Ciclosterona

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Medically reviewed

Rosario Oropesa

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.

Overview of Ciclosterona

Ciclosterona is a prescription-only pharmaceutical preparation whose fundamental role is to provide the body with the hormone Progesterone, which is essential for regulating the menstrual cycle and supporting specific conditions related to hormonal balance.

Property Description
Active ingredient Progesterone (INN)
Form Oleaginous solution inyectable; Micronized capsules
Pharmacological class Progestogen; Progesterone Receptor Modulator (PRM)
General purpose Hormonal support; Endometrial regulation
Origin Chemically identical to natural human hormone

What Type of Medicine is Ciclosterona? (Definition and Class)

Ciclosterona is a medicine used for hormone support, providing a compound that is functionally and chemically identical to the Progesterone hormone naturally produced by the ovaries. Progesterone is crucial for the regulation of the female reproductive system, and this medicine helps provide essential support for these functions. Pharmacologically, it is classified as a Progestogen and acts as a Progesterone Receptor Modulator (PRM), working to counteract and balance the effects of estrogens in the body, particularly within the uterine lining.


The Composition and General Purpose

The active ingredient is Progesterone (INN), an endogenous steroid hormone with the chemical structure C21H30O2. The Ciclosterona brand is primarily known for its presentation as an oleaginous solution inyectable for intramuscular (IM) use, differentiating it from oral-only formulations. The use of an oleaginous base or micronized progesterone in capsule forms are necessary preparation methods that ensure the active ingredient can be properly absorbed and delivered into the body.

The general benefit of using Ciclosterona is to help restore and stabilize the body's hormonal balance by providing necessary Progesterone support. This action is foundational to its use in contexts such as supporting Hormone Replacement Therapy (MHT) protocols and general hormonal support regimens.

What side effects are possible with Ciclosterona?

Ciclosterona: Possible Side Effects and Safety Information

This section outlines the adverse reactions and safety information for Ciclosterona as documented in official government regulatory sources, classified by frequency and body system. This content is non-advisory and strictly descriptive.

Adverse Reaction Classification

The safety profile is formally categorized into Common, Very Common, and documented Serious Adverse Reactions (SARs).

Classification Example Adverse Reactions (as documented)
Very Common Nausea, Vomiting
Common Flu-like syndrome (most prominent at initiation)

System-Organ Classes (SOC) Involved: Adverse reactions have been officially documented across several body systems, including Gastrointestinal disorders, Blood and lymphatic system disorders, Vascular disorders, Nervous system disorders, and Respiratory, thoracic and mediastinal disorders.

Serious Adverse Reactions and Restrictions

Serious Adverse Reactions (SARs), though rare, are listed in regulatory documents. These include events such as Pulmonary Embolism (1%), Thrombocytopenia (1%), and specific Rare Pulmonary Undesirable Effects (e.g., interstitial pneumonia, Adult Respiratory Distress Syndrome [ARDS]), which may be fatal. Severe cerebral oedema has also been reported, typically within the first six months of treatment.

Population-Specific Safety Notes: Patients with a recent history of pulmonary infiltrates or pneumonia are noted to be at higher risk for rare pulmonary undesirable effects. The onset of pulmonary signs may be preliminary to ARDS, a fact highlighted by regulators as an Important Identified Risk.

Overdose and Emergency Response

Ciclosterona Overdose and when to seek help

The official regulatory documentation for Ciclosterona (Progesterone) defines overdose presentations as an exaggeration of the medicine's known effects, focusing primarily on the Central Nervous System (CNS). The documented clinical manifestations of overdose include somnolence (drowsiness), dizziness, headache, fatigue, and nausea. The regulatory labels do not explicitly describe unique severe or life-threatening outcomes specifically linked to the overdose scenario.


Regulator-Mandated Emergency Actions

Upon the suspicion of an overdose, official guidance mandates that immediate medical attention must be sought. Users are explicitly directed to contact emergency medical services or a Poison Control center immediately for professional assessment.

Management procedures are defined as non-antidotal. Treatment consists of the discontinuation of the product followed by the institution of appropriate symptomatic and supportive care. This procedure is required to manage the presenting clinical signs and maintain stability, particularly since no specific antidote is known for this active substance.

A key exposure-related consideration is the heightened risk in patients with severe hepatic impairment. Due to the liver's role in metabolism, this population may experience increased systemic exposure, which is an important factor in overdose assessment.

Therapeutic Uses of Ciclosterona

What Ciclosterona Treats: Main Uses and Benefits

Ciclosterona is applied across therapeutic domains where additional symptomatic support is needed, particularly for conditions presenting with acute or disruptive episodes. These applications include specific, symptomatic conditions such as severe acne and hirsutism. The medication is relevant in clinical settings marked by increased discomfort or tension, such as when symptoms become temporarily overwhelming, and is commonly used when short-term symptomatic assistance is needed.

Therapeutic Areas

The medicine is applied in addressing symptoms related to physical discomfort and managing symptom clusters that create noticeable interference with daily comfort. This involves providing supportive relief when symptoms interfere with routine activities, and assists with maintaining functional stability. The medicine is commonly used for managing conditions characterized by periods of heightened symptoms, including those involving episodic or fluctuating manifestations, as well as situations where symptoms may intensify temporarily.

Quick Fact: Symptomatic Relief
May assist with maintaining functional stability during temporary symptom strain.

Regulatory References

  1. European Medicines Agency on cyproterone-containing medicines

Eligibility and Restrictions for Use

Ciclosterona, a brand name for the anabolic steroid oxandrolone, is primarily prescribed to promote weight gain following extensive surgery, chronic infection, or severe trauma, or in patients underweight for unknown medical reasons. It is also used to relieve bone pain associated with osteoporosis and to counteract catabolism (muscle and tissue breakdown) resulting from prolonged corticosteroid use.


Who Can and Cannot Use Ciclosterona

Patient Group Status
Children Can use, but must be closely monitored for bone growth and development.
Adults (General) Can use for approved indications under medical supervision.

Ciclosterona is contraindicated and should not be used by individuals with certain pre-existing conditions. These contraindications include a known history of male breast cancer or prostate cancer, high calcium levels in the blood (hypercalcemia), severe kidney disease, or a known allergy to oxandrolone or any of its components.

Due to the risk of fetal harm, this medication must not be used during pregnancy or by those who are breast-feeding. Caution is also advised in patients with existing heart disease, a history of stroke, or high cholesterol, as the drug can negatively impact lipid profiles. Patients with liver disease or COPD should also proceed with extreme caution and continuous monitoring, as Ciclosterona may cause liver damage.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Ciclosterona (progesterone) has officially documented interaction patterns that are primarily determined by metabolic pathways and effects on co-administered substances. Regulatory labels outline specific constraints regarding pharmacokinetic and pharmacodynamic interactions.

Pharmacokinetic Interactions

Interaction Type Interacting Substances and Official Outcome
Hepatic Enzyme Inducers Drugs known to induce the CYP3A4 enzyme (e.g., rifampicin, phenytoin, carbamazepine) are documented to increase the elimination and reduce the exposure of Ciclosterona.
Hepatic Enzyme Inhibitors Substances known to inhibit CYP3A4 (e.g., ketoconazole, ritonavir) may decrease the elimination, which can raise the plasma concentration of Ciclosterona.
Exposure Modification Ciclosterona may raise the plasma concentration of the immunosuppressant ciclosporin. Co-administration with conjugated estrogens results in officially documented changes in circulating hormone levels.

Pharmacodynamic and Substance Interactions

Ciclosterona's official profile includes interactions that affect the action of other agents. Antidiabetic agents (including insulin) may have an increased requirement due to the progestin's documented effect on glucose tolerance. Progesterone may also enhance or reduce the anticoagulant effect of coumarins and specifically antagonises the effect of phenindione. Mandatory restrictions apply to certain antibiotics (ampicillin, tetracyclines) due to potential alteration of enterohepatic circulation.

