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MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone acetate inhibits gonadotropin secretion, preventing follicular maturation and ovulation, and thickens cervical mucus for contraception.
At a glance
| Generic name | MEDROXYPROGESTERONE ACETATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1959 |
Mechanism of action
Medroxyprogesterone acetate works by inhibiting the secretion of gonadotropins. This inhibition prevents the maturation of follicles and ovulation, and it also causes the cervical mucus to thicken. These effects collectively contribute to its contraceptive properties.
Approved indications
Boxed warnings
- 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)
Common side effects
- Menstrual irregularities - bleeding
- Amenorrhea
- Weight gain >10 lb at 24 months
- Headache
- Abdominal pain/discomfort
- Nervousness
- Asthenia/fatigue
- Leg cramps
- Nausea
- Leukorrhea
- Breast pain
- Bloating
Serious adverse events
- Loss of Bone Mineral Density
- Thromboembolic disease
- Breast Cancer
- Anaphylaxis and Anaphylactoid Reactions
- Osteoporosis including osteoporotic fractures
- Angioedema
- Allergic reactions
- Chest pain
- Depression
- Dysmenorrhea
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)
- 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)
- Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone (PHASE4)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |