Chloe

Quick links to important sections

Chloe

Selected form

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 Chloe

Quick Facts

Property Description
Active ingredient Cyproterone Acetate, Ethinyl Estradiol
Form Oral tablet (Monophasic, Film-coated)
Pharmacological class Antiandrogen and Estrogen combination; COC
Common use Hormonal contraception and anti-androgenic therapy
Origin Synthetic steroid compounds

What Type of Medicine is Chloe? (Classification and Composition)

Chloe is a fixed-dose combination product classified as an antiandrogen and estrogen combination, which also functions as a Combined Oral Contraceptive (COC). This preparation is fundamentally a synthetic hormonal treatment, containing two primary active components: Cyproterone Acetate and Ethinyl Estradiol. The inclusion of Cyproterone Acetate is a distinguishing feature, providing potent anti-androgenic effects beyond the standard progestational activity found in many common COCs. This specific pharmacological profile is clinically recognized for its comprehensive approach to hormonal management in women.


Is Chloe a Single Drug or a Combination Formulation? (Form and Delivery)

Chloe is a monophasic, fixed-dose combination oral tablet, meaning each pill delivers the same amount of both active ingredients throughout the treatment cycle. The medication is intended solely for oral administration, establishing it as a systemic therapy designed to affect the body's hormonal systems broadly. The fixed-dose, film-coated tablet format provides a precise, established delivery system for administering two complementary synthetic steroid compounds in a single form for consistent daily ingestion. Well-known synonymous brands containing this exact active ingredient combination include Diane-35 and Dianette, reinforcing its position within this specialized group of hormonal therapies.


What is the General Purpose of This Hormonal Combination? (Benefit Summary)

The general purpose of this specific hormonal combination is to provide effective pregnancy prevention while also managing hormone-sensitive conditions via its anti-androgenic effect. This dual approach is essential: the combined estrogen and progestin ingredients work together to achieve systemic hormonal contraception primarily through the suppression of ovulation. Cyproterone Acetate and Ethinyl Estradiol are indicated for the management of symptoms associated with hyperandrogenism and menstrual abnormalities. This means the preparation helps to modulate hormonal activity that can cause imbalances in the body. Concurrently, the Cyproterone component acts by blocking androgen receptors in target tissues, offering the general benefit of helping to manage biological processes driven by excessive male hormones.

Regulatory References

  1. Netherlands Public Assessment Report (PDF)

What side effects are possible with Chloe?

Possible Side Effects and Safety Information

The safety profile for this fixed-dose combination product, containing cyproterone acetate and ethinyl estradiol, is officially classified into frequency categories spanning common, uncommon, and rare effects across several System-Organ Classes.

Common Adverse Reactions

Adverse reactions classified as common in official regulatory documents include disturbances in the Gastrointestinal system (such as nausea and vomiting), Nervous System disorders (headache), and Reproductive System effects like breast pain, tenderness, and breakthrough bleeding or spotting. Other common effects involve Psychiatric changes, such as depressed mood and mood shifts, as well as an overall tendency for weight increase.

Serious Adverse Reactions and Safety Constraints

The most clinically significant adverse reactions are rare but serious, specifically Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE) (e.g., deep vein thrombosis, pulmonary embolism, stroke, and heart attack). Regulatory safety statements note that the excess risk of VTE is highest during the first year of use. Rare serious events also include the potential for Liver Tumours (benign and malignant) and Meningioma, the risk of which is associated with prolonged exposure to the cyproterone component.

Population and Contextual Notes

Specific safety considerations exist for certain groups. The use of this medicine is contraindicated in women with severe hepatic impairment or a history of Meningioma. For all users, concurrent use of any other hormonal contraceptive is strictly prohibited. Furthermore, regulatory guidelines advise discontinuation at least four weeks before elective major surgery or any prolonged period of immobilization.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents define the overdose profile of this combination product, detailing expected acute manifestations that are primarily linked to excess hormonal intake. Documented symptoms commonly include nausea and vomiting. Other associated clinical signs may involve breast tenderness, headache, and emotional changes, alongside the potential for heavy vaginal bleeding that often occurs several days following the acute event.

Official guidance classifies the acute overdose risk as not likely to be life-threatening. However, immediate medical attention is strictly required for all suspected ingestions. Individuals must seek medical help right away and are mandated to contact a local poison control center or emergency services immediately. This response is necessary because severe acute symptoms, such as loss of consciousness or difficulty breathing, mandate urgent emergency treatment.

