Medroxyprogesterone acetate
Lunelle, Medroxyprogesterone, Premphase, Prempro, Provera (medroxyprogesterone acetate) is a small molecule pharmaceutical. Medroxyprogesterone acetate was first approved as Provera on 1982-01-01. It is used to treat amenorrhea, breast neoplasms, endometrial hyperplasia, endometrial neoplasms, and hypoventilation amongst others in the USA. The pharmaceutical is active against progesterone receptor.
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Commercial
Trade Name
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Depo-provera, Depo-subq provera, Medroxyprogesterone, Provera (discontinued: Amen, Curretab, Depo-provera, Medroxyprogesterone)
CombinationsPrempro (discontinued: Lunelle, Premphase (premarin;cycrin ))
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Medroxyprogesterone acetate
Estradiol cypionate
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Medroxyprogesterone acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LUNELLE | Pharmacia & Upjohn | N-020874 DISCN | 2000-10-05 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| depo-provera | New Drug Application | 2024-07-26 |
| depo-subq provera | New Drug Application | 2024-07-24 |
| depo-subq provera 104 | 2006-05-23 | |
| medroxyprogesterone | ANDA | 2022-10-09 |
| medroxyprogesterone acetate | ANDA | 2024-10-09 |
| medroxyprogesterone acetate injectable suspension | ANDA | 2023-01-19 |
| premphase | ANDA | 2012-11-26 |
| premphase prempro | New Drug Application | 2024-02-20 |
| prempro | New Drug Application | 2021-02-05 |
| provera | New Drug Application | 2024-08-30 |
Indications
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Agency Specific
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ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03A: Hormonal contraceptives for systemic use
— G03AA: Progestogens and estrogen systemic contraceptives, fixed combinations
— G03AA08: Medroxyprogesterone and ethinylestradiol
— G03AA17: Medroxyprogesterone and estradiol
— G03AC: Progestogen systemic hormonal contraceptives
— G03AC06: Medroxyprogesterone
— G03D: Progestogen sex hormones and modulators of the genital system
— G03DA: Pregnen (4) derivatives, progestogens
— G03DA02: Medroxyprogesterone
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA12: Medroxyprogesterone and estrogen
— G03FB: Progestogens and estrogens, sequential preparations
— G03FB06: Medroxyprogesterone and estrogen
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02A: Hormones and related agents
— L02AB: Progestogens, endocrine therapy drugs
— L02AB02: Medroxyprogesterone
HCPCS
Code | Description |
|---|---|
| J1050 | Injection, medroxyprogesterone acetate, 1 mg |
Clinical
Clinical Trials
224 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | — | — | 14 | 4 | 1 | 12 | 19 | 47 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 13 | 4 | 1 | 4 | 20 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 3 | — | 2 | 8 | 16 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 1 | 4 | 2 | 5 | 12 |
| Uterine hemorrhage | D014592 | — | — | 1 | 1 | 3 | 2 | 4 | 10 |
| Infertility | D007246 | HP_0000789 | — | — | — | 2 | 4 | 4 | 10 |
| Postmenopause | D017698 | — | — | 3 | 1 | 4 | 1 | 1 | 10 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 2 | 4 | 2 | 2 | 9 |
| Endometrial hyperplasia | D004714 | — | N85.0 | 1 | 5 | 2 | 2 | — | 8 |
| Hyperplasia | D006965 | EFO_0000536 | — | 1 | 5 | 2 | 2 | — | 8 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometrioid carcinoma | D018269 | — | — | 1 | 3 | 1 | — | 3 | 7 |
| Syndrome | D013577 | — | — | — | 1 | 1 | — | 4 | 6 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | 4 | — | 2 | 6 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 6 | — | — | 6 |
| Menopause | D008593 | EFO_0003922 | N95 | — | 3 | 2 | — | — | 5 |
| Carcinoma | D002277 | — | C80.0 | — | 4 | 1 | — | — | 5 |
| Coronary disease | D003327 | — | — | — | 1 | 5 | — | — | 5 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 1 | 5 | — | — | 5 |
| Healthy volunteers/patients | — | — | — | 3 | 1 | 1 | — | — | 4 |
| Adenocarcinoma | D000230 | — | — | 1 | 2 | 1 | — | — | 4 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | 2 | 3 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 1 | — | — | — | 1 |
| Prehypertension | D058246 | — | — | — | 1 | — | — | — | 1 |
| Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | 1 | — | — | — | 1 |
| Recurrence | D012008 | — | — | — | 1 | — | — | — | 1 |
| Adenosquamous carcinoma | D018196 | — | — | — | 1 | — | — | — | 1 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 1 | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | — | 1 |
| Preleukemia | D011289 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception behavior | D003268 | — | — | 1 | — | — | — | 5 | 6 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 2 | — | — | — | 1 | 3 |
| Emergencies | D004630 | — | — | 1 | — | — | — | 1 | 2 |
| Postcoital contraception | D044363 | — | — | 1 | — | — | — | 1 | 2 |
| Kidney transplantation | D016030 | — | — | 1 | — | — | — | — | 1 |
| Immunosuppression therapy | D007165 | — | — | 1 | — | — | — | — | 1 |
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | — | 1 |
| Estrogen replacement therapy | D015914 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 3 | 3 |
| Fertility | D005298 | — | — | — | — | — | — | 2 | 2 |
| Tissue adhesions | D000267 | — | — | — | — | — | — | 2 | 2 |
| Body weight changes | D001836 | — | — | — | — | — | — | 2 | 2 |
| Weight loss | D015431 | HP_0001824 | — | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 2 | 2 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | — | — | 2 | 2 |
| Fertility preservation | D059247 | — | — | — | — | — | — | 2 | 2 |
| Female infertility | D007247 | EFO_0008560 | N97 | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Medroxyprogesterone acetate |
| INN | medroxyprogesterone |
| Description | Medroxyprogesterone acetate is an acetate ester resulting from the formal condensation of the 17alpha-hydroxy group of medroxyprogesterone with the carboxy group of acetic acid. A widely used progestin in menopausal hormone therapy and in progestogen-only birth control. It has a role as a progestin, an androgen, a female contraceptive drug, a synthetic oral contraceptive, an adjuvant, an inhibitor, an antioxidant and an antineoplastic agent. It is a steroid ester, an acetate ester, a 20-oxo steroid, a 3-oxo-Delta(4) steroid and a corticosteroid. It is functionally related to a medroxyprogesterone. |
| Classification | Small molecule |
| Drug class | progestins; steroids (androgens, anabolics); antiandrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)CC[C@]4(C)[C@H]3CC[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 71-58-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL717 |
| ChEBI ID | 6716 |
| PubChem CID | 6279 |
| DrugBank | DB00603 |
| UNII ID | HSU1C9YRES (ChemIDplus, GSRS) |
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Provera – Pfizer
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Medroxyprogesterone acetate
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Estradiol
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Medroxyprogesterone
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Medroxyprogesterone acetate
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Medroxyprogesterone
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Safety
Black-box Warning
Black-box warning for: Depo-provera, Depo-subq provera, Depo-subq provera 104, Medroxyprogesterone acetate, Medroxyprogesterone acetate injectable suspension, Premphase, Premphase prempro, Prempro, Provera
Adverse Events
Top Adverse Reactions
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56,834 adverse events reported
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