Sop

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Sop

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.

Overview of Sop

Quick Facts

Property Description
Active ingredient Cyproterone acetate (CPA)
Form Oral tablets, Oil-based depot injection
Pharmacological class Steroidal Antiandrogen and Progestogen
Common use Mitigating conditions from androgen excess
Origin Synthetic, Pregnane steroid derivative

Defining Sop: Active Ingredient and Pharmacological Class

The medication Sop is a prescription-only, synthetic compound defined by its active ingredient, Cyproterone acetate (CPA). It is primarily classified as a dual-acting agent: a potent steroidal antiandrogen and a progestogen. Chemically, Cyproterone acetate is a Pregnane steroid derivative, meaning its structure is related to the natural hormone progesterone, positioning it within the larger class of hormone therapy agents. The World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system classifies it as an established hormonal agent.


How is Sop Formulated and Classified by Type?

Sop, containing Cyproterone acetate, is formulated for systemic effect and is available in two principal forms: oral tablets and a specialized oil-based depot injection. The oral tablets permit the oral route of administration, while the depot injection is administered via the intramuscular route for a sustained release. CPA is supplied either as a single-agent product, intended for high-dose antiandrogenic activity, or as a fixed-dose combination product that includes an estrogen, such as ethinylestradiol, which is utilized for specialized hormonal balancing protocols. Cyproterone has an established role as a treatment for androgen-dependent disorders.


The General Purpose of Antiandrogen Therapy

The general purpose of Sop is to mitigate conditions driven by an overabundance or high sensitivity to androgens in the body. The medication works through a dual mechanism: it directly blocks androgen receptors on target cells, preventing the hormones from exerting their effects, and acts as an antigonadotropin to reduce the systemic production of androgens. This comprehensive approach ensures the medication both counters the effect of circulating androgens and helps to restore hormonal balance in androgen-sensitive tissues.

What side effects are possible with Sop?

Possible Side Effects and Safety Information

The safety profile for Sop (Cyproterone acetate) is documented through regulatory classifications, organizing adverse effects by their frequency and the body system affected. Understanding these classifications is key to defining the medicine’s risk profile.


Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized by their incidence in official regulatory documents. In males, decreased libido and erectile dysfunction are classified as very common. Common effects in both sexes include depressive mood, fatigue, and weight change (gain or loss). In males, a reversible reduction of sperm count and inhibition of spermatogenesis are also common. Uncommon reactions may include rash, while rare documented reactions include hypersensitivity reactions and benign hepatic tumours.


Serious Adverse Reactions and Safety Constraints

Regulatory labels specify certain serious risks. These include the potential for hepatic failure (sometimes fatal) and the risk of thromboembolic events, such as deep vein thrombosis. Furthermore, use is associated with a documented risk of developing meningioma primarily with long-term, high-dose exposure. For specific populations, the medicine is contraindicated in individuals with a current or history of meningioma, existing severe hepatic disease (excluding metastases from prostatic carcinoma), or certain thromboembolic conditions. Diabetics require careful monitoring of glucose control while using Sop.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents for Cyproterone acetate (Sop) provide specific guidance on documented overdose situations, outlining the known risk profile and required emergency actions. The information is derived from government-authorized prescribing summaries.

Feature Official Regulatory Statement
Documented Overdose Manifestations No reports of serious illness have been documented following the acute, single-dose ingestion of Cyproterone acetate.
Antidote Information No specific antidote is known for this medication.
Required Management Treatment, if deemed necessary based on the clinical presentation, should be symptomatic.

Emergency Action

When an overdose of Sop is suspected, the regulatory guidance mandates that a patient or caregiver contact a doctor or healthcare professional for instruction on what action to take. Urgent medical attention is required when seeking advice from the healthcare professional as soon as possible following the ingestion of the medication. No continuous hospital monitoring requirements are explicitly detailed for acute overdose, nor are population-specific overdose risks noted in the official prescribing information.

Overdose Profile Summary

The regulatory profile for Sop defines acute overdose primarily by the reported absence of severe acute effects from a single event. This low documented risk dictates the mandated emergency action, which focuses on seeking timely professional medical guidance. All treatment is constrained to supportive care for any non-serious symptoms that may occur, reinforcing the lack of a known specific antidote.

Therapeutic Uses of Sop

What Sop Treats: Main Uses and Benefits

Sop (Cyproterone acetate) is commonly used across several domains to provide symptomatic support and address medical conditions driven by a heightened physiological activity or high sensitivity to androgens.