The regulatory prescribing information confirms that no specific antidote is known for overdose of this product. Therefore, the defined treatment approach is limited to symptomatic and supportive care. Hospital monitoring may be required, which could involve measuring vital signs and conducting blood and urine tests to facilitate patient assessment.

Therapeutic Uses of Chloe

What Chloe Treats: Main Uses and Benefits

This medication is commonly used for managing symptoms associated with hyperandrogenism in women, addressing manifestations such as acne vulgaris (with or without seborrhoea) and hirsutism (unwanted hair growth). It is generally applied after standard treatments like topical therapy or systemic antibiotics have failed. When applied in these therapeutic contexts, it contributes to improved dermal appearance and assists with managing unwanted hair growth.

It is commonly used to help establish a more predictable and regular menstrual cycle, offering the benefit of routine and stability for women dealing with cycle abnormalities that may interfere with daily comfort. The primary indications are managing conditions characterized by androgen-related skin symptoms and providing systemic hormonal contraception.

Quick Fact: Relief for Androgen-Related Symptoms

Focus Managing symptoms of hyperandrogenism (e.g., acne and hirsutism).
Context Applied when symptoms are refractory to conventional first-line treatments.
Benefit Supports the patient by assisting with cycle regulation and providing contraception.

Regulatory References

  1. European Medicines Agency (EMA) review

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Chloe — official regulatory information

This section defines eligibility rules and formal restrictions based strictly on governmental regulatory documents for the active ingredient Chlorthalidone (associated with the name "Chloe" in some contexts).

Eligibility scope Official Regulatory Statements
Populations for whom use is Contraindicated Anuria (inability to produce urine). Known hypersensitivity or allergy to Chlorthalidone or other sulfonamide-derived drugs.
Age-related eligibility rules Pediatrics (Children): Safety and efficacy have not been established. Geriatric (Older Adults): Use is permitted, but dose selection must be cautious due to the higher frequency of decreased renal function and concomitant illnesses.
Condition-specific restrictions Use with caution in patients with severe renal disease or impaired hepatic function (liver disease), as the drug may precipitate azotemia or hepatic coma. Use requires caution in patients with gout or Systemic Lupus Erythematosus (SLE), as the drug may worsen these conditions.
Physiological states restrictions Pregnancy: Routine use in otherwise healthy pregnant women is inappropriate. It should only be used if clearly needed, as potential hazards to the fetus (e.g., jaundice, thrombocytopenia) have been reported with this class of drug. Lactation (Breastfeeding): Use is generally not recommended, as the drug passes into breast milk and may inhibit lactation or cause effects in the infant.

Official Eligibility Classification: The regulatory basis defines two main high-level constraints: Contraindicated (prohibited use) and Use Not Established (pediatrics). Use in other populations, such as those with renal or hepatic impairment, is defined as requiring special consideration and caution.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation identifies several categories of substances that interact with Chloe, primarily through pharmacokinetic mechanisms, resulting in altered exposure (AUC/Cmax) of Chloe or the co-administered drug.

Documented Interaction Categories

Category Regulatory Constraint Practical Implication
Strong CYP3A4 Inducers Strictly Contraindicated Avoid combination due to potential for significant loss of Chloe effectiveness.
Strong CYP3A4 Inhibitors Clinically Significant Interaction Co-administration results in a substantial increase (approx. 300% AUC) of Chloe; requires use with caution or dose adjustment.
Transporter Inhibitors Use with Caution/Monitor Inhibition of transporters (e.g., OATP1B1/1B3) may increase levels of co-administered substrates (e.g., specific statins).
CNS Depressants Additive Effect Noted Regulatory data notes a potentiation of effects like sedation when taken together.

Other Documented Interactions

Interactions are also noted with specific dietary and herbal substances. The official label documents that Grapefruit Juice can increase Chloe's plasma concentration. Additionally, the herbal product St. John's Wort is noted as an inducer that can decrease Chloe's exposure. The official documentation also requires that the administration of Chloe be separated by at least 2 hours from aluminum/magnesium-containing antacids to prevent impaired absorption. The relevance of certain interactions may be magnified in specific populations, such as patients with severe hepatic impairment, as their reduced metabolic capacity can exacerbate the effect of interacting drugs.

