Jene

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Jene

Quick Facts

Property Description
Active Ingredients Cyproterone Acetate (CPA) and Ethinyl Estradiol (EE)
Form Oral tablet (Fixed-dose combination)
Pharmacological Class Antiandrogen combined with Estrogen
General Purpose Hormonal stabilization and androgen neutralization
Origin Synthetic, steroidal hormones

What Type of Medicine is Jene?

Jene is a prescription-only pharmaceutical product classified pharmacologically as an Antiandrogen combined with Estrogen preparation, commonly referred to by the generic name Co-cyprindiol. It belongs to the Anatomical Therapeutic Chemical (ATC) classification system code G03HB01, which designates antiandrogens and estrogens. While functioning as a type of Combined Oral Contraceptive (COC), its distinctive formulation places it in a specialized category defined by its primary therapeutic action against the physical effects of androgens. This approach is clinically recognized for providing effective hormonal management, particularly where antiandrogenic intervention is required.

The Composition: Cyproterone Acetate and Ethinyl Estradiol

The medication is an oral tablet containing a fixed-dose combination of two synthetic steroidal hormones: Cyproterone Acetate (CPA) and Ethinyl Estradiol (EE). Cyproterone Acetate acts as both a powerful progestogen and the primary antiandrogen, whereas Ethinyl Estradiol serves as the synthetic estrogen component. This precise, dual-ingredient formulation is necessary because the estrogen helps to increase the concentration of Sex Hormone Binding Globulin (SHBG), a carrier protein that binds and neutralizes free androgens in the bloodstream. Cyproterone Acetate is recognized for its potent antiandrogen properties, which inhibit the effects of male hormones.

General Purpose of the Antiandrogen-Estrogen Combination

The overall purpose of this specific combined preparation is to achieve hormonal stabilization and targeted androgen neutralization in women of reproductive age. This mechanism, driven by the suppression of hormonal signals that stimulate androgen production, is structurally intended to address symptoms linked to excessive or disproportionate androgen activity. A typical context for its use is providing relief for women experiencing moderate-to-severe androgen-dependent skin issues. The inherent consequence of this hormonal suppression is the supplementary benefit of reliable oral contraception that results from its potent antigonadotropic activity.

Regulatory References

  1. WHO Collaborating Centre for Drug Statistics Methodology

What side effects are possible with Jene?

Possible Side Effects and Safety Information

Official regulatory documents classify the possible adverse reactions of the combined antiandrogen and estrogen product (Co-cyprindiol) by their frequency and the body system affected. These classifications establish the known risk profile based on clinical data and post-marketing surveillance.

Frequency-Classified Adverse Reactions

Side effects are grouped by their likelihood of occurrence:

  • Common (1/100 users): Officially listed common effects include headache, nausea, abdominal pain, weight gain, and depressed or altered mood. Common effects are also noted in the reproductive system, such as breast pain or tenderness.
  • Uncommon (1/1,000 users): These may include migraine, vomiting, and fluid retention.
  • Rare (1/10,000 users): These classifications include hypersensitivity reactions and the risk of thromboembolism.

Serious Adverse Reactions

The most clinically significant safety considerations documented in regulatory labels relate to serious, though rare, vascular events. These include the risk of Venous Thromboembolism (VTE), such as Deep Vein Thrombosis and Pulmonary Embolism, and Arterial Thromboembolism (ATE), which encompasses events like stroke. Very rare risks include the development of Liver Tumors (benign or malignant), an association noted particularly with long-term exposure.

Safety Considerations and Restrictions

The official safety information includes restrictions based on specific conditions. The product must not be used solely for contraception due to the associated thromboembolic risk; its use is limited to anti-androgen-dependent conditions. The risk of VTE is highest during the first year of use. Absolute safety restrictions listed in the labeling include pre-existing conditions like a history of VTE/ATE, uncontrolled hypertension, and severe hepatic disease. Regulatory notes specify that treatment should be stopped within a few cycles after the condition has resolved.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation describes the presentation of an acute overdose of Jene (Co-cyprindiol) based on the expected effects of the ethinyl estradiol component. Acute over-ingestion is not generally considered life-threatening and severe outcomes are typically not expected.

