Overview
Progesterone is a hormone that occurs naturally in females, and is essential for endometrial receptivity, embryo implantation, and the successful establishment of pregnancy. A low progesterone concentration or an insufficient response to progesterone can cause infertility and pregnancy loss . Progesterone is used in various contraceptive preparations to prevent ovulation and fertilization , as well as in other formulations to promote and support pregnancy. Please see Medroxyprogesterone acetate, Megestrol acetate, Dydrogesterone and Hydroxyprogesterone entries for information on various other forms of progesterone. Pharmaceutical progesterone is made from a plant source as a starting material and is chemically identical to progesterone of human ovarian origin . Progesterone is available in gelatinized capsule form, vaginal gel form, tablet form, vaginal insert form, and injection form, all used for various purposes .
Indication
Gelatinized capsules The gelatinized capsules are indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea . Vaginal gel Progesterone gel (8%) is indicated as progesterone supplementation or replacement as part of an Assisted Reproductive Technology (“ART”) treatment for infertile women with progesterone deficiency. The lower concentration progesterone gel (4%) is used in the treatment of secondary amenorrhea, with the use of the 8% concentration if there is no therapeutic response to the 4% gel . Vaginal insert This form is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women . Injection (intramuscular) This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer . Tablets, contraceptive The tablet form of progesterone in contraceptive formulations is indicated for the prevention of pregnancy .
Associated Conditions
- Abnormal Uterine Bleeding
- Amenorrhea
- Endometrial hyperplasia caused by conjugated estrogen
- Moderate to Severe Vasomotor Symptoms
- Pregnancy
- Secondary Amenorrhea
- Recurrent spontaneous preterm birth
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/16 | Not Applicable | Active, not recruiting | Dr. Soetomo General Hospital | ||
2025/04/15 | Not Applicable | Recruiting | The General Authority for Teaching Hospitals and Institutes | ||
2025/03/13 | Phase 4 | Recruiting | Dunamenti REK Istenhegyi IVF Center | ||
2025/03/11 | Early Phase 1 | Not yet recruiting | |||
2025/03/04 | Phase 4 | Not yet recruiting | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | ||
2025/02/28 | Early Phase 1 | Recruiting | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||
2025/02/19 | Phase 4 | Not yet recruiting | Children's Mercy Hospital Kansas City | ||
2025/02/06 | N/A | Completed | El Shatby University Hospital for Obstetrics and Gynecology | ||
2025/02/04 | Phase 2 | Recruiting | |||
2024/11/01 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 71335-1990 | ORAL | 200 mg in 1 1 | 1/8/2021 | |
| Bryant Ranch Prepack | 71335-1443 | ORAL | 100 mg in 1 1 | 5/20/2021 | |
| Dr. Donna Restivo DC | 62185-0050 | ORAL | 8 [hp_X] in 1 mL | 5/23/2025 | |
| West-Ward Pharmaceuticals Corp | 0143-9725 | INTRAMUSCULAR | 50 mg in 1 1 | 9/17/2018 | |
| Columbia Laboratories, Inc. | 55056-0818 | VAGINAL | 90 mg in 1.125 g | 11/19/2009 | |
| Asclemed USA, Inc. | 76420-282 | ORAL | 200 mg in 1 1 | 9/15/2022 | |
| Asclemed USA, Inc. | 76420-058 | ORAL | 100 mg in 1 1 | 10/12/2022 | |
| BioActive Nutritional, Inc. | 43857-0103 | ORAL | 6 [hp_X] in 1 mL | 5/20/2025 | |
| Sincerus Florida, LLC | 72934-4149 | TOPICAL | 0.1 g in 100 g | 5/6/2019 | |
| A-S Medication Solutions | 50090-6835 | ORAL | 100 mg in 1 1 | 4/12/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ENDOMETRIN VAGINAL TABLETS 100 MG | SIN15005P | TABLET, EFFERVESCENT | 100.0 mg | 5/12/2016 | |