In women, the medication is applied in situations involving certain distressing symptoms of hyperandrogenism. This includes helping to manage moderate-to-severe acne, excessive hair growth (hirsutism), seborrhea, and menstrual cycle irregularity tied to these disorders. The primary benefit contributes to easing the overall symptom load and supports patients during episodes of heightened discomfort.

In male patients, Sop is relevant for easing discomfort related to disease progression in advanced or metastatic prostatic carcinoma and is also used to help moderate pathological hypersexuality. This palliative use provides support that helps ease the overall symptom burden.

“May assist with symptomatic relief in situations where androgen-related effects are difficult to tolerate or persistent.”


Quick Fact: Relief for Androgen-Driven Symptoms
Symptom Areas Skin, hair, endocrine function, and prostate-related discomfort
Use Context Chronic symptomatic management or palliative care
Primary Benefit Supports general well-being during symptomatic phases and assists with maintaining functional stability

Eligibility and Restrictions for Use

Eligibility Scope

Sop (Cyproterone acetate) is a prescription medicine with strictly defined regulatory eligibility criteria. Use is established in adult males (for advanced prostate carcinoma and sexual deviations) and adult females (for severe androgen-dependent conditions). Older adult males may use the medicine for prostate carcinoma without mandated dose adjustments based on age alone [Source 2.1].

Classification Population or Condition Status
Absolutely Contraindicated History of Meningioma (all dose forms) [Source 2.2]; Severe Liver Disease (e.g., Dubin-Johnson, Rotor syndromes) [Source 2.2]; Existing Thromboembolic Processes (blood clots) [Source 2.2]; Pregnancy and Lactation [Source 3.7]; Hypersensitivity to the active substance [Source 2.2].
Not Recommended Children and Adolescents (below 18 years of age) due to the potential to affect puberty and growth [Source 2.2].
Restricted/Conditional Use Women of Childbearing Potential must exclude pregnancy and use effective contraception during treatment [Source 1.4]. For non-prostatic indications (e.g., hirsutism, acne), the medicine is restricted to use only after other treatment options have failed [Source 2.1, 2.2].

Eligibility-Context Constraints

The regulatory profile is defined by organ function status (prohibiting use in severe liver impairment), oncological history (contraindicating prior meningioma), and reproductive status (prohibiting use during pregnancy). Use in severe renal impairment is documented as not specifically investigated [Source 2.1].

What should I know about interactions with other medicines?

The official regulatory profile for Sop (Cyproterone acetate) is characterized by its interaction with the Cytochrome P450 (CYP) enzyme system. Sop is primarily cleared by CYP3A4 and is officially documented to inhibit this and other CYP enzymes, which defines its interaction potential with numerous medicines.

Drug and Substance Interactions

Co-administration with strong CYP3A4 inhibitors (such as certain antifungal or anti-HIV agents) is expected to increase the plasma concentration of Sop by reducing its clearance. Conversely, strong CYP3A4 inducers (such as rifampicin or the herbal product St. John's Wort) are expected to decrease Sop levels, potentially leading to a loss of official effect.

A Pharmacodynamic Interaction exists with HMG-CoA Reductase Inhibitors (statins). Co-use with high doses of Sop may increase the documented risk of myopathy or rhabdomyolysis due to shared metabolic pathways. When Sop is administered as a fixed-dose combination product, co-administration with other hormonal contraceptives is classified as contraindicated.

Timing and Population Considerations

Regarding substance interactions, alcohol consumption may officially reduce the antiandrogenic effect of the medicine. The administration rule for oral tablets states they must be taken after meals. Finally, caution is warranted for diabetic patients due to the possibility of the medicine causing a loss of blood glucose control, and certain severe hepatic dysfunctions are contraindications due to impaired Sop clearance.

Mechanism of Action

Receptor-Mediated Signaling Modulation

This domain covers the drug's primary action, which involves modulating specific receptor- or enzyme-mediated signaling pathways. Sop functions as a selective modulator to either initiate or suppress signaling sequences, thereby modifying early molecular steps within the pathway.


Key Pathway Modulation and Homeostatic Effects

The drug modulates key pathways and affects systems where specific transmitters or mediators dominate. This engagement influences the feedback regulation within pathways, resulting in modified pathway output.


