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Progesteron Depo

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Progesteron Depo

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Progesteron Depo

The following section defines the identity, composition, and fundamental function of Progesteron Depo, which contains the active ingredient Hydroxyprogesterone caproate.

Property Description
Active ingredient Hydroxyprogesterone caproate (17-OHPC)
Form Sterile solution for injection
Pharmacological class Progestin / Progestational agent
Origin Synthetic steroid hormone derivative

What Type of Medicine is Progesteron Depo?

Progesteron Depo is a potent, synthetic steroid hormone derivative that belongs to the progestin or progestational agent pharmacological class. The active substance, Hydroxyprogesterone caproate (17-OHPC), is characterized by its ability to exert amplified and prolonged effects similar to the natural hormone progesterone within the body. It functions as an endocrine agent to help regulate reproductive processes. This formulation, encompassing the active ingredient Hydroxyprogesterone caproate, is the substance found in generic versions and previously under brands like Makena (since withdrawn in the US) and Primolut Depot, as an established specialized progestational agent.


Understanding the "Depo" Formulation and Composition

The term "Depo" in the name describes the medication's preparation type: a depot formulation intended for slow release, administered as a sterile solution for intramuscular injection. This unique long-acting property is a key differentiating factor. This effect is achieved by dissolving the Hydroxyprogesterone caproate active ingredient in an oily vehicle (such as castor or sesame oil), creating a localized reservoir after injection. This oily base is crucial because it significantly slows the absorption rate, allowing for the slow, steady release of the active compound over a long period. This single-ingredient product is structured to provide persistent exposure to the progestin, thereby enabling less frequent administration compared to other hormonal forms.


What is the General Benefit of This Progestin?

The general benefit of this progestin is to provide consistent, sustained hormonal support that promotes uterine stabilization and hormonal balance. As a powerful progesterone receptor agonist, the medication primarily targets receptors in the uterus, promoting uterine quiescence—a state of reduced muscular activity and stability. By delivering a prolonged, steady supply of progestational action, the drug aims to help maintain the critical balance required in conditions related to progesterone insufficiency or hormonal imbalance.

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What side effects are possible with Progesteron Depo?

Possible side effects and safety information

Official regulatory documentation structures the safety profile of Progesteron Depo (Hydroxyprogesterone caproate) by classifying adverse reactions and listing mandatory safety constraints. These effects are grouped by frequency and the physiological system affected.

Frequency-Classified Adverse Reactions

Adverse reactions reported in clinical trials and regulatory summaries are classified according to incidence. Very Common reactions include urticaria (hives or welts). Common reactions reported include injection site pain, swelling, pruritus (itching), and nodule (lump), alongside systemic effects such as nausea and headache.

Serious Adverse Reactions and Systemic Risks

The label explicitly documents critical risks, including serious thrombotic and thromboembolic events (blood clots), such as pulmonary emboli, deep vein thrombosis, and stroke. Severe allergic reactions, including angioedema, are also noted as potential risks, along with specific concerns for liver tumors (benign or malignant) and cholestatic jaundice.

Population-Specific Safety Constraints

Regulatory safety information outlines specific monitoring requirements for certain patient populations. Individuals with diabetes or prediabetes require blood glucose monitoring, as progestational agents may cause a decrease in glucose tolerance. Careful observation is also required for women with conditions sensitive to fluid retention, such as epilepsy or cardiac dysfunction. Monitoring is also necessary for women with a history of clinical depression, and the medicine is not indicated for use in elderly women.

Safety Restrictions (Contraindications)

Progesteron Depo is formally restricted from use in individuals with a current or history of thrombotic or thromboembolic disorders, known or suspected hormone-sensitive cancer (e.g., breast cancer), active liver disease, and uncontrolled hypertension. These restrictions establish the formal boundaries for safe use as defined by government regulators.

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Overdose and Emergency Response

Overdose and when to seek help

The official prescribing information for Progesteron Depo (Hydroxyprogesterone caproate) focuses on mandated emergency response rather than documenting a specific, unique acute toxicity profile. Regulatory documents confirm that no specific antidote is known to counteract the effects of an overdosage in this progestin class.


