Overview
Medroxyprogesterone acetate (MPA) is a progesterone derivative that is more resistant to metabolism for improved pharmacokinetic properties. MPA can be use to treat secondary amenorrhea, endometrial hyperplasia, abnormal uterine bleeding, osteoporosis, vasomotor symptoms in menopause, vulvar and vaginal atrophy, prevent pregnancy, manage pain in endometriosis, prevent pregnancy, and is also used in palliative care for endometrial and renal carcinoma. Medroxyprogesterone acetate was granted FDA approval on 18 June 1959.
Indication
Medroxyprogesterone acetate (MPA) oral tablets are indicated to treat secondary amenorrhea, reduce the incidence of endometrial hyperplasia in postmenopausal women, and to treat abnormal uterine bleeding due to hormonal imbalance, not organic pathology. Oral tablets containing MPA and conjugated estrogens are indicated to prevent postmenopausal osteoporosis and to treat moderate to severe menopausal symptoms such as vasomotor symptoms, vulvar atrophy, and vaginal atrophy. Subcutaneous MPA is indicated to prevent pregnancy and manage pain associated with endometriosis. Intramuscular MPA is indicated to prevent pregnancy, and at higher concentrations for palliative treatment of endometrial or renal carcinoma.
Associated Conditions
- Abnormal Uterine Bleeding
- Amenorrhea
- Endometrial Hyperplasia
- Endometriosis related pain
- Metastatic Renal Cell Carcinoma ( mRCC)
- Osteoporosis
- Pain
- Postmenopausal Osteoporosis
- Pregnancy
- Vasomotor Symptoms Associated With Menopause
- Vulvo Vaginal Atrophy
- Metastatic Endometrial carcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/01 | Phase 3 | Not yet recruiting | |||
2023/02/01 | N/A | Recruiting | Third Affiliated Hospital, Sun Yat-Sen University | ||
2022/12/30 | Phase 2 | Active, not recruiting | |||
2022/12/15 | Phase 4 | Recruiting | |||
2022/04/13 | Phase 3 | Not yet recruiting | ShangHai Ji Ai Genetics & IVF Institute | ||
2022/02/24 | Phase 2 | Recruiting | Leiden University Medical Center | ||
2020/12/23 | Phase 1 | Completed | |||
2020/12/04 | Phase 4 | UNKNOWN | Casa di Cura Privata Villa Mafalda | ||
2019/02/18 | Phase 4 | Terminated | |||
2018/10/09 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| REMEDYREPACK INC. | 52125-915 | INTRAMUSCULAR | 150 mg in 1 mL | 8/14/2018 | |
| Greenstone LLC | 59762-0055 | ORAL | 2.5 mg in 1 1 | 3/22/2024 | |
| Mylan Pharmaceuticals Inc. | 59762-0055 | ORAL | 2.5 mg in 1 1 | 3/22/2024 | |
| Aidarex Pharmaceuticals LLC | 33261-609 | ORAL | 2.5 mg in 1 1 | 1/13/2014 | |
| Amphastar Pharmaceuticals, Inc. | 0548-5410 | INTRAMUSCULAR | 150 mg in 1 mL | 4/16/2019 | |
| Prasco Laboratories | 66993-370 | INTRAMUSCULAR | 150 mg in 1 mL | 10/21/2021 | |
| Amneal Pharmaceuticals LLC | 70121-1480 | INTRAMUSCULAR | 150 mg in 1 mL | 6/13/2023 | |
| Bryant Ranch Prepack | 63629-8744 | INTRAMUSCULAR | 150 mg in 1 mL | 8/24/2021 | |
| REMEDYREPACK INC. | 70518-3070 | ORAL | 10 mg in 1 1 | 3/11/2024 | |
| RedPharm Drug, Inc. | 67296-0396 | ORAL | 10 mg in 1 1 | 1/19/2022 |
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 |
|---|---|---|---|---|---|
| PROVERA TABLET 10 mg | SIN03841P | TABLET | 10 mg | 2/10/1990 | |
| DEPO-PROVERA STERILE AQUEOUS SUSPENSION 50 mg/ml | SIN04540P | INJECTION | 50 mg/ml | 5/29/1990 | |
| PROVERA TABLET 5 mg | SIN10513P | TABLET | 5 mg | 12/3/1998 |
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 |
|---|---|---|---|---|---|
| PROVERA TAB 5 MG | N/A | N/A | N/A | 8/15/1978 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Provera tablet 500mg | 12336 | Medicine | A | 8/2/1991 | |
| Provera tablet 100mg | 12331 | Medicine | A | 8/2/1991 | |
| RALOVERA Medroxyprogesterone acetate 5mg tablet | 46531 | Medicine | A | 10/14/1993 | |
| SAYANA PRESS medroxyprogesterone acetate 104 mg/0.65 mL suspension for injection ampoule with attached needle | 401897 | Medicine | A | 8/9/2023 | |
| RALOVERA Medroxyprogesterone acetate 10mg tablet | 46532 | Medicine | A | 10/14/1993 | |
| DEPO-PROVERA medroxyprogesterone acetate 150 mg/1 mL suspension for injection pre-filled syringe | 401610 | Medicine | A | 5/3/2023 | |
| PROVERA Medroxyprogesterone acetate 2.5mg tablet | 42932 | Medicine | A | 1/7/1993 | |
| DEPROCIP medroxyprogesterone acetate 150 mg/1 mL injection suspension vial | 318838 | Medicine | A | 5/13/2020 | |
| DEPO-PROVERA medroxyprogesterone acetate 150 mg/mL aqueous suspension injection vial | 12300 | Medicine | A | 8/2/1991 | |
| Provera tablet 250mg | 12334 | Medicine | A | 8/2/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PREMPLUS | 02242879 | Kit
,
Tablet - Oral | 5 MG | 5/9/2002 | |
| PENTA-MEDROXYPROGESTERONE TABLETS | pentapharm ltd. | 02231769 | Tablet - Oral | 5 MG / TAB | 10/23/1998 |
| MEPROGEST | 02212072 | Tablet - Oral | 10 MG | N/A | |
| MEPROGEST | 02212056 | Tablet - Oral | 2.5 MG | N/A | |
| GEN-MEDROXY TABLET 10MG | genpharm ulc | 02229840 | Tablet - Oral | 10 MG | 3/12/1997 |
| DOM-MEDROXYPROGESTERONE | dominion pharmacal | 02247582 | Tablet - Oral | 5 MG | 5/13/2003 |
| PMS-MEDROXYPROGESTERONE | 02246627 | Tablet - Oral | 2.5 MG | 11/12/2002 | |
| RATIO-MPA | ratiopharm inc division of teva canada limited | 02148560 | Tablet - Oral | 5 MG | 7/17/1996 |
| AA-MEDROXY | aa pharma inc | 02277298 | Tablet - Oral | 10 MG | 1/10/2007 |
| GEN-MEDROXY TABLET 5MG | genpharm ulc | 02229839 | Tablet - Oral | 5 MG | 3/12/1997 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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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