Last reviewed · How we verify
Provera
At a glance
| Generic name | Provera |
|---|---|
| Sponsor | National Institute of Mental Health (NIMH) |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- 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 Warnin
Common side effects
- Menstrual irregularities (bleeding)
- Amenorrhea
- Weight gain >10 lb at 24 months
- Headache
- Abdominal pain/discomfort
- Nervousness
- Dizziness
- Libido decreased
- Asthenia/fatigue
- Leg cramps
- Nausea
- Leukorrhea
Serious adverse events
- Loss of Bone Mineral Density/Osteoporosis
- Thromboembolic disease
- Breast Cancer
- Anaphylaxis and Anaphylactoid Reactions
- Injection site abscess
- Injection site infection
- Allergic reactions including angioedema
- Chest pain
- Lipodystrophy acquired
- Injection site persistent atrophy/indentation/dimpling
Key clinical trials
- SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer
- Doxycycline and Progestin Therapy for Chronic Endometritis(CE) in Patients With Recurrent Reproductive Failure(RRF) (NA)
- Effect of Twin Hearts Meditation and Mandala Coloring on Exam Anxiety in Nursing Students (NA)
- Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification (PHASE2, PHASE3)
- Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months (PHASE3)
- A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) (PHASE2)
- Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease (PHASE4)
- Intrauterine Stent Placement Following Hysteroscopic Septum Resection (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Provera CI brief — competitive landscape report
- Provera updates RSS · CI watch RSS
- National Institute of Mental Health (NIMH) portfolio CI