PROVERA (medroxyprogesterone acetate)
PROVERA is indicated for the treatment of Secondary Amenorrhea; Abnormal Uterine Bleeding; Endometrial Hyperplasia.
Details
- Status
- Prescription
- First Approved
- 1959-06-18
- Routes
- ORAL
- Dosage Forms
- TABLET
PROVERA Approval History
What PROVERA Treats
3 indicationsPROVERA is approved for 3 conditions since its original approval in 1959. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Secondary Amenorrhea
- Abnormal Uterine Bleeding
- Endometrial Hyperplasia
PROVERA Boxed Warning
CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Probable Dementia .) The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke a...
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Probable Dementia .) The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders . ) The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use .) Breast Cancer The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, Malignant Neoplasm, Breast Cancer . ) In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
PROVERA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PROVERA
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06904274 SUNFLOWER | 22923 | Ph 3 | recruiting | Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months |
| NCT05651282 RESToRE | H22-02290 | Ph 4 | completed | Risk Evaluation and Screening to Tailor Prevention and Reduce the Incidence of Endometrial Cancer |
| NCT03689543 results posted | 180144 18-M-0144 | Ph 2 | completed | Estrogen Receptor Beta and Mood |
| NCT05255653 RAINBO | RAINBO ENGOT-en14-1,2,3,4, CCTG EN.10 TAPER arm A POLE | Ph 2, Ph 3 | recruiting | Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features |
| NCT02228681 results posted | GOG-3007 CRAD001CUS236T | Ph 2 | completed | Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer |
| NCT03675139 | 53201014 | Ph 3 | completed | MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia |
| NCT02872818 | 14/128 | Ph 4 | completed | Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia |
| NCT02340013 | 2014-01 | Ph 4 | completed | Endometrial Shedding Prior to Ovulation Induction Pilot Study |
| NCT01148420 results posted | 13530-01 | Ph 4 | completed | DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROVERA FDA Label Details
Indications & Usage
FDA Label (PDF)PROVERA is indicated for the treatment of Secondary Amenorrhea; Abnormal Uterine Bleeding; Endometrial Hyperplasia.
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, C...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.