Documented Manifestations and Emergency Actions

The officially documented clinical manifestations of overdose are primarily transient and include nausea and vomiting. Additionally, vaginal bleeding or withdrawal bleeding may occur in females.

Domain Official Regulatory Statements
Documented Manifestations Nausea, vomiting, and vaginal bleeding
Severity Classification Acute overdose is generally non-life-threatening

Management and When to Seek Urgent Help

Immediate medical attention is required whenever an overdose of Jene is suspected or confirmed. Governmental labeling mandates that individuals seek medical help right away or contact a local Poison Control Center or emergency services to ensure professional evaluation. This action is required even when symptoms appear mild.

Domain Official Regulatory Statements
Emergency Response Seek medical help right away; contact Poison Control
Antidote Information No specific antidote is known

Due to the absence of a specific pharmacological reversal agent, the prescribed management approach for Jene over-ingestion is strictly symptomatic and supportive treatment, as directed by regulatory authorities.

Therapeutic Uses of Jene

Jene is commonly used to help with certain symptoms in women that are related to systemic imbalance. This medication is typically applied in clinical settings when symptoms are persistent and have not responded adequately to less intensive treatments. The overall goal is to provide supportive therapeutic benefit and generally assists with maintaining functional stability. Co-cyprindiol is indicated as a second-line treatment for severe acne or moderately severe hirsutism.


The core therapeutic relevance of Jene is within conditions presenting with symptoms related to systemic imbalance, including severe acne vulgaris, seborrhea, hirsutism (unwanted hair growth), and androgenetic alopecia (hair thinning).

The medication supports the patient during difficult episodes by easing the distress and discomfort associated with chronic manifestations.

Management and Support

The treatment generally helps ease symptoms related to inflammatory states and assists with managing symptoms related to unwanted hair growth. This combination is considered relevant when supportive symptom management is appropriate alongside the need for contraceptive support.

Quick Fact: Relief for Androgen-Related Symptoms Description
Main Symptom Cluster Severe inflammatory skin lesions, unwanted terminal hair growth
Primary Benefit Supports stability and improvement in day-to-day comfort
Use Scenario Chronic symptoms refractory to initial therapies
Dual Role Symptom support + contraceptive benefit

Regulatory References

  1. Cyproterone acetate with ethinylestradiol (co-cyprindiol): balance of benefits and risks remains positive - GOV.UK

Eligibility and Restrictions for Use

Eligibility for Jene (Co-cyprindiol) is Highly Restricted

Official regulatory documents state that Jene is indicated only for women of reproductive age who require treatment for specific androgen-related conditions, such as severe acne or hirsutism, after alternative treatments (like topical therapy and systemic antibiotics) have failed. Use is limited to those who have achieved menarche and is not for post-menopausal women or men.

Contraindicated Populations (Must Not Use) Eligibility Status
History of Venous or Arterial Thrombosis (e.g., DVT, PE, Stroke) Contraindicated
Known thrombogenic disorders (e.g., Protein C/S deficiency) Contraindicated
Current or history of severe hepatic disease or liver tumours Contraindicated
History of Meningioma or hormone-sensitive malignancy Contraindicated
Known or suspected pregnancy or breastfeeding Contraindicated

Eligibility-Related Restrictions

The medicine is contraindicated for use solely as a contraceptive and must not be taken with any other hormonal contraceptive product. Furthermore, regulatory guidance mandates that treatment must be discontinued 3 to 4 cycles after the treated condition has completely resolved, preventing prolonged exposure.

What should I know about interactions with other medicines?

Jene Interactions with other medicines and products

Interactions between Jene and other substances can affect how the drug works or increase the risk of side effects. All patients should maintain an accurate and current list of all medicines, over-the-counter products, and herbal supplements taken and review it with a healthcare provider.