Engagement with Target Regulatory Mechanisms

Sop engages mechanisms that influence key regulatory processes. The alteration of pathway activity results in a reduction of mediator activity and shifts the system's output toward a new steady state.

Dosage and Administration Information

How Cyproterone acetate (Sop) is Used

Administration of Cyproterone acetate (Sop) follows distinct regimens based on the formulation and authorized use. The two approved routes of administration are oral for tablets and intramuscular for the oil-based depot injection.


Official Dosing and Scheduling

Usage Context Dosing Regimen (Adults) Frequency and Timing Special Conditions
Advanced Prostatic Carcinoma Oral doses of 200 mg to 300 mg daily Dose must be divided into 2 or 3 daily intakes Used as a long-term palliative regimen
Hormonal Balancing (Combination Tablet) 2 mg CPA / 35 micrograms Ethinylestradiol Taken daily for 21 days, followed by a 7-day break Cyclic use; continued for 3 to 4 cycles after symptom resolution

General Administration Protocol

Oral tablets are required to be taken after meals with some liquid. This instruction provides clear guidance on the proper daily intake context. If an oral dose is missed, the dose is typically skipped if it is almost time for the next scheduled dose, and a double dose must not be taken to compensate for the missed one. The medication is not recommended for use in male patients under 18 years of age or before the conclusion of puberty. The fixed-dose combination tablet is used in a structured 21/7 day cycle that establishes the duration and rhythm of the administration plan. For monotherapy in women, an additional, non-hormonal contraceptive method is required during the cyclic use period.

Recent Clinical Evidence

Research evidence / Overview of studies for Sop

Research Evidence for Androgen-Related Conditions in Women

Research has studied Cyproterone acetate (Sop) in populations with severe hirsutism (excessive hair growth) and moderate-to-severe acne and seborrhea (oily skin), in populations where symptoms are related to androgen effects. This work includes Randomized Controlled Trials (RCTs) and Systematic Reviews primarily in women of reproductive age. These studies measured objective endpoints related to skin and hair symptoms, such as changes in hair growth scores and skin lesion counts, and changes in certain endocrine biomarkers. The findings described are predominantly associated with the medication's use in a fixed-dose combination with an estrogen, as opposed to the single-agent form of Sop. What remains uncertain is the durability of these reported changes, as long-term effects are not fully established.


Evidence for Advanced Prostate Carcinoma

Sop was evaluated in adult males with advanced or metastatic prostatic carcinoma. The research in this area includes large-scale Randomized Controlled Trials (RCTs) designed to monitor outcomes reflecting daily functioning or activity level, such as overall survival time and time until disease progression. Sop was studied for use as part of combined hormonal regimens, and also was studied to address a short-term risk known as "tumor flare" that may occur when initiating certain other types of hormonal treatment. However, when examining its role within broader antiandrogen treatment, findings were mixed regarding differences in overall survival time when compared to alternative hormonal therapies. Long-term effects are not fully established regarding a consistent survival pattern over all other hormonal options.


Research on Hypersexuality and Sexual Drive Control

Research for the use of Sop in pathological hypersexuality is characterized by a different research structure. This research was observed in adult males in specialized clinical or forensic settings, focusing on patient-reported outcomes describing perceived changes in sexual urges and shifts in sexual thoughts and behavior. The available research consists primarily of Case Reports and Small Open-Label Trials. Certainty remains low for this indication, as there is a notable absence of large, modern, placebo-controlled trials. The available evidence primarily provides insight into group patterns, not personal outcomes.

Frequently Asked Questions (FAQ)

Common questions about Sop (FAQ)


Q: How long does it usually take before I can expect Sop to start working?

Studies and official information indicate that, while the active substance reaches its peak level in the blood relatively quickly (within hours), the time required for a patient to experience noticeable clinical effects is generally longer. For conditions like severe skin symptoms, the time frame for initial improvement observed in studies is typically measured in months rather than weeks.


Q: Does Sop stay in your system for a long time?

Yes, official regulatory documents concerning the drug’s processing by the body (pharmacokinetics) indicate that the active ingredient has a relatively long elimination half-life, which is approximately 38 hours. This documentation suggests it takes several days for the substance to be largely cleared from the body after the last dose.


Q: Will Sop still work if I occasionally drink alcohol?

Official information indicates that alcohol consumption may reduce the intended antiandrogenic effect of the medicine. This is a primary concern noted in regulatory texts, particularly regarding the treatment of male hypersexuality, but the potential interaction is a point of consideration noted in regulatory texts.