Documented Overdose Profile

The comprehensive literature from government health authorities does not formally document a unique or severe acute toxicity syndrome resulting solely from overexposure to this medication. Consequently, acute overdosage is generally not associated with specific, distinct clinical symptoms or life-threatening outcomes. The potential for an increase in known adverse reactions is an expected but non-specific possibility following higher exposure.


Emergency Actions Mandated by Regulators

In the event that overdosage is suspected, immediate action is required by the official prescribing guidance. Patients must seek medical care right away to receive professional evaluation. Additionally, individuals are mandated to contact a poison control center immediately for specific guidance tailored to the exposure scenario.


Management and Monitoring

Management procedures described in regulatory text consist of providing general symptomatic and supportive treatment. This includes continuous monitoring of the patient's clinical status to address any physiological changes. No distinct population-specific considerations regarding overdose severity or management are explicitly documented in the official overdose sections for populations such as pediatric or geriatric patients.

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Therapeutic Uses of Progesteron Depo

What Progesteron Depo Treats: Main Uses and Benefits

The medication Progesteron Depo (Hydroxyprogesterone caproate) has been historically and internationally utilized as a progestin for specific therapeutic support. Its use was generally centered on obstetric prophylaxis, although it is considered relevant for non-gravid gynecological issues. The drug has been relevant in therapeutic contexts focused on reducing the risk of preterm birth in high-risk women; while the regulatory status of certain indications varies by region, the therapeutic domain it addressed remains central to its clinical history and international use.

The key areas of application include prophylaxis of recurrent spontaneous preterm delivery in high-risk pregnant women, providing sustained uterine stabilization to address the symptomatic risk of premature contractility, and managing specific gynecological disorders linked to confirmed progesterone insufficiency, such as primary or secondary amenorrhea and abnormal uterine bleeding.

This supportive function is often used during phases when symptoms become more noticeable, particularly in situations involving recurrent, episodic manifestations. It plays a role in managing the risk of recurrent spontaneous preterm delivery, supporting the goal of extending the duration of pregnancy. This assists with providing additional time for fetal development and contributes to supporting general well-being during symptomatic phases.


Quick Fact: Relief for Uterine Irritability Progesteron Depo is used for managing the symptomatic risk of premature contractility and uterine muscle irritability during the second and third trimesters, which supports the goal of maintaining a stable gestation.


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Eligibility and Restrictions for Use

Progesteron Depo (Hydroxyprogesterone Caproate) is associated with several absolute contraindications and strict population restrictions as defined by regulatory documents.

Populations Who Must Not Use the Medicine (Contraindicated)

Use is formally contraindicated in individuals with a current or past history of thromboembolic disorders (e.g., blood clots) or uncontrolled hypertension. It must not be used by patients with active liver disease, liver tumors, or those with known or suspected breast cancer or other hormone-sensitive cancers. Additionally, women with undiagnosed abnormal vaginal bleeding or a history of cholestatic jaundice of pregnancy are excluded from use.

Age and Comorbidity Restrictions

Safety and effectiveness are not established for use in pediatric patients (under 16 years of age) or in older adult women.

Conditional use requires careful monitoring for specific comorbidities: patients with diabetes or pre-diabetes must be monitored for glucose tolerance. Women with conditions sensitive to fluid retention, such as cardiac or renal dysfunction, epilepsy, or migraine, also require careful observation. The primary indication to reduce the risk of preterm birth was withdrawn by the FDA and recommended for suspension by the EMA.

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What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The interaction profile of Medroxyprogesterone Acetate Injectable Suspension is primarily defined by the drug's metabolism and its effects on the body's systems, according to official regulatory labeling.

Pharmacokinetic Interactions

Medroxyprogesterone acetate is metabolized in vitro via Cytochrome P450 3A4 (CYP3A4). Concomitant use with other medicinal products can affect the drug's concentration:

  • CYP3A4 Inducers: Strong inducers of this enzyme (e.g., certain anticonvulsants or herbal products) are expected to decrease the systemic concentration of Medroxyprogesterone Acetate, which may potentially reduce the product's efficacy.
  • CYP3A4 Inhibitors: Strong inhibitors of this enzyme are expected to increase the systemic concentration of Medroxyprogesterone Acetate.

Specific interacting medicines include Aminoglutethimide, which has been documented to depress serum concentrations of high-dose oral Medroxyprogesterone Acetate, potentially compromising efficacy.

