DEPO-SUBQ PROVERA 104 (medroxyprogesterone acetate) · Pfizer
Depo-SubQ Provera 104 is a progestin-based injectable suspension indicated for the prevention of pregnancy in females of reproductive potential and for the management of pain associated with endometriosis. Use is generally limited to two years due to the risk of significant bone mineral density (BMD) loss, which may not be completely reversible. It should only be used long-
How DEPO-SUBQ PROVERA 104 Works
This medication works by inhibiting the secretion of gonadotropins, which primarily prevents the maturation of follicles and stops ovulation. It also causes the cervical mucus to thicken, creating multiple actions that contribute to its contraceptive effect.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-12-17
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
DEPO-SUBQ PROVERA 104 Approval History
What DEPO-SUBQ PROVERA 104 Treats
1 indicationsDEPO-SUBQ PROVERA 104 is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
DEPO-SUBQ PROVERA 104 Boxed Warning
LOSS OF BONE MINERAL DENSITY Women who use medroxyprogesterone acetate injectable suspension 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 medroxyprogesterone acetate injectable suspension 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 l...
WARNING: LOSS OF BONE MINERAL DENSITY Women who use medroxyprogesterone acetate injectable suspension 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 medroxyprogesterone acetate injectable suspension 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)] . Medroxyprogesterone acetate injectable suspension 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 medroxyprogesterone acetate injectable suspension 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 medroxyprogesterone acetate injectable suspension 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) Medroxyprogesterone acetate injectable suspension 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)
DEPO-SUBQ PROVERA 104 Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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-SUBQ PROVERA 104 FDA Label Details
Indications & Usage
FDA Label (PDF)Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate injectable suspension 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 Warnings and Precautions ]. Medroxyprogesterone acetate is a progestin indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate injectable suspen...
WARNING: LOSS OF BONE MINERAL DENSITY Women who use medroxyprogesterone acetate injectable suspension 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 me...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment