Proluton Depot
✅ Supports pregnancy development
✅ Reduces miscarriage risk
✅ Boosts progesterone levels
✅ Enhances pregnancy likelihood
Proluton Depot contains Hydroxyprogesterone
✓ Medically reviewed by Morgan Ellis — Pharmacy Researcher · 8 years experience · Last reviewed: May 2026
💡 Quick Answer
Proluton Depot is 17-alpha hydroxyprogesterone caproate (17-OHPC) 250 mg in oil for intramuscular injection. Historically used for preterm birth prevention in singleton pregnancies with prior preterm birth, threatened miscarriage, and luteal support. Critical regulatory note: the FDA withdrew Makena (17-OHPC) approval in 2023 after the PROLONG confirmatory trial failed to show preterm-birth-prevention benefit. Clinical use has declined accordingly in US practice. This product is not for menopausal HRT.
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What Is Proluton Depot?
Proluton Depot is a branded generic of 17-alpha hydroxyprogesterone caproate (17-OHPC) 250 mg, a synthetic long-acting progestin administered as an intramuscular injection in oil. It is distinct from natural progesterone — 17-OHPC is a more lipophilic progestogen with a much longer duration of action. Manufactured by Bayer.
Important Regulatory Context (2023 FDA Withdrawal)
The original FDA approval of 17-OHPC (Makena) for preterm birth prevention was based on the 2003 Meis trial, which showed reduced preterm birth in women with prior preterm birth. The PROLONG confirmatory trial (2019) did not replicate benefit. In March 2023, the FDA formally withdrew approval of Makena (17-OHPC) for preterm birth prevention.
Clinical practice has accordingly declined. Some centres still use 17-OHPC off-label or in specific high-risk subgroups; others have discontinued entirely. Any decision to use 17-OHPC should involve a specialist obstetrician reviewing current evidence for your individual case.
Historical and Current Uses
- Prior preterm-birth prevention (FDA-withdrawn 2023): 250 mg IM weekly from week 16–20 through week 37 in women with singleton pregnancy and prior spontaneous preterm birth. Efficacy not confirmed by PROLONG trial.
- Threatened miscarriage (selected high-risk cases with prior loss): non-FDA-approved indication. Evidence is limited and mixed.
- Luteal phase support in fertility treatment (less common than natural progesterone).
- Secondary amenorrhoea and functional uterine bleeding (historical use; oral progestins now preferred).
How to Use Proluton Depot
- Administered by a clinician or trained patient as a deep intramuscular injection in the upper outer quadrant of the buttock (gluteus), using a 21 gauge needle.
- Standard dose: 250 mg (1 mL) weekly for preterm-birth prevention historic protocol.
- Rotate injection sites to reduce soreness and nodule formation.
- Timing and duration should be directed by a specialist obstetrician based on current individualised risk-benefit.
Side Effects
Injection-site: pain, swelling, pruritus, bruising, nodule.
Systemic: urticaria, nausea, diarrhoea, mood changes, fluid retention.
Serious: VTE (DVT, PE), allergic reactions, depression, gestational diabetes (possibly).
Who Should Not Use Proluton Depot
- Current or history of thromboembolic disease
- Active liver disease or liver tumours
- Known or suspected breast or genital malignancy
- Uncontrolled hypertension
- Castor oil or castor-oil-derivative allergy
- Multiple gestation (no benefit shown; potentially harmful)
Storage
Store at room temperature (15–25 °C / 59–77 °F). Do not refrigerate. Protect from light. Keep out of reach of children.
Frequently Asked Questions
Is Proluton Depot still recommended for preterm birth prevention?
Following the PROLONG trial and 2023 FDA withdrawal of Makena, routine use of 17-OHPC for preterm birth prevention is no longer standard in the US. Some specialists may still use it in specific high-risk subgroups. Discuss with an experienced maternal-fetal medicine specialist.
Is Proluton Depot the same as micronized progesterone?
No. 17-OHPC is a synthetic long-acting progestin with a longer half-life and different pharmacology. Vaginal micronized progesterone is now often preferred over 17-OHPC for luteal support and preterm birth prevention in women with short cervix.
Can Proluton Depot be used for menopausal HRT?
It is not indicated for menopausal HRT. Oral micronized progesterone (endogest, susten-capsule) or dydrogesterone is standard for progestin opposition in HRT.
What are the current alternatives for preterm birth prevention?
Vaginal progesterone (200 mg suppository daily) is considered first-line in women with short cervix detected on transvaginal ultrasound. Cerclage is an option for women with prior preterm birth plus cervical insufficiency. Individualised risk-stratification guides choice.
Is Proluton Depot safe if I am allergic to sesame or castor oil?
Check the exact vehicle in your formulation — 17-OHPC is usually in castor oil. Avoid if allergic to castor oil or its derivatives (some shampoos, lubricants, and medications).
How long do I continue Proluton Depot in pregnancy?
Historic protocol was week 16–20 through week 37 (preterm birth prevention). For luteal support in IVF, typically through early placental takeover (~week 10–12). Always follow your specialist’s individualised plan.
Can Proluton Depot cause gestational diabetes?
Some evidence suggests a modest increase in gestational diabetes with 17-OHPC use, though data are mixed. Discuss risk with your obstetrician, particularly if you have other diabetes risk factors.
Why are some women told to use vaginal progesterone instead?
Vaginal progesterone has comparable efficacy in relevant populations (short cervix) with fewer systemic side effects and no need for weekly IM injections. Professional guidelines (SMFM, ACOG) have shifted toward vaginal progesterone for selected indications since the PROLONG trial.
Related Hormone & Women’s Health Products
- Premarin (Conjugated Estrogens)
- Premarin Cream (Vaginal Estrogen)
- Progynova (Estradiol Valerate)
- Endogest (Progesterone 100 mg)
- Gestoford (Progesterone 100 mg)
- Gestheal (Progesterone 200 mg)
- Susten Capsule (Progesterone)
⚕️ Medical Disclaimer: Information is educational and does not replace medical advice. Hormone therapies carry specific risks (breast cancer, VTE, stroke, endometrial cancer if unopposed estrogen) — consult a clinician before starting, stopping, or changing any hormone medication. Individual risk–benefit depends on personal and family medical history.
Proluton Depot supplies hydroxyprogesterone for luteal-phase support after embryo transfer; the upstream ovulation-trigger step in the same fertility protocol is typically Eutrig HP 5000IU (highly purified human chorionic gonadotropin) — together they cover both halves of an IVF or IUI cycle.
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| Strength | 250 mg, 500 mg |
|---|---|
| Quantity | 1 Injection/s, 3 Injection/s, 6 Injection/s |
| Pharma Form | 1 ml in 1 ampoule |
| Manufacturer | German Remedies |
| Treatment | Preterm labor |
| Generic Brand | Progesterone |
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