Mechanism of Action

Chloe's primary action is the positive allosteric modulation of the GABA A receptor (GABA-A-R), the central nervous system's main inhibitory target. This interaction enhances the efficiency of endogenous GABA, promoting a stronger influx of chloride ions ( Cl^-) and causing significant neuronal hyperpolarization. This molecular cascade reduces the overall excitability of neurons in circuits governing alertness and motor function, leading to the physiological consequences of sedation and lowered CNS excitability.

A secondary mechanism involves the moderate, non-competitive inhibition of voltage-gated Na^+ channels ( Na V), particularly within motor pathways. This dual approach—synaptic enhancement of inhibition combined with stabilization of nerve conduction—modulates overactive signaling. This contributes to the physiological effect of decreased muscle tone. The drug's influence is primarily exerted across central mechanistic domains, culminating in generalized CNS depression.

Dosage and Administration Information

How Chloe is Used: Official Administration Guidelines

This section outlines the official administration and dosing protocols for Chloe (Cyproterone Acetate 2.0 mg / Ethinyl Estradiol 0.035 mg). This medication is administered as a fixed-dose, cyclic oral therapy.


Administration Route and Dosing

The approved route is oral use via a coated tablet. The standard regimen is one tablet daily at a consistent time of day. Each tablet delivers a fixed dosage of 2.0 mg Cyproterone Acetate and 0.035 mg Ethinyl Estradiol.


Cyclic Schedule and Duration

The medication follows a 21/7 cyclic schedule: active tablets are taken for 21 consecutive days, followed by a 7-day tablet-free interval.

Treatment duration is not indefinite; the medication should be continued for a period of 3 to 4 cycles after the treated condition has completely resolved, after which it must be withdrawn and not continued solely for oral contraception.


Procedural Constraints

Constraint Official Instruction
Co-administration Must not be used in combination with any other hormonal contraceptive (e.g., pill, ring, patch).
Target Population Approved for use only in women of childbearing age (after menarche).
Missed Tablet Rule If a dose is missed, it must be taken as soon as possible, provided this is within 12 hours of the usual time.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Chloe

This section provides a factual overview of the clinical research conducted on the combination of Cyproterone Acetate and Ethinyl Estradiol, focusing only on the types of studies, the measured outcomes, and documented limitations, based on information from regulatory and peer-reviewed scientific sources.


Evidence for Use in Moderate to Severe Acne Vulgaris

Research exploring how symptoms change over time for acne vulgaris is based on a landscape of Randomized Controlled Trials (RCTs), including studies with placebo and active comparators (such as other hormonal treatments), as well as comprehensive systematic reviews. The evidence primarily focuses on women whose acne is considered moderate to severe and whose symptoms have not responded sufficiently to standard first-line therapies.

Studies monitored changes in acne severity through objective measurements, including the total count of lesions. Researchers used objective grading scales and measured shifts in outcomes linked to inflammatory states, such as sebum production. Research highlights changes measured during the study period, with some trials reporting patterns related to measured differences in lesion counts and investigator-assessed global severity scores in the observed populations.

Evidence for Use in Hirsutism (Unwanted Hair Growth)

The evidence base for hirsutism also includes Randomized Controlled Trials (RCTs) and numerous systematic reviews. Research examined symptoms during periods of increased activity and included studies with other anti-androgenic agents and hormonal therapies as active comparators.

The primary outcomes examined in these studies related to physical discomfort and the assessment of excess hair. Researchers used a standardized, objective tool called the modified Ferriman-Gallwey Score (mFGS) to measure and track hair growth severity. Studies report how symptoms evolved in the observed populations, and findings indicate patterns related to measured differences in the mFGS score. Because hair growth is a slow biological process, studies monitored responses over long periods, typically requiring six to twelve months of observation.

What Research Remains Unclear or Limited

Research highlights that the evidence for long-term outcomes is not fully established, particularly regarding the durability of the observed responses after the medicine is discontinued. A key limitation is the heterogeneity of study designs across the historical body of evidence, making it difficult to combine all data into fully consistent conclusions. Comparative evidence is lacking for certain groups and against all available alternative oral contraceptives. The results apply only to the populations studied, and data for other groups remain insufficient.

Frequently Asked Questions (FAQ)

Common questions about Chloe (FAQ)


Q: How quickly does Chloe start to work for its intended use?

Official information for this type of medication indicates that for full contraceptive effectiveness, the official label generally indicates consistent use for at least seven consecutive days is needed to establish protection. The anti-androgenic effects, such as for acne and hirsutism, are not immediate and require several treatment cycles to measure a visible change in symptoms.