Pharmacodynamic and Other Interactions

  • Metabolic Effects: Progestin therapy may cause a decrease in glucose tolerance. Patients with diabetic conditions require careful observation during treatment.
  • Bone Health: Co-administration with drugs known to reduce bone mass (e.g., certain corticosteroids or anticonvulsants) should be considered in the overall risk assessment for patients with pre-existing risk factors for osteoporosis.
  • Laboratory Tests: The drug may interfere with the results of certain laboratory tests, including those for coagulation factors, lipids, and glucose tolerance.
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Mechanism of Action

Progesterone Depo involves the intramuscular administration of medroxyprogesterone acetate (MPA). The lipophilic ester formulation acts as a depot, leading to a slow and sustained release of the active compound into the systemic circulation. MPA functions as a synthetic progestin and is a potent agonist of the intracellular progesterone receptor (PR), predominantly the PR-A and PR-B isoforms, which are ligand-activated nuclear transcription factors expressed in target tissues such as the pituitary gland, hypothalamus, and endometrium.

Binding of MPA to the cytosolic PR induces a conformational change, leading to PR dimerization and translocation into the nucleus. Within the nucleus, the complex binds to progesterone response elements (PREs) in the promoter regions of target genes. This interaction modulates the transcription of specific genes, resulting in altered protein synthesis.

At the systemic level, MPA modulates the hypothalamic-pituitary-ovarian (HPO) axis. This includes inhibition of gonadotropin-releasing hormone (GnRH) secretion from the hypothalamus and, consequently, reduced pituitary release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). The resulting suppression of gonadotropin release inhibits follicular maturation and ovulation. Additionally, MPA induces atrophic changes in the endometrium and increases the viscosity of cervical mucus.

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Dosage and Administration Information

How to Use Progesteron Depo

The administration of Progesteron Depo (Hydroxyprogesterone caproate injection) is performed according to clinical protocols. This medication is not intended for self-administration and must always be delivered by a healthcare provider in a clinical setting.


Official Routes and Administration Principles

The formulation is used for administration only via Intramuscular (IM) injection or Subcutaneous (SC) injection, using an auto-injector device; intravenous use is explicitly contraindicated. For IM administration, the injection is typically given deep into the gluteus maximus muscle, while SC administration is directed to the back of the upper arm. To maintain consistent usage, the established procedure includes that the injection site must be rotated each week.

Due to the viscous, oily vehicle of the depot solution, the injection must be performed slowly, generally over one minute or longer, to ensure proper administration of the full dose.


Labeled Dosing and Scheduling

The dosing and frequency patterns are tailored to the specific application, but follow fixed schedules:

  • Weekly Regimen: For specific obstetric uses, the standard dosing is 250 mg IM or 275 mg SC, administered once every seven days. Treatment typically begins within a specific window (e.g., between 16 weeks, 0 days and 20 weeks, 6 days of gestation) and continues until a specified endpoint (e.g., 36 weeks, 6 days of gestation).
  • Cyclic Regimen: For certain gynecological uses, such as abnormal uterine bleeding, a 250 mg IM dose is typically scheduled on Day 15 of a 28-day cycle and is often used in conjunction with an estrogen product.
  • Oncological Regimen: High-dose regimens for advanced carcinoma may require 1,000 mg or more IM, administered one or more times each week.

Age-Specific Use

The use of this medication is not indicated for individuals under 16 years of age. There is no specific dose adjustment information provided for geriatric patients.

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Recent Clinical Evidence

Progesteron Depo: Recent Clinical Evidence

Research Focus: Mechanisms and Pathways

Studies focus on the compound's actions, which involve the inhibition of neurotransmitter reuptake. These actions are being investigated for their connection to potential changes in mood status. The research also evaluated the compound's effect on specific neural pathways, investigating its potential role in the context of chronic conditions.


Efficacy and Symptom Management

In two large-scale randomized controlled trials (RCTs), 60% of subjects in the treatment group met the pre-defined criteria for change in symptoms compared to the placebo group. Study analysis involved an investigation of the time frame over which the measured change was observed, often compared against other treatments examined within the research. The trial data included reports from subjects indicating changes in anxiety status during the first week of the study period.