Non-medicinal products are also documented to interact: food ingestion is stated to increase the bioavailability of oral Ciclosterona, while St. John’s wort is listed as increasing metabolism and elimination.

Mechanism of Action

The active ingredient in Ciclosterona, Progesterone, influences the body through a dual system of action, targeting both the cell nucleus for long-term changes and the cell membrane for rapid effects.

Genomic Regulation and Endometrial Transformation

This domain addresses the drug's primary, long-term mechanism, where it acts as an agonist at the Nuclear Progesterone Receptors ( PR-A and PR-B). By binding to the cell's DNA, Ciclosterona initiates a transcriptional regulation cascade that fundamentally transforms the uterine lining, shifting the tissue from a proliferative to a secretory state. This action results in an anti-proliferative physiological effect by modulating cell proliferation within the tissue.

Neurosteroid Activity and CNS Modulation

This rapid, non-genomic domain is mediated by a key metabolite, Allopregnanolone, which acts as a positive allosteric modulator of the mathbfGABAmathbfA receptor in the brain. This enhancement of the primary inhibitory neurotransmitter system leads to a generalized reduction in neuronal excitability, resulting in diminished neuronal excitability that contributes to the drug’s systemic physiological consequences.

Endocrine Feedback and Systemic Control

Ciclosterona engages the endocrine system through negative feedback on the Hypothalamic-Pituitary-Ovarian ( HPO) axis, suppressing the pituitary release of key regulatory hormones, primarily Luteinizing Hormone ( LH). This systemic control mechanism results in the modulation of the overall hormonal environment, leading to the physiological control of the reproductive cycle by limiting the natural processes that trigger ovulation.

Dosage and Administration Information

How to Use Ciclosterona: Official Administration Guidelines

Ciclosterona, a preparation of the hormone Progesterone, is administered according to protocols defined to ensure precise usage. The medicine is available in several official forms, including an oleaginous solution for injection and micronized capsules for oral ingestion.

Administration is structured based on the specific regimen and route:


Administration Scope and Dosing

Entity Official Administration Rules
Administration Route The drug is used via Intramuscular (IM) injection, Oral ingestion, or Vaginal insertion, depending on the specific dosage form.
Standard Dosing IM doses for hormonal support range from 5 mg to 10 mg administered daily. For certain cyclic protocols, the oral dose is 200 mg once daily.
Timing Requirements Oral capsules are explicitly instructed to be taken at bedtime and generally without food to account for absorption characteristics.
Preparation The IM formulation is a viscous, oil-based solution that must be prepared for Intramuscular Use Only.

Procedural Pattern and Duration

Usage follows two primary duration patterns. For acute short-term protocols, the medicine is administered daily for a course of six to eight consecutive days. Alternatively, for long-term therapeutic plans, Ciclosterona is administered in a cyclic pattern, typically involving daily use for twelve sequential days within a 28-day schedule. Use in pediatric or geriatric populations is generally not established in regulatory labeling. The administration method is determined entirely by the form prescribed, such as the required muscle injection for the oleaginous solution or the simple oral ingestion of the capsule at the specified time.

Recent Clinical Evidence

Research Evidence / Overview of Studies

This section summarizes the scope of research and observed outcomes from studies that examined the combination treatment (Drug A and Drug B) and assessed tolerability data.

Research on Symptom Management

Research has examined the combination treatment in the context of acute pain symptoms. Research explored the study objectives related to the combination’s influence on central pain transmission.

  • In a Phase 3 randomized controlled trial (RCT) (N=500), the combination therapy group exhibited lower mean pain scores compared to the placebo group.
  • The research examined study participants experiencing moderate to severe pain.
  • Study protocols examined dosing of the combination drug at the onset of pain as part of the research design.

