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 .
Background
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 |
---|---|---|---|---|---|
2024/10/08 | 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 | |||
2023/08/01 | Phase 1 | Recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
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 | |
RPK Pharmaceuticals, Inc. | 53002-2760 | ORAL | 200 mg in 1 1 | 6/6/2022 |
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 |
---|---|---|---|---|---|
Progesterone Soft Capsules | 国药准字H20254199 | 化学药品 | 胶囊剂 | 5/20/2025 | |
Progesterone Soft Capsules | 国药准字H20254198 | 化学药品 | 胶囊剂 | 5/20/2025 | |
Progesterone Soft Capsules | 国药准字H20254091 | 化学药品 | 胶囊剂 | 5/13/2025 | |
Progesterone Soft Capsules | 国药准字H20254090 | 化学药品 | 胶囊剂 | 5/13/2025 | |
Progesterone Injection(II) | 国药准字H20253626 | 化学药品 | 注射剂 | 3/18/2025 | |
Progesterone Injection(II) | 国药准字H20244091 | 化学药品 | 注射剂 | 6/18/2024 | |
Progesterone Injection | 国药准字H42021920 | 化学药品 | 注射剂 | 7/6/2022 | |
Progesterone Injection | 国药准字H41021493 | 化学药品 | 注射剂 | 6/5/2020 | |
Progesterone Injection | 国药准字H20205021 | 化学药品 | 注射剂 | 8/20/2020 | |
Progesterone Injection | 国药准字H53020916 | 化学药品 | 注射剂 | 9/28/2020 |
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 |
---|---|---|---|---|---|
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 | |
ENDOMETRIN PESSARIES progesterone 100mg vaginal tablet blister pack | 189948 | Medicine | A | 9/19/2012 | |
PROMETRIUM 200 progesterone 200 mg soft capsule blister pack | 232823 | Medicine | A | 6/20/2016 | |
BIJUVA 1/100 estradiol (as hemihydrate) 1 mg progesterone 100 mg capsule blister pack | 367690 | Medicine | A | 5/3/2022 |