DEPO-PROVERA (medroxyprogesterone acetate) · Pfizer
Depo-Provera CI is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of Depo-Provera CI is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate.
Details
- Status
- Prescription
- First Approved
- 1960-09-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DEPO-PROVERA Approval History
What DEPO-PROVERA Treats
3 indicationsDEPO-PROVERA is approved for 3 conditions since its original approval in 1960. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Secondary Amenorrhea
- Abnormal Uterine Bleeding
- Endometrial Hyperplasia
Same approved indications as PROVERA (same active ingredient).
DEPO-PROVERA Boxed Warning
LOSS OF BONE MINERAL DENSITY • Women who use Depo-Provera Contraceptive Injection (Depo-Provera CI) may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible [see Warnings and Precautions (5.1) ] . • It is unknown if use of Depo-Provera CI during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life [see Warnings and Pr...
WARNING: LOSS OF BONE MINERAL DENSITY • Women who use Depo-Provera Contraceptive Injection (Depo-Provera CI) may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible [see Warnings and Precautions (5.1) ] . • It is unknown if use of Depo-Provera CI during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life [see Warnings and Precautions (5.1) ] . • Depo-Provera CI is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Indications and Usage (1) and Warnings and Precautions (5.1) ] . WARNING: LOSS OF BONE MINERAL DENSITY See full prescribing information for complete boxed warning . • Women who use Depo-Provera Contraceptive Injection (Depo-Provera CI) may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. ( 5.1 ) • It is unknown if use of Depo-Provera CI during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. ( 5.1 ) • Depo-Provera CI is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. ( 1 , 5.1 )
Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06904274 SUNFLOWER | 22923 | Ph 3 | recruiting | Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months |
| 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.
DEPO-PROVERA FDA Label Details
Indications & Usage
FDA Label (PDF)Depo-Provera CI is indicated for use by females of reproductive potential to prevent pregnancy. Depo-Provera CI is a progestin indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of Depo-Provera CI is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. Limitations of Use : The use of Depo-Provera CI is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration and Warni...
WARNING: LOSS OF BONE MINERAL DENSITY • Women who use Depo-Provera Contraceptive Injection (Depo-Provera CI) may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible [see Warnings and Precautions (5.1) ] . • It is unknown if...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.