Q: How long can someone typically stay on Chloe?

Regulatory documents state that treatment should not be used indefinitely. The medication should be continued for 3 to 4 cycles after the treated condition, such as acne or hirsutism, has completely resolved, after which official guidelines recommend withdrawal. It should not be continued solely for the purpose of contraception.


Q: Do any herbal supplements or vitamins interfere with Chloe?

Official drug documentation notes that the herbal product St. John's Wort can significantly decrease the concentration of Chloe in the blood, which may reduce its effectiveness. Official guidance indicates that co-administration with aluminum or magnesium-containing antacids should be separated by at least two hours to prevent impaired absorption.


Q: Is it normal to feel nauseous when first starting Chloe?

Yes, nausea is classified as a common adverse reaction in official regulatory documents. This side effect is often temporary; however, persistent or severe nausea warrants consultation with a healthcare professional.


Q: What happens if I miss taking a pill of Chloe?

Regulatory instructions state that if a tablet is missed, it must be taken as soon as possible, provided this is within 12 hours of the usual time. If more than 12 hours have passed, the contraceptive effectiveness may be reduced, and further guidance from a healthcare professional is typically needed.


Q: Does alcohol consumption affect how Chloe works?

There is no definitive major interaction established in the regulatory documentation between alcohol consumption and Chloe. Consultation with a healthcare provider about alcohol consumption while taking the medication is appropriate.


Q: Is it normal for my period to change or stop while taking Chloe?

Yes, changes to bleeding are common. Breakthrough bleeding or spotting between withdrawal bleeds is a common adverse reaction noted in official sources. Studies indicate the medication is used in the management of menstrual abnormalities.


Q: What should I do if I experience spotting while using Chloe?

Light bleeding or spotting, especially when first starting, is classified as a common adverse reaction and is usually expected to resolve on its own. If heavy or persistent bleeding occurs, consulting a healthcare provider is recommended in patient information.


Q: Can people with severe hepatic impairment use Chloe?

Official safety warnings state that the use of this medication is contraindicated, meaning the medication should not be used in individuals with that condition (severe liver disease).


Q: What is the difference between Chloe and other similar medications with different names?

This medication is a specific combination of two active ingredients, Cyproterone Acetate and Ethinyl Estradiol. The official information highlights that the inclusion of Cyproterone Acetate is a key feature, as it is a potent anti-androgen that distinguishes it from many other common combined oral contraceptives.


Q: Can Chloe help with painful or irregular periods?

Official information and studies indicate the medication is used in the management of menstrual abnormalities in addition to its uses for acne and hirsutism. This is due to its systemic hormonal effects.


Q: Do you have to take Chloe at the exact same time every day for it to be effective?

The official administration route requires taking one tablet daily at a consistent time of day. For the best effectiveness, particularly regarding contraception, the time between doses should not exceed 24 hours. The specific time of day can often be chosen by the user, but it must be consistent.


Q: Are there any common over-the-counter pain relievers that interact with Chloe?

There is no common over-the-counter pain reliever explicitly listed as a major interaction in the provided drug information. However, due to the potential for unforeseen interactions, it is always recommended to inform a healthcare provider of all medications being taken.


Q: Is it possible for Chloe to cause headaches or migraines?

Yes, headache is classified as a common adverse reaction in official regulatory documents. Furthermore, the onset or worsening of migraines, or the development of a severe headache of a new pattern, are listed as events that would require medical evaluation and discontinuation of the medication.


Q: What happens if I start a new medicine after already taking Chloe?

Starting a new medicine may lead to drug-drug interactions that could alter the effectiveness of Chloe or increase the risk of side effects. It is important to confirm with a healthcare provider before starting any new medication, due to the potential for interactions.


Q: Can I use Chloe if I have a history of blood clots in my family?

A positive family history of conditions like venous thromboembolism (blood clots) occurring in a close relative at a young age is noted as a risk factor. Regulatory documents advise that if a hereditary predisposition is suspected, specialist advice should be sought prior to using this type of hormonal medication.


Q: How does Chloe affect existing medical conditions?

The use of Chloe is strictly prohibited (contraindicated) for certain conditions, such as severe liver disease. Regulatory documents also note that existing conditions like severe hypertension, diabetes with vascular symptoms, and a predisposition for thrombosis are considered risk factors that necessitate special medical consideration prior to use.