| UTROGESTAN CAPSULE 100 mg (White) | SIN11437P | CAPSULE, LIQUID FILLED | 100 mg | 12/19/2000 | |
| CYCLOGEST PESSARY 400 mg | SIN03626P | SUPPOSITORY | 400 mg | 7/26/1989 | |
| CRINONE PROGESTERONE VAGINAL GEL 8% | SIN10884P | GEL | 8% | 4/21/1999 | |
| UTROGESTAN CAPSULE 200mg | SIN15475P | CAPSULE, LIQUID FILLED | 200mg | 4/30/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ZESBINA 100 CAPSULES 100MG | N/A | N/A | N/A | 2/15/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| UTROGESTAN 200 progesterone 200 mg soft vaginal capsule blister pack | 232824 | Medicine | A | 7/12/2016 | |
| PROLUTEX progesterone 25 mg/1.112 mL solution for injection vial | 393324 | Medicine | A | 9/13/2023 | |
| CYCLOGEST progesterone 400 mg pessary strip pack | 348691 | Medicine | A | 2/11/2022 | |
| ORIPRO progesterone 100 mg pessary jar | 21190 | Medicine | A | 10/8/1991 | |
| MediHerb Capsella Complex Oral Liquid | 18568 | Medicine | A | 9/30/1991 | |
| PROMETRIUM 100 progesterone 100 mg soft capsule blister pack | 232818 | Medicine | A | 6/20/2016 | |
| Calm Oral Liquid | 492207 | Medicine | A | 6/19/2025 | |
| Calm Oral Liquid | 455427 | Medicine | A | 7/16/2024 | |
| UTROGESTAN 400 progesterone 400 mg soft vaginal capsule blister pack | 483866 | Medicine | A | 7/2/2025 | |
| UTROGESTAN 300 progesterone 300 mg soft vaginal capsule blister pack | 483865 | Medicine | A | 7/2/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CRINONE | emd serono, a division of emd inc., canada | 02241013 | Gel - Vaginal | 8 % | 5/20/2000 |
| INPROSUB | 02515504 | Solution - Subcutaneous | 25 MG / 1.112 ML | N/A | |
| ESTROGEL PROPAK | Merck Canada Inc | 02403404 | Metered-Dose Pump
,
Capsule - Transdermal
,
Oral | 100 MG / CAP | 4/8/2013 |
| BIJUVA | knight therapeutics inc. | 02505223 | Capsule - Oral | 100 MG | 1/31/2024 |
| TEVA-PROGESTERONE | teva canada limited | 02439913 | Capsule - Oral | 100 MG | 4/16/2015 |
| PROGESTERONE INJECTION, USP | hikma canada limited | 02531828 | Solution - Intramuscular | 50 MG / ML | 4/28/2023 |
| AURO-PROGESTERONE | auro pharma inc | 02493578 | Capsule - Oral | 100 MG | 3/16/2020 |
| UTROGESTAN | besins healthcare sa | 02462818 | Capsule - Vaginal | 200 MG | N/A |
| REDDY-PROGESTERONE | 02463113 | Capsule - Oral | 100 MG | 8/9/2018 | |
| EUGIA-PROGESTERONE | eugia pharma inc. | 02546493 | Capsule - Oral | 100 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| GEPRETIX 200 MG CAPSULAS BLANDAS EFG | Exeltis Healthcare S.L. | 87949 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| PROLUTEX 25 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA | Ibsa Farmaceutici Italia S.R.L. | 89065 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Not Commercialized |
| UTROGESTAN 300 MG CAPSULAS VAGINALES BLANDAS | Besins Healthcare Ireland Limited | 88928 | CÁPSULA VAGINAL BLANDA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| DARSTIN 10 mg/g GEL | Seid S.A. | 55868 | GEL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| PROGEFFIK 200 MG CAPSULAS BLANDAS | Laboratorios Effik Sociedade Unipessoal Lda. | 5352265IP | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GEPRETIX 100 MG CAPSULAS BLANDAS EFG | Exeltis Healthcare S.L. | 87948 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| CRINONE 8% GEL VAGINAL | Merck S.L. | 62915 | GEL VAGINAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| PROLUTEX 25 MG SOLUCION INYECTABLE | Ibsa Farmaceutici Italia S.R.L. | 78108 | SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Commercialized |
| SEIDIGESTAN 200 mg cápsulas blandas | Seid S.A. | 64899 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| PROGEFFIK 200 mg CAPSULAS BLANDAS | Laboratorios Effik S.A. | 64560 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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