MEDROXYPROGESTERONE ACETATE · EUGIA PHARMA
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 ].
Details
- Status
- Prescription
- First Approved
- 1959-06-18
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET
Companies
MEDROXYPROGESTERONE ACETATE Approval History
What MEDROXYPROGESTERONE ACETATE Treats
3 indicationsMEDROXYPROGESTERONE ACETATE is approved for 3 conditions since its original approval in 1984. 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).
MEDROXYPROGESTERONE ACETATE 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)
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.
MEDROXYPROGESTERONE ACETATE FDA Label Details
Indications & Usage
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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DEPO-PROVERA
Full clinical data, patents, trials, and competitive landscape for medroxyprogesterone acetate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.