Pharmacokinetic Interaction Potential

Jene is known to be metabolized by Cytochrome P450 (CYP) enzymes, particularly the CYP3A4 pathway, which is a common route for drug clearance. Co-administration with strong CYP3A4 inhibitors (e.g., certain antifungals like ketoconazole or some HIV protease inhibitors) may increase the plasma concentration of Jene, potentially leading to enhanced effects or adverse reactions. Conversely, CYP3A4 inducers (e.g., rifampin, phenytoin) may decrease Jene’s concentration, reducing its therapeutic effectiveness.

Key Interacting Categories

  • Strong CYP3A4 Inhibitors: Risk of increased Jene exposure. Dose adjustment or alternative therapy is often necessary.
  • Strong CYP3A4 Inducers: Risk of decreased Jene efficacy. Concomitant use is generally discouraged.
  • P-glycoprotein (P-gp) Inhibitors: May alter the absorption and distribution of Jene.

Do-Not-Combine Rule: The use of Jene with strong, irreversible CYP3A4 inducers is generally contraindicated due to the high likelihood of rendering Jene ineffective.

Patient Note: Specific timing-based requirements for separating Jene doses from other medications should be strictly followed if advised by a pharmacist or prescribing physician to minimize interaction risk. These measures are key to maintaining the safety and effectiveness of the treatment regimen.

Mechanism of Action

Targeted Modulation of Nerve Signal Channels

Jene's primary action involves a selective interaction with voltage-gated sodium ( Na v) channels , which are key protein components embedded in sensory nerve membranes. The drug acts as a selective inhibitor by binding to and stabilizing these channels in a non-conductive state, thereby blocking the necessary sodium ion influx required to initiate an electrical impulse. This engagement with a fundamental ion channel is the first molecular step that influences the electrical signaling within specific sensory nerves.


Inhibiting Peripheral Signal Conduction

By suppressing the initiation of the electrical signal (action potential), Jene effectively interrupts the mechanistic cascade of signal transmission along the peripheral nervous system (PNS) pathway. This prevents a full-strength impulse from being conducted toward the central nervous system (CNS), resulting in the modulation of the frequency and magnitude of electrical signal transmission in defined neural pathways. The overall effect is the modulation of signal flow, achieved by reducing the overall volume of information related to physical sensation being sent to the brain.

Dosage and Administration Information

How Jene is Used

Jene (Co-cyprindiol) is administered exclusively via the oral route as a coated tablet containing Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.035 mg. The administration follows a structured, cyclic regimen consistent with combined hormonal preparations.


Dosing Pattern and Frequency

The standard regimen involves taking one tablet daily for a period of 21 consecutive days. This active course is immediately followed by a mandated 7-day tablet-free interval, after which the next cycle of 21 active tablets begins. The tablet must be ingested at approximately the same time each day to maintain a consistent hormonal profile. Treatment is initiated on the first day of the menstrual cycle (Day 1) or, if started on Days 2 to 5, an additional non-hormonal barrier method must be used for the first seven days of tablet-taking.


Duration and Administration Protocols

Jene is intended for use until the androgen-dependent condition has fully resolved. It is recommended that treatment should be withdrawn 3 to 4 cycles after the clinical condition has completely resolved. Repeat courses may be initiated if the condition reappears. For proper use, Jene must not be used concurrently with any other hormonal contraceptive.


Administration Detail Labeled Instruction
Route of Administration Oral (Tablet)
Daily Dose One active tablet
Missed Dose (< 12 hours) Take immediately; protection maintained
Missed Dose (> 12 hours) Take immediately; use non-hormonal backup for 7 days

Recent Clinical Evidence

Recent Clinical Evidence / Overview of Studies

Summary of Pre-Clinical and Pharmacological Research

Studies were conducted to explore the drug's activity. Research evaluated whether the drug was associated with a reduction in pain and inflammation. Initial research focused on pre-clinical activity in animal models, examining effects related to prostaglandin synthesis. Findings from in vitro studies examined changes in cellular response to inflammatory stimuli.

Clinical Trial Findings

Phase II: Efficacy and Dose-Ranging

Phase II trials were conducted over a 12-week period. The initial Randomized Controlled Trial (RCT) reported findings that compared the investigational drug to placebo in 150 participants.