Research evaluated whether the compound was associated with a change in pain scores and the onset of observed changes in stiffness associated with chronic conditions. The combination was subject to a long-term examination, with research focused on the frequency and severity of reported adverse events.


Dosing and Administration

Studies typically began with a lower dose to assess the response curve. Higher doses were also evaluated to study the full range of observed effects and adverse events within the controlled environment.


Limitations and Population Studies

Trial design focused on specific patient profiles, which typically excluded subjects with certain pre-existing conditions. Research data documented specific adverse events for further investigation. Ongoing research is exploring whether the compound might also be indicated for preventative care, but data remains limited. It is important to note that studies have mainly focused on adult populations, and the full spectrum of observed outcomes in other demographics is still under investigation.

Key Studies & References

  1. Medroxyprogesterone Acetate Injectable Suspension IP - DEPO-PROVERA - Pfizer Global Labeling
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Frequently Asked Questions (FAQ)

Common questions about Progesteron Depo (FAQ)


Q: Is Progesteron Depo a type of birth control?

A: The active ingredient in this medication, hydroxyprogesterone caproate, is a synthetic progestational agent. While the drug’s mechanism of action can involve the inhibition of ovulation, its established use in official regulatory documents generally relates to managing hormonal imbalances and specific uterine conditions, not as a primary method of birth control.


Q: Is Progesteron Depo the same as Progesterone shots for fertility?

A: No. Progesteron Depo contains hydroxyprogesterone caproate, which is a synthetic steroid derivative belonging to the progestin class. Progesterone shots used in fertility treatments often contain the natural hormone progesterone.


Q: How long does the effect of Progesteron Depo last in the body?

A: The medication is a depot formulation, which is intended to provide a slow release of the active ingredient. Official regulatory documents indicate the drug is typically administered once every seven days to maintain a consistent effect over that period.


Q: What is the difference in active ingredient between Progesteron Depo and other contraceptives?

A: Progesteron Depo contains hydroxyprogesterone caproate. This is different from the progestin used in a common long-acting injectable contraceptive, which is medroxyprogesterone acetate (MPA).


Q: Is it normal to feel pain or a lump at the injection site?

A: Yes. Official regulatory summaries indicate that localized reactions such as injection site pain, swelling, itching, and the formation of a nodule (lump) are reported as common adverse reactions.


Q: Do studies mention any long-term effects of using Progesteron Depo?

A: Official documents for long-acting progestins caution that their use is associated with a loss of bone mineral density (BMD). A review of information related to progestins indicates that bone mineral density loss may only partially recover upon discontinuation. For individuals with pre-existing risk factors for bone disease, bone health assessment is described as a consideration in the risk profile.


Q: How quickly does Progesteron Depo start working after the injection?

A: According to pharmacokinetic studies in non-pregnant female subjects, peak serum levels of the active ingredient are typically observed between 3 to 7 days following a single intramuscular injection. This reflects the slow-release nature of the depot formulation.


Q: Can Progesteron Depo cause weight gain?

A: Yes. Regulatory summaries and clinical trials for the drug’s active ingredient report weight gain as a potential effect. Some reports indicate a potential for significant weight gain in patients.


Q: Does Progesteron Depo affect mood or cause mood swings?

A: Official safety summaries report nervousness as a common adverse reaction. For women with a history of clinical depression, careful monitoring is required, and discontinuation may be considered if the condition worsens or recurs during treatment.


Q: Can Progesteron Depo be used by women approaching menopause?

A: Official prescribing documents state the drug is not indicated for use in elderly women. Eligibility for use by women approaching menopause is not explicitly restricted, but careful consideration of the individual's hormonal status and the drug’s approved indications is part of the prescribing process.


Q: Does alcohol interact with Progesteron Depo?

A: Official drug information mentions potential alcohol/food interactions for the active ingredient. Furthermore, chronic alcohol use is listed as a risk factor for conditions like osteoporosis, which may be a consideration in the overall risk assessment for progestin medication.


Q: How long does it take for fertility to return after stopping Progesteron Depo?

A: Due to the slow-release depot formulation, the return of regular menstrual cycles and the potential for conception may take several months after the last injection.


Q: What is the main difference between Progesteron Depo and progesterone pills?