Q: Is Sop safe to use while breastfeeding or pregnant?

According to the official product information, the use of this medicine is absolutely contraindicated during pregnancy and while breastfeeding. This safety constraint is in place due to the hormonal nature of the drug and the potential for harm to the developing fetus or infant.


Q: Can Sop affect my mood or mental state?

Official regulatory documents list a depressed mood and fatigue as common documented side effects in both male and female patients. Regulatory patient information suggests that any concerning mood changes or depressive symptoms, especially shortly after beginning treatment, should be discussed with a healthcare professional.


Q: Can Sop affect blood sugar levels?

Official warnings note that this medicine can influence carbohydrate metabolism, which is relevant to blood sugar control. Due to this concern, regulatory documents indicate that patients who have diabetes need careful medical supervision and regular monitoring of their blood glucose parameters.


Q: What should I do if I think Sop is causing a bad interaction with another drug?

While regulatory documents detail the known drug interactions, official patient information recommends contacting a healthcare professional or pharmacist if a suspected adverse reaction or interaction occurs. These professionals can provide guidance consistent with your care plan.


Q: If I miss a dose of Sop, will that ruin the treatment?

No information suggests that a single missed dose ruins the entire treatment course. Regulatory instructions for a missed oral dose detail that the dose is typically skipped if the time for the next scheduled dose is near, and they specifically state that a double dose should not be taken to compensate.


Q: Are there any specific foods I should avoid while on Sop?

Official documentation does not mandate the avoidance of specific food types while using this medicine. However, the regulatory requirement for the oral tablet is that it must be taken after meals for proper administration.


Q: Is there a generic version of Sop available?

The active ingredient in Sop is Cyproterone acetate, which is known under various trade names globally, such as Androcur or Cyprostat. The availability of a direct generic equivalent for this medicine is dependent on the specific country's regulatory approvals and patent status for the active ingredient.


Q: Do I need to take Sop at a specific time of day?

The official administration instructions describe that the oral tablet is taken after meals; this is the key timing constraint noted in the product label. Regulatory documents do not specify a strict time of day (such as morning versus evening) for taking the medicine.


Q: Can Sop cause problems with sexual function?

Yes, regulatory information documents that problems with sexual function are common. Specifically, decreased libido (sex drive) and erectile dysfunction are classified as very common adverse effects in males. Decreased libido is also documented as an uncommon effect in females.


Q: How should Sop be stored?

The label specifies that the medicine must be stored strictly according to regulatory standards, which generally involve keeping it at room temperature and protecting it from light, heat, and moisture. All formulations must be kept in the original container and stored out of the sight and reach of children.


Q: If Sop is not working, how long should I wait before talking to my doctor?

Regulatory guidance, especially for hormonal balancing uses, notes that the need to continue treatment should be evaluated periodically by the treating physician. Studies indicate that the time required to assess if the medicine is providing relief for symptoms is typically a period of three months or more, establishing this as the usual time frame before a formal assessment of efficacy.


Q: Are there any known issues with taking Sop before surgery?

Yes, because of the documented risk of thromboembolic events (blood clots), the combined hormonal product must be stopped at least four weeks before an elective major operation or any period of prolonged immobilisation. Prophylaxis may be indicated in the case of emergency surgery, according to regulatory guidance.


Q: Does Sop interact with birth control pills?

Yes, regulatory documents clearly state that when Sop is used as a fixed-dose combination product, co-administration with other hormonal contraceptives is contraindicated. Furthermore, certain substances that interact with Sop's clearance can also reduce the effectiveness of other hormonal contraception methods.

How should Sop be stored and disposed of?

The medicine must be stored strictly according to the official regulatory label to ensure stability.

Storage Requirements

Sop (Cyproterone acetate) is required to be stored at room temperature, typically below 25 C to 30 C, and must be protected from light, heat, and moisture.

It must be kept in its original container and carton, and specific liquid formulations must not be frozen. Due to its hormonal activity, all formulations must be kept out of the sight and reach of children.

Disposal Instructions

Unused or expired medicine must not be discarded into wastewater or household trash, as mandated by regulatory documents to prevent environmental contamination.

Disposal must follow local and national regulations for pharmaceutical waste, usually requiring the product to be returned to a pharmacy or an approved collection point.

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

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