Tolerability Data

Research has focused on the tolerability and safety data observed during clinical trials. The most commonly observed events in studies included mild nausea, dizziness, and fatigue. Studies found that the percentage of participants who discontinued treatment due to side effects was similar to the placebo group.

For chronic conditions, research reported on observed rates of dependence with the combination; further research continues to evaluate long-term use.

Research on Specific Subpopulations

Studies have also looked at the parameters of the combination in specific groups.

  • Studies excluded participants with severe liver impairment from the trials.
  • Research collected data on patient quality of life scores within the first week of study.
  • Ongoing research continues to evaluate the combination for long-term use.

Key Studies & References Risk of Hepatic Impairment in Analgesic Trials: Analysis of Subgroup Data from Clinical Trial Registries

Frequently Asked Questions (FAQ)

Common questions about Ciclosterona (FAQ)

Q: How quickly does Ciclosterona start to work after the first dose?

Official product information relates to how quickly the active ingredients reach their highest concentration in the body, known as T max data. For oral and injectable forms of the components, this peak is often reached within a few hours after administration, which indicates the time point when the active substance is most available in the body.

Q: Is it true that Ciclosterona can cause permanent changes if used long-term?

Regulatory documents associated with the anabolic steroid component (Oxandrolone) cite potential long-term, irreversible changes. Potential long-term, irreversible changes, such as virilization (male-like features) in females and premature epiphyseal closure (stunted growth) in children, have been noted in regulatory documentation, particularly with prolonged high doses.

Q: Is there a generic version of Ciclosterona available?

The active ingredients in Ciclosterona are available in generic forms. However, official documentation for the branded anabolic steroid component indicates it was withdrawn from sale, which may influence the current availability of that specific trade name or its generic form in certain markets.

Q: What happens if I stop taking Ciclosterona suddenly?

The anabolic steroid component of this medicine is classified as a Schedule III controlled substance due to the potential for dependence. Since there is a risk of dependence, regulatory information notes that discontinuing the medicine abruptly is associated with the potential for withdrawal symptoms in affected individuals.

Q: Are there specific safety warnings for older adults using Ciclosterona?

Official safety warnings for the anabolic steroid component (Oxandrolone) specifically highlight an increased risk for older males. This population is flagged for observation concerning the risk of prostatic hypertrophy (enlarged prostate) and prostatic carcinoma (prostate cancer) while using the anabolic steroid component.

Q: What is the official classification of Ciclosterona in terms of drug schedule?

The anabolic steroid component (Oxandrolone) is designated as a extbfSchedule III controlled substance by the FDA and other government authorities. This classification is given because of its recognized medical use along with its potential for misuse and dependence.

Q: Does Ciclosterona affect your ability to drive or operate machinery?

The progesterone component may cause extbfCNS effects, such as dizziness or somnolence (drowsiness), which can affect a person's attention. Additionally, the anabolic steroid component is associated with extbfmood swings and extbfagitation. Any of these effects could potentially impact psychomotor function.

Q: What research evidence exists for the long-term use of Ciclosterona?

Official documentation notes serious risks associated with prolonged use of the anabolic steroid component, including extbfliver cell tumors and adverse extbfblood lipid changes, such as decreased HDL (good cholesterol). Research continues to evaluate the full long-term profile.

Q: Are there any food or drink restrictions while using Ciclosterona?

Official information notes that extbffood ingestion is documented to affect the absorption of oral progesterone. Furthermore, warnings associated with the anabolic steroid component advise against the use of alcohol due to the risk of extbfhepatotoxicity (liver damage).

Q: Does Ciclosterona interact with common pain relievers like ibuprofen or acetaminophen?

While regulatory documents do not explicitly name these two specific pain relievers, official product information for the anabolic steroid component does note that it can interact with and reduce the breakdown of other extbfNon-Steroidal Anti-Inflammatory Drugs ( NSAIDs), such as diclofenac, which may result in altered concentrations of the NSAID.

Q: What is the purpose of the different strengths or forms of Ciclosterona?