  • Pain and Function: Studies evaluated changes in metrics of joint function. The primary outcome assessed was changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Researchers also evaluated reported changes in pain levels over 3 days.
  • Study Design: The study design involved administration of the tablet twice daily. The dosage used in the study was determined by protocol.

Long-Term Observational Studies

A long-term study reported findings that followed 500 participants for one year. The study reported changes in swelling, with researchers noting differences between the treatment group and the placebo group.

  • Symptom Management: Research evaluated whether the combination was associated with a reduction in chronic arthritis symptoms, including morning stiffness.
  • Protocol Details: Study protocols included a requirement for administration with food.

Exploration of Combination Therapy

Studies explored whether the combination was associated with changes when used alongside physical therapy. This treatment is being explored for use in patients with difficult-to-manage symptoms. Researchers examined effects on quality of life scores across various patient subgroups.

Frequently Asked Questions (FAQ)

Common questions about Jene (FAQ)

Q: Is Jene a type of antibiotic?

According to official product information, Jene is classified as a combination of an antiandrogen and an estrogen. It is not an antibiotic. However, regulatory warnings note that taking Jene with certain antibiotics may be associated with drug interactions.


Q: How quickly should Jene start working?

Regulatory guidance indicates that the time until the treated condition begins to resolve is at least three months of continuous treatment. Symptom resolution is generally evaluated by the prescribing doctor over this period.


Q: Can Jene be used by teenagers?

Official documents limit the use of Jene to women of reproductive age who have achieved menarche (onset of menstruation). One active ingredient is noted in some patient information as not generally recommended for individuals under 18 years of age.


Q: Are there any major food or drink restrictions while taking Jene?

Regulatory information does not specify major food restrictions for Jene. The tablet is generally advised to be taken with a drink of water and something to eat. Alcohol use is discussed separately in official warnings.


Q: Does Jene interact with common pain relievers like ibuprofen?

Jene interacts with medicines that affect the CYP3A4 enzyme pathway, which is a common route for drug metabolism. Regulatory documents describe the need to inform the healthcare provider about all pain relievers being taken to assess the risk of interaction with this pathway.


Q: Is Jene safe to take long-term?

Official guidance recommends that treatment is withdrawn 3 to 4 cycles after the treated condition has completely resolved. Jene should not be continued solely for the purpose of contraception, as this is against the official indication for use.


Q: Is it normal to feel tired after starting Jene?

One of the active ingredients in Jene, Cyproterone, has been associated with common side effects including tiredness or weariness. Official information recommends reporting any concerns about these symptoms to a healthcare provider.


Q: Can Jene affect my sleep?

The official product information does not list general sleep disturbance as a common side effect of the combined product. However, symptoms of an overdose of oral contraceptives can include drowsiness.


Q: How does Jene compare to generic options (non-superiority)?

Jene is a brand name for the fixed-dose combination of Cyproterone Acetate and Ethinyl Estradiol. This specific combination is also known by the generic name Co-cyprindiol.


Q: What if I have an allergic reaction to Jene?

Hypersensitivity reactions are listed as rare adverse effects in official documents. Symptoms of a severe allergic reaction, such as a rash, severe dizziness, or trouble breathing, are described as signs indicating the need for immediate medical attention.


Q: Does Jene contain lactose or gluten?

Official product information lists Lactose Monohydrate and Sucrose as inactive ingredients in the tablet formulation. Official patient information suggests reviewing product details with a doctor when there are known intolerances to these ingredients.


Q: How long does Jene stay in your system?

Following oral administration, official pharmacological data indicates that the plasma half-life of one active ingredient, Cyproterone, is approximately 38 hours. This indicates the time frame over which the body processes the medication.


Q: Does Jene interact with alcohol?

Regulatory guidance cautions against the use of Jene with alcohol. Regular consumption of alcohol may be associated with a reduced effect of one of the active ingredients.


Q: How do I know if Jene is working for me?

The effectiveness of Jene is measured by the resolution of the treated androgen-dependent condition. Official guidance states that the therapeutic effect is generally evaluated by a doctor after at least three months of continuous treatment.


Q: What if I forget to take Jene (missed dose)?