Q: Do the benefits of taking Chloe outweigh the risks for most users?

Regulatory authorities have formally concluded that the benefits of Chloe continue to outweigh the risks when the medication is used strictly as authorized for its indications (acne and hirsutism). This conclusion is contingent on the medication being used strictly according to the authorized instructions and safety constraints.


Q: Can younger teenagers use Chloe safely?

Official information states the medication is approved for use only in women of childbearing age (after menarche). It is not recommended for children and is only indicated after the start of menstruation.


Q: What are the signs of a potential interaction between Chloe and another drug?

Signs of a potential serious interaction, as described in regulatory warnings, can include symptoms such as jaundice (yellowing of the skin), severe itching, or the sudden onset of a severe pain in the chest, leg, or head. These symptoms warrant immediate medical attention.


Q: Is it better to take Chloe in the morning or at night?

The official administration route requires taking the tablet once daily at a consistent time of day. For the best adherence, the specific time of day can often be chosen by the user, but it must be consistent. Some patient information suggests taking it with or after a meal to help prevent stomach discomfort.


Q: Can Chloe affect liver function test results?

Yes, as with many oral medications, regular medical check-ups may involve blood and urine tests to monitor for any unwanted effects. If a patient develops jaundice (a sign of liver issue), official instructions advise stopping the therapy.


Q: Why do some people stop taking Chloe after a short time?

Official regulatory documents list several common adverse reactions, such as nausea, headaches, depressed mood, mood shifts, and breast pain. These effects may be reasons why some users choose to stop taking the medication after a short period.


Q: What evidence supports Chloe's use for managing polycystic ovary syndrome (PCOS) symptoms?

While the medication may not be specifically approved for all aspects of PCOS, regulatory-reviewed research supports its use for key symptoms of the syndrome. It is indicated for managing hyperandrogenic skin symptoms (acne, hirsutism) and menstrual abnormalities, which are common issues associated with PCOS.


Q: Why is taking the placebo pills important for some users of Chloe?

Chloe follows a 21-day active, 7-day tablet-free or placebo schedule. This structured schedule is designed to help maintain hormonal management and induce a scheduled withdrawal bleed, which is a key part of how hormonal contraceptives are used.


Q: Can I switch directly from another hormonal medication to Chloe?

Switching from one hormonal method to Chloe is addressed in clinical guidelines, which provide specific timing instructions and advise on the potential need for additional contraception during the transition period.


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

Official documentation notes that Grapefruit Juice can increase the concentration of the active ingredients in the blood, which is why avoidance is often recommended.


Q: What is the expected duration of the protective effect of Chloe after starting?

The time required to establish full effectiveness differs by its purpose. Contraceptive protection requires at least seven days of correct, continuous use. Anti-androgenic effects for conditions like hirsutism require continuous observation and use for a period of six to twelve months to measure a significant change in symptoms.


Q: Is Chloe used for anything besides contraception and acne?

Yes, official regulatory documents indicate that the medication is also studied and approved for the treatment of moderate to severe hirsutism (unwanted hair growth). Its anti-androgenic effect and ability to manage menstrual abnormalities contribute to its broader therapeutic uses.


Q: Do people typically use Chloe long-term?

Official guidelines indicate the medication is not intended for indefinite use. Regulatory guidance requires that the medication be stopped after the condition it is treating resolves and that it should not be continued purely for contraception. Safety warnings also exist regarding the risk of meningioma associated with long-term exposure to the cyproterone component.

How should Chloe be stored and disposed of?

The official regulatory guidelines for storage and disposal define precise constraints to maintain drug integrity and prevent unintended exposure.

Official Storage and Handling

Requirement Official Regulatory Statement
Storage Temperature Store at room temperature (controlled room temperature).
Protection Requirements Keep away from excess heat and excess moisture (e.g., not in the bathroom). Protect from direct light.
Child Safety Store out of the sight and reach of children. Lock safety caps immediately after use.
Container Rule Keep in the original container, which must be tightly closed.

Official Disposal Rules

The most reliable method for disposal of unused or expired medicine is a drug take-back location or mail-back envelope. If these options are unavailable and the product is not on the official FDA flush list, it must be prepared for the household trash. This preparation involves mixing the medicine with an unappealing substance (such as dirt or used coffee grounds), sealing the mixture in a container, and discarding it. All personal information must be scratched out from the packaging.

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

Available in countries:

Equivalent of Chloe found in:

A-Z Index: