institute on Aging (NIA)Government7141987
Sun Yat-Sen UniversityAcademic/Hospital7532010
Tel Aviv UniversityAcademic/Hospital6552009
Thomas Jefferson UniversityAcademic/Hospital6542000
University of ValenciaAcademic/Hospital6622006
Cairo UniversityAcademic/Hospital5532013
332 organizations
Page 1 / 17

Marketing (34)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Dec 16, 1998
AbbVieFor profitMKTGJul 31, 1997
Accord ResearchFor profitMKTGNov 21, 2023
ActavisFor profitNDA2May 11, 1978
AllerganFor profitNDA2Jul 31, 1997
AllerganFor profitMKTGJul 31, 1997
AlzaFor profitNDA2Feb 4, 1976
AlzaFor profitNDAFeb 4, 1976
Amneal PharmaceuticalsFor profitSYNMay 16, 2022
Amneal PharmaceuticalsFor profitMKTGSep 7, 2017
Bionpharma IncFor profitMKTGAug 16, 2013
Bionpharma IncFor profitSYNAug 16, 2013
Daiichi SankyoFor profitMKTGJun 22, 2009
Dr. Reddy's LaboratoriesFor profitMKTGFeb 28, 2017
Dr. Reddy's LaboratoriesFor profitSYNFeb 28, 2017
Eli LillyFor profitMKTGNov 1, 1974
Eli LillyFor profitNDA2Nov 1, 1974
Eugia PharmaFor profitMKTGOct 26, 2018
ExeltisFor profitMKTGOct 20, 2017
FerringFor profitNDA2Jun 21, 2007
FerringFor profitMKTGApr 29, 2020
FreseniusFor profitMKTGApr 25, 2001
HikmaFor profitMKTGOct 28, 2010
LutipoldFor profitMKTGJun 22, 2009
Mayne PharmaFor profitNDA2Oct 28, 2018
SandozFor profitMKTGOct 20, 2017
SankyoFor profitMKTGJun 22, 2009
SmithKline BeechamFor profitNDA2Jul 31, 1997
Sofgen PharmaceuticalsFor profitMKTGSep 28, 2012
TevaFor profitMKTGFeb 29, 2012
TherapeuticsMDFor profitMKTGOct 28, 2018
Virtus PharmsFor profitNDA2May 14, 1998
Virtus PharmsFor profitMKTGMay 14, 1998
Watson PharmaceuticalsFor profitNDA2May 13, 1997