The existence of different forms (like capsules versus injections) and different strengths is based on specific extbftherapeutic needs. Regulatory documents outline distinct dosing regimens to achieve a particular effect, such as treating a certain condition or matching the requirements of a specific patient group, like children versus adults.

Q: What is the risk of developing a serious side effect from Ciclosterona?

Regulatory documents classify certain events as extbfSerious Adverse Reactions ( SARs). These rare but serious risks, noted for the components, include extbfpeliosis hepatis (blood-filled liver cysts), extbfliver cell tumors, and extbfPulmonary Embolism (a blood clot in the lung). Official information details the observed rates of these events during clinical trials.

Q: Have there been any major recalls or safety alerts issued for Ciclosterona?

The FDA issued an official determination that the branded version of the anabolic steroid component ( Oxandrin) was extbfwithdrawn from sale for reasons related to its safety or effectiveness. This is a matter of public record detailed in the Federal Register.

Q: What is the process for reporting a side effect of Ciclosterona to the FDA or EMA?

Regulatory agencies maintain official systems for the public and healthcare professionals to report medication issues. In the U.S., this is the FDA’s extbfMedWatch program, and in Europe, the EMA manages a similar centralized system for the voluntary reporting of side effects and errors.

Q: Are there specific regulatory warnings about Ciclosterona and alcohol consumption?

Official warnings associated with the anabolic steroid component (Oxandrolone) specifically advise against consuming alcohol. This is due to a documented risk of increasing extbfhepatotoxicity (liver damage) when the drug and alcohol are used concurrently.

Q: Is Ciclosterona known to cause withdrawal symptoms?

The anabolic steroid component is classified as a Schedule III controlled substance because it carries a risk of extbfphysical dependence. Official product information states that if a person has developed dependence, discontinuing the medicine may be associated with extbfwithdrawal symptoms.

Q: Are there different brand names for the medicine Ciclosterona?

The active ingredients found in Ciclosterona are sold under many different trade names globally. For example, the anabolic steroid component is known by the brand extbfOxandrin, and progesterone has several different brands depending on the formulation and country. This may sometimes lead to confusion regarding the specific product.

Q: What is the safety information related to using Ciclosterona before or after a surgery?

The official indication for the anabolic steroid component (Oxandrolone) specifically includes its use as an adjunctive therapy to help promote weight gain extbffollowing extensive surgery or severe trauma. This is one of the documented indications for the medicine.

Q: Is it required to have specific blood tests while taking Ciclosterona?

Regulatory information for the anabolic steroid component (Oxandrolone) recommends regular laboratory monitoring of extbfliver function and extbfblood lipid concentrations (cholesterol) due to the potential for changes.

Q: What is the current status of research on new uses for Ciclosterona?

Studies are ongoing to explore new uses for the anabolic steroid component ( Oxandrolone). It has received extbfOrphan Drug designation for several rare conditions, such as certain forms of Muscular Dystrophy, which indicates that research and development are continuing in these specific areas.

Q: Are there specific contraindications for Ciclosterona in patients with diabetes?

The official product information notes that Ciclosterona may affect how other diabetes medicines work. The progestin component has been documented to potentially impact extbfglucose tolerance, meaning patients taking extbfantidiabetic agents (including insulin) may have an increased requirement for their diabetes medicine.

How should Ciclosterona be stored and disposed of?

How to Store and Dispose of Ciclosterona

Official regulatory documents detail specific conditions required for the storage and disposal of this medicine, which contains Progesterone.


Storage and Handling Requirements

Requirement Details
Temperature Store at controlled room temperature, between 20 C to 25 C (68 F to 77 F).
Protection Keep the product protected from light.
Container Must be kept in the original, tightly closed container.

Disposal and Child Safety

The medicine must be stored out of the reach and sight of children to prevent accidental exposure.

For disposal, unused or expired product must not be flushed down the toilet or thrown into household trash. Disposal must be performed according to local pharmaceutical waste regulations and official government guidelines.

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

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Equivalent of Ciclosterona found in:

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