Lower-Dose DMPA
Depo-Provera 45 mg, Depo-Provera 75 mg
- User: Female
- Hormonal: Hormonal
-
Delivery type:
- Injectable
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Intended Duration:
- Short-Acting
- Development Stage: Phase I
- Developer(s)/researcher(s): FHI 360
Details
- API: Medroxyprogesterone Acetate
- Target: Progesterone Receptor
-
Mechanism of Action:
- Ovulation Inhibition
- Cervical Mucus Changes
- Endometrial Changes
- Regimen: 1 Injection/3 Months
- MPT: Not Potential MPT
- Promising Attributes: A lower-dose subcutaneous injectable may lower MPA exposure and potentially minimize undesirable side effects associated with currently-approved DMPA injectables.
Product Status
Results of 2021 publication indicate that a dose below 105 mg is likely not viable.
History
2004: Dose finding study conducted by the manufacturer indicate suppression of ovulation for three months in patients given subcutaneous 50mg injections of Depo Provera CI, a existing product currently dosed IM at 150mg.
2017: FHI 360 initiates PK/PD study intended to determine the lowest dose of Depo Provera CI, a product indicated for intramuscular injection, that would reliably suppress ovulation for four months (three months of use followed by a 1-month grace period for re-injection) if injected subcutaneously.
2021: PK/PD study results are published, confirming 105mg to be the lowest dose of Depo Provera CI to reliably suppress ovulation over four months.