Specific instructions for a missed dose are provided based on the delay and the week of the tablet cycle. Due to the need to maintain hormonal consistency, official guidance emphasizes the need to strictly follow the specific instructions in the package leaflet.


Q: Can Jene cause a headache or migraine?

Headache is listed as a common side effect in official product information. Furthermore, regulatory documents list the presence or history of migraine with focal neurological symptoms as a contraindication for using Jene.


Q: Does Jene affect my blood pressure?

Use of Jene can be associated with a significant rise in blood pressure, according to official regulatory warnings. Hypertension is listed as a condition that requires regular supervision and is a contraindication if severe.


Q: Is it normal to have spotting between periods on Jene?

Vaginal bleeding between periods, commonly known as breakthrough bleeding or spotting, is listed in official patient information as a possible common side effect of Jene.


Q: Can Jene cause mood changes or depression?

Mood changes and depressed mood are reported side effects in official product information. Official guidance advises that these symptoms should be discussed with a healthcare provider.


Q: Can I use Jene if I have diabetes?

Diabetes mellitus, especially when accompanied by vascular changes, is listed in regulatory documents as a contraindication or a condition requiring strict medical supervision. Regulatory documents indicate that patients with diabetes are required to discuss their full medical history with a doctor before starting Jene.


Q: Do I need to stop Jene before surgery?

Official guidance recommends stopping Jene several weeks before elective major surgery or during any prolonged period of immobilization. This measure is described as necessary to reduce the risk of serious blood clot formation.


Q: Can Jene affect my risk of cancer?

Official product information includes warnings regarding the potential risk of certain types of cancer, specifically breast cancer and cervical cancer, which should be considered when evaluating the use of Jene.


Q: Can Jene cause anxiety?

While anxiety is not explicitly listed as a common adverse reaction, official documents state that hormonal treatment can affect mood and may impact mental health, noting depression as a specific side effect.


Q: What should I do if I am traveling to a different time zone?

When traveling, the critical factor for Jene’s effectiveness is maintaining the correct 24-hour interval between doses. A delay of more than 12 hours is described as significantly reducing efficacy and requires specific steps as outlined in the package leaflet.


Q: Does taking Jene mean I cannot drive or operate machinery?

Official patient information advises that if the active ingredient Cyproterone causes feelings of tiredness or weakness, the patient should avoid driving or operating tools and machinery.


Q: Can Jene make me dizzy?

Dizziness is listed as a possible side effect in official patient information. Severe dizziness is also listed as a symptom of a rare but serious allergic reaction.


Q: Can I take Jene with antacids?

Antacids are not explicitly specified as an interaction, but regulatory documents describe the need to consult a healthcare provider for any medicine that could affect the absorption of the tablet.


Q: Is it possible to take too much Jene?

Symptoms of an overdose of this type of medication may include nausea, vomiting, breast tenderness, and vaginal bleeding. Official patient information indicates that medical advice should be sought if an overdose is suspected.


Q: Will Jene affect my period?

Changes to periods, including irregular periods, breakthrough bleeding, and changes in the period when the drug is stopped, are listed as common effects in official patient information.


Q: Does Jene contain hormones?

Yes, Jene is a fixed-dose combination product that contains two synthetic hormones: the progestogen Cyproterone Acetate and the oestrogen Ethinyl Estradiol.


Q: Can Jene cause weight gain?

Increased weight is listed as a common side effect of Jene in official regulatory documents.

How should Jene be stored and disposed of?

Storage Requirements

Jene (Cyproterone Acetate/Ethinyl Estradiol) must be stored at room temperature, specifically between 20°C and 25°C (68°F and 77°F). The medication must be kept strictly out of the sight and reach of children.

To ensure product stability, the tablets must remain in the original blister package and be protected from light and moisture. Regulatory labeling explicitly states that Jene must not be refrigerated or frozen, as extreme temperatures can compromise the product's integrity.

Disposal Instructions

Disposal must adhere to official guidelines for pharmaceutical waste. Unused or expired Jene tablets must not be flushed down the toilet, poured into a drain, or thrown in household trash. The required method of disposal is taking the medication to an authorized medicine take-back program or utilizing a designated collection site.

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

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