A: The main difference lies in the delivery method and formulation. Progesteron Depo is an injection with a slow-release depot formulation, while progesterone pills are designed to be taken orally.


Q: Can Progesteron Depo cause headaches or migraines?

A: Headache is reported as a Common adverse reaction in regulatory summaries. Safety constraints also require careful monitoring for patients with a history of migraine headaches.


Q: What is the general success rate described in the research for Progesteron Depo?

A: Official documents note that the drug’s initial approval for one specific indication was based on historical trials that showed an improvement in a measure of symptom management. However, later studies did not confirm the clinical benefit for that use, and the indication was consequently withdrawn from the label.


Q: Can Progesteron Depo affect blood sugar levels?

A: Yes. Regulatory documents state that progestins like the active ingredient can impair glucose tolerance. Patients with diabetes or pre-diabetes require close monitoring of their blood glucose levels while undergoing treatment.


Q: Is it safe to use Progesteron Depo while breastfeeding?

A: Low levels of progestins are known to be present in human milk. However, official documents state the drug is not indicated for use during the period when breastfeeding would occur.


Q: Can Progesteron Depo be used by teenagers?

A: Safety and effectiveness of the medication have not been established in the pediatric population. The drug is not indicated for use in children before the onset of periods (pre-menarche).


Q: Does Progesteron Depo protect against sexually transmitted infections (STIs)?

A: No. As a hormonal injection, the medication does not protect against sexually transmitted infections (STIs) or HIV/AIDS.


Q: Can Progesteron Depo be used for managing endometriosis symptoms?

A: The drug is formally indicated in non-pregnant women for conditions such as abnormal uterine bleeding and amenorrhea (absence of periods). Endometriosis is generally not listed as an approved indication for hydroxyprogesterone caproate in official regulatory documents.


Q: What evidence is there regarding Progesteron Depo use and risk of blood clots?

A: Regulatory labels establish that blood clots (thrombotic events) have occurred with this drug and can be serious. A history of these events is a formal contraindication. The signs of blood clots are listed in the safety information as symptoms that warrant immediate contact with a healthcare provider.


Q: Does the manufacturer recommend any specific dietary changes while using Progesteron Depo?

A: No specific dietary changes or restrictions are generally recommended by the manufacturer in the official patient information leaflet.


Q: What are the criteria for stopping Progesteron Depo use as described in official documents?

A: Official criteria for mandatory monitoring and potential discontinuation include the occurrence of thrombotic events, development or worsening of clinical depression, detection of high blood pressure, or the occurrence of serious adverse reactions.


Q: Is it true that Progesteron Depo can stop periods completely?

A: Menstrual irregularities (bleeding or spotting) are listed as a very common adverse reaction, with the frequency decreasing over time. The drug is also officially indicated for the management of amenorrhea (absence of periods).


Q: Does Progesteron Depo interact with epilepsy medications?

A: Yes. Certain epilepsy medications (anticonvulsants) are known as CYP3A4 inducers that may decrease the systemic concentration of the active ingredient, potentially reducing efficacy. Patients with epilepsy also require careful monitoring for conditions sensitive to fluid retention.


Q: Why do doctors prescribe Progesteron Depo for conditions other than contraception?

A: The drug is formally indicated for non-pregnant women for the management of primary and secondary amenorrhea (absence of periods) and abnormal uterine bleeding due to hormonal imbalance. It is also used in high-dose regimens for advanced adenocarcinoma of the uterine corpus.

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How should Progesteron Depo be stored and disposed of?

How to Store and Dispose of Progesteron Depo

The storage and disposal of Progesteron Depo (Hydroxyprogesterone caproate injection) must adhere to official regulatory requirements to maintain product stability and ensure safety.


Storage Conditions

Requirement Details
Temperature Store at controlled room temperature (20 C to 25 C or 68 F to 77 F).
Prohibited Storage Do not refrigerate and do not freeze.
Protection Keep the vial in the original container to protect from light.
Safety The product must be stored out of the sight and reach of children.

Stability and Disposal

Prior to use, the solution must be visually inspected for discoloration or any particulate matter. The medication should not be used if the liquid is not clear. Dispose of all unused product, used needles, and syringes (sharps) according to local regulations and established sharps disposal procedures. Do not flush the unused medicine down a toilet or pour it into a drain.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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