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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/01 | Phase 1 | Not yet recruiting | |||
2024/10/08 | Phase 1 | Not yet recruiting | |||
2024/09/24 | Phase 4 | Recruiting | |||
2024/08/27 | Phase 3 | Not yet recruiting | |||
2024/06/18 | Not Applicable | Recruiting | Mỹ Đức Hospital | ||
2023/10/19 | Phase 3 | Completed | |||
2023/08/22 | Not Applicable | Recruiting | Nanjing University | ||
2023/08/18 | Phase 4 | Recruiting | |||
2023/08/08 | Phase 2 | Not yet recruiting | Beijing Tiantan Hospital | ||
2023/08/07 | Phase 1 | Recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-6835 | ORAL | 100 mg in 1 1 | 4/12/2021 | |
| Direct Rx | 72189-347 | ORAL | 200 mg in 1 1 | 4/27/2022 | |
| Actavis Pharma, Inc. | 0591-3128 | INTRAMUSCULAR | 50 mg in 1 mL | 10/5/2022 | |
| Columbia Laboratories, Inc. | 55056-0806 | VAGINAL | 90 mg in 1.125 g | 11/19/2009 | |
| Bryant Ranch Prepack | 71335-1432 | ORAL | 200 mg in 1 1 | 7/14/2023 | |
| Mayne Pharma | 68308-751 | ORAL | 100 mg in 1 1 | 11/28/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-2768 | ORAL | 100 mg in 1 1 | 6/15/2023 | |
| Proficient Rx LP | 71205-669 | ORAL | 200 mg in 1 1 | 6/1/2022 | |
| Banner Pharmacaps | 10888-7136 | ORAL | 200 mg in 1 1 | 11/22/2013 | |
| NuCare Pharmaceuticals,Inc. | 68071-2770 | ORAL | 200 mg in 1 1 | 7/15/2022 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ProFeme | 329700 | Medicine | A | 2/10/2020 | |
| PROGESTERONE PESSARIES 50MG Jar | 21194 | Medicine | A | 10/8/1991 | |
| ORIPRO progesterone 200 mg pessary strip pack | 165112 | Medicine | A | 10/20/2009 | |
| PROGESTERONE PESSARIES 25MG Jar | 21191 | Medicine | A | 10/8/1991 | |
| ORIPRO progesterone 100 mg pessary strip pack | 165111 | Medicine | A | 10/20/2009 | |
| BRAUER CALM Oral Spray | 65600 | Medicine | A | 7/31/1998 | |
| UTROGESTAN 300 progesterone 300 mg soft vaginal capsule bottle | 404350 | Medicine | A | 8/12/2024 | |
| UTROGESTAN 400 progesterone 400 mg soft vaginal capsule bottle | 404382 | Medicine | A | 8/12/2024 | |
| PROLUTEX progesterone 25 mg/1.112 mL solution for injection vial | 456005 | Medicine | A | 12/12/2024 | |
| CRINONE 8% progesterone 90mg/1.125g gel tube | 83166 | Medicine | A | 9/25/2002 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PROMETRIUM | organon canada inc. | 02166704 | Capsule - Oral | 100 MG | 12/31/1995 |
| PROGESTERONE INJ 50MG/ML USP | cytex pharmaceuticals inc | 01977652 | Liquid - Intramuscular | 50 MG / ML | 12/31/1992 |
| BIJUVA | knight therapeutics inc. | 02505215 | Capsule - Oral | 100 MG | N/A |
| M-PROGESTERONE | mantra pharma inc | 02551268 | Capsule - Oral | 100 MG | N/A |
| PMS-PROGESTERONE | 02480247 | Capsule - Oral | 200 MG | 2/7/2019 | |
| ACH-PROGESTERONE | 02549158 | Capsule - Oral | 100 MG | N/A | |
| ACT PROGESTERONE INJECTION | teva canada limited | 02446820 | Solution - Intramuscular | 50 MG / ML | 4/13/2016 |
| PMS-PROGESTERONE INJ 50MG/ML USP | 00739952 | Liquid - Intramuscular | 50 MG / ML | 12/31/1989 | |
| PROGESTERONE | sanis health inc | 02516187 | Capsule - Oral | 100 MG | 8/19/2022 |
| PMS-PROGESTERONE | 02476576 | Capsule - Oral | 100 MG | 8/8/2018 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| BIJUVA 1 MG/100 MG CAPSULAS BLANDAS | 85988 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| PROGEFFIK 100 mg CAPSULAS BLANDAS | Laboratorios Effik S.A. | 60879 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| CYCLOGEST 400 MG OVULOS | 82250 | ÓVULO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| SEIDIGESTAN 100 mg cápsulas blandas | Seid S.A. | 60814 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| PROGEFFIK 200 MG CAPSULAS BLANDAS | Laboratorios Effik Sociedade Unipessoal Lda. | 5352265 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| UTROGESTAN 200 MG CAPSULAS VAGINALES BLANDAS | Besins Healthcare Ireland Limited | 88298 | CÁPSULA VAGINAL BLANDA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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