Medroxyprogesterone acetate
Lunelle, 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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
| urogenital diseases | D000091642 |
| skin and connective tissue diseases | D017437 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Depo-provera, Depo-subq provera, Provera (generic drugs available since 1996-08-09, discontinued: Amen, Curretab, Cycrin)
CombinationsPremphase, Prempro (discontinued: Lunelle, Premphase (premarin;cycrin ), Prempro (premarin;cycrin))
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol cypionate
+
Medroxyprogesterone acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LUNELLE | Pharmacia & Upjohn | N-020874 DISCN | 2000-10-05 | 1 products |
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Estrogens
+
conjugated
+
Medroxyprogesterone acetate
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| depo-provera | New Drug Application | 2020-12-31 |
| medroxyprogesterone acetate | ANDA | 2022-10-12 |
| premphase prempro | New Drug Application | 2019-12-04 |
| provera | New Drug Application | 2021-12-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| amenorrhea | — | D000568 | N91.2 |
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| endometrial hyperplasia | — | D004714 | N85.0 |
| endometrial neoplasms | EFO_0004230 | D016889 | — |
| hypoventilation | HP_0002791 | D007040 | — |
| renal cell carcinoma | EFO_0000376 | D002292 | — |
| uterine hemorrhage | — | D014592 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
25 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | 1 | — | 1 |
| Cerebral palsy | D002547 | G80 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | — | — | 1 | — | 1 | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overweight | D050177 | E66.3 | — | 1 | — | — | — | 1 | |
| Exercise | D015444 | EFO_0000483 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | — | 2 | 2 |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 1 | 1 | |
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | — | 1 | 1 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | — | — | — | 1 | 1 |
| Pharmacokinetics | D010599 | — | — | — | — | 1 | 1 | ||
| Short bowel syndrome | D012778 | — | — | — | — | 1 | 1 | ||
| Healthy volunteers/patients | — | — | — | — | — | 1 | 1 | ||
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | — | 1 | 1 |
| Bone marrow transplantation | D016026 | — | — | — | — | 1 | 1 |
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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 | 1000112 |
| ChEMBL ID | CHEMBL717 |
| ChEBI ID | 6716 |
| PubChem CID | 6279 |
| DrugBank | DB00603 |
| UNII ID | HSU1C9YRES (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
No data
Financial
Provera - Pfizer
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,712 documents
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Safety
Black-box Warning
Black-box warning for: Depo-provera, Medroxyprogesterone acetate, Premphase prempro, Provera
Adverse Events
Top Adverse Reactions
0 adverse events reported
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