Clairette

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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 Clairette

Quick Facts

Property Description
Active Ingredients Cyproterone acetate, Ethinyl Estradiol
Form Oral tablet
Pharmacological Class Combined Antiandrogen-Estrogen
General Purpose Systemic antiandrogenic effect
Origin Synthetic

What is Clairette?

Clairette is a specific pharmaceutical product, known by the generic name Co-cyprindiol, which is a fixed-dose combination of two synthetic hormones. Its primary identity is rooted in its classification as a potent Combined Antiandrogen-Estrogen preparation. This specific formulation is clinically recognized for its systemic antiandrogenic activity in women of reproductive age.

What Type of Medicine is Clairette?

Clairette is an oral, hormonal medicine officially classified under the Anatomical Therapeutic Chemical (ATC) code G03HB01 for antiandrogens and estrogens. As a fixed-dose combination product, the two active ingredients are integrated into a single oral tablet taken by mouth. This combination is used across Europe under various trade names, and its clinical profile involves a systemic treatment effect. The components, Cyproterone acetate and Ethinyl Estradiol, are entirely synthetic steroid hormones, providing a systemic effect rather than a localized one.

The Core Composition: Cyproterone and Ethinyl Estradiol

The medicine is composed of the active ingredients Cyproterone acetate (CPA) and Ethinyl Estradiol (EE). Cyproterone acetate functions as both a progestin and the key antiandrogen, responsible for blocking the specific receptors where natural androgens bind. The addition of Ethinyl Estradiol, a synthetic estrogen, stabilizes the hormonal cycle and contributes to the antiandrogenic effect by increasing Sex Hormone-Binding Globulin (SHBG), which binds and reduces free circulating androgens. This unique dual composition is fundamental to the medicine's identity and its specialized capability for regulating hormonal activity.

General Purpose and Antiandrogenic Benefit

The fundamental purpose of Clairette's composition is to achieve a powerful and comprehensive antiandrogenic effect. This specific formulation is designed to mitigate the physiological impact of heightened or sensitive androgen activity within the body. This product is used in women of reproductive age for symptoms stemming from androgen sensitivity. This establishes the medication's primary, general benefit as the systemic reduction of these hormonal influences on target tissues.

Regulatory References

  1. NIH PubMed Abstract
  2. EMA Referral Final Conclusion

What side effects are possible with Clairette?

Possible Side Effects and Safety Information

The official safety profile of Clairette (Co-cyprindiol) differentiates between common, generally non-serious adverse reactions and rare, serious risks, as categorized in government regulatory documents like the Summary of Product Characteristics (SmPC).

Frequency-Classified Adverse Reactions

Adverse effects are categorized by frequency, based on clinical data. Common reactions (affecting ge 1/100 to <1/10 users) typically include headache, nausea, abdominal pain, depressed mood, changes in weight, and breast tenderness. Uncommon effects (ge 1/1,000 to <1/100 users) may involve vomiting, diarrhea, migraine, changes in libido, rash, and fluid retention. Less frequent effects are classified as Rare or Not Known.

System Organ Class Common Adverse Reactions Uncommon / Rare Adverse Reactions
Psychiatric Depressed mood, Mood altered Libido decreased/increased
Gastrointestinal Nausea, Abdominal pain Vomiting, Diarrhea
Reproductive/Breast Breast pain, Tenderness Breast discharge, Breakthrough bleeding

Serious Adverse Reactions and Safety Constraints

The most serious, though rare, risks highlighted in regulatory warnings are Thromboembolic Events, involving both venous (e.g., Deep Vein Thrombosis, Pulmonary Embolism) and arterial (e.g., Myocardial Infarction, Stroke) blood clots. Regulatory data indicate this risk is highest during the first year of use or when restarting treatment after a break of four weeks or more.

Additionally, due to the Cyproterone acetate component, the label includes a contraindication against use in patients with a previous or current Meningioma (a generally non-cancerous brain tumor). The product is also contraindicated in individuals with a history of any thromboembolic disorder, known hormone-dependent malignancies, or severe hepatic impairment. Official guidance also notes that the cardiovascular risk is heightened for smokers over 35 years of age.

Overdose and Emergency Response

Overdose and When to Seek Help

This section details only the formally documented manifestations of an overdose with products containing Cyproterone acetate and Ethinyl Estradiol (Clairette, or Co-cyprindiol) and the official help-seeking protocols, strictly following government regulatory guidance.

Documented Overdose Manifestations

The most commonly documented clinical presentations following an acute overdose of combined hormonal contraceptives are typically mild and limited to gastrointestinal and hormonal effects. These manifestations include nausea and vomiting. Furthermore, withdrawal bleeding (vaginal bleeding) may occur in female patients a few days after the acute exposure, as noted in official regulatory information.

Regulatory Classification and Emergency Actions

Official regulatory guidance classifies an acute overdose of this product as unlikely to be life-threatening. However, regulators explicitly mandate that patients seek medical help right away if an overdose is suspected. This action includes contacting the national Poison Help hotline or local emergency services for professional advice.

Overdose Component Official Regulatory Status
Severity Classification Unlikely to be life-threatening
Antidote Availability No specific antidote is known
Required Management Supportive symptomatic treatment

Accidental ingestion by children is generally reported in regulatory documents as resulting in minor, self-limited effects, with no serious problems documented. Due to the lack of a specific antidote, management in a healthcare setting is strictly supportive, focusing on monitoring vital signs and addressing symptoms as they occur.

Therapeutic Uses of Clairette

What Clairette Treats: Main Uses and Benefits

Clairette is applied across domains where additional symptomatic support is needed in women of reproductive age. The therapeutic use is centered on managing specific symptoms related to systemic imbalance. The medication is utilized when supportive symptom management is appropriate, such as when prior lines of therapy have not yielded adequate results. It is considered relevant for use in conditions such as moderate to severe acne vulgaris, moderately severe hirsutism (unwanted hair growth), and for managing symptoms associated with Polycystic Ovary Syndrome (PCOS).

Management of Severe Acne and Excessive Oiliness (Seborrhoea)

This medication is commonly used to help with persistent moderate to severe acne in women. This supportive therapeutic benefit helps address chronic, androgen-driven skin manifestations, contributing to easing the overall symptom load through a reduction in blemishes and a decrease in excessive oiliness.

Relief of Androgen-Sensitive Hair Growth and Hormonal Stability

Clairette is relevant for easing symptoms related to moderately severe hirsutism. The application of this therapy plays a role in managing this chronic condition by working to slow the growth rate of new hair. This medication also helps regulate the menstrual cycle, which may assist with establishing a more regular pattern, and is generally used to help with effective oral contraception.


Quick Fact: Relief for Androgen-Driven Symptoms

Symptom Domain Primary Symptom Relief Clinical Contexts
Dermatological Helps address symptoms related to inflammatory or irritative states and excess sebum Applied in clinical settings that involve acute or unstable symptom patterns, when prior treatments failed
Endocrine Supports functional stability by managing hirsutism and cycle irregularity Used in settings marked by temporary physiological imbalance
Reproductive Is generally used to help with effective oral contraception Relevant when supportive symptom management is appropriate

Regulatory References

  1. UK Government Drug Safety Update on Co-cyprindiol

Eligibility and Restrictions for Use

Eligibility Map: Official Population Rules for Clairette

Regulatory documents strictly define the eligible population for Clairette (Co-cyprindiol) and list specific conditions under which its use is prohibited. The medicine is indicated only for women of reproductive age whose severe androgen-driven symptoms, such as acne or hirsutism, have not responded to other established first-line treatments (e.g., topical or systemic antibiotics).


Absolute Contraindications

Clairette is contraindicated and must not be used in the presence of certain high-risk conditions, including:

  • A current or history of venous or arterial thromboembolism (VTE/ATE, such as DVT, PE, or stroke) or prothrombotic disorders.
  • Any history of meningioma, breast cancer, or liver tumours (benign or malignant).
  • Severe or uncontrolled risk factors for thrombosis, such as severe hypertension, diabetes with vascular symptoms, or severe dyslipoproteinaemia.
  • Pregnancy (known or suspected) and lactation.

Age and Concomitant Use Restrictions

The medicine is restricted to use after menarche and is contraindicated in women aged 35 or older who smoke. Furthermore, due to its inherent hormonal activity, Clairette is prohibited for use concurrently with any other hormonal contraceptive.

What should I know about interactions with other medicines?

The official regulatory documents specify several critical interaction patterns for Clairette. Co-administration is formally contraindicated with another hormonal contraceptive due to a substantial increase in the official risk of Venous Thromboembolism (VTE). Concomitant use with specific combinations of Hepatitis C treatments, such as those containing ombitasvir/paritaprevir/ritonavir and dasabuvir, is also strictly prohibited due to the documented risk of liver enzyme (ALT) elevations. Furthermore, the product carries a population-specific restriction noting that use is contraindicated for women over 35 years of age who smoke, based on the significantly increased cardiovascular and thrombotic risks cited in official labels.

The primary basis for drug-drug interaction is pharmacokinetic, revolving around the hepatic enzyme Cytochrome P450 3A4 (CYP3A4). Medicines classified as enzyme inducers speed up the metabolism of Clairette’s hormonal components, which reduces the effective systemic exposure. This interaction pattern is documented with certain anticonvulsants (including phenytoin and carbamazepine), antibiotics (such as rifampicin and griseofulvin), and the herbal product St John’s wort. Conversely, CYP3A4 enzyme inhibitors, like erythromycin or clarithromycin, may cause an increase in the plasma concentrations of the oestrogen component. The medicine Etoricoxib is also documented to increase the overall exposure to ethinyl estradiol. These defined metabolic alterations and prohibition rules strictly define the scope of co-administration.

Mechanism of Action

Dual Action on Androgen Signaling

This component exerts its effect through two distinct mechanistic actions that modulate androgen signaling. First, it acts as a competitive antagonist by binding directly to androgen receptors in peripheral tissues like hair follicles and sebaceous glands, which prevents activation by endogenous androgens. Simultaneously, it engages the Hypothalamic-Pituitary-Ovarian (HPO) axis centrally to suppress the release of gonadotropins. This dual action contributes to a layered modulation of androgen signaling and the resulting physiological effects.


Modulating Tissue Response and Cycle Stability

The observable physiological effects are a direct consequence of these layered mechanistic steps. The receptor blockade and central hormone suppression mechanisms interact to decrease androgen-dependent tissue activity, resulting in reduced sebaceous secretion and a modulation of hair follicle growth rate. Furthermore, the estrogen component provides a constant hormonal level, which suppresses the release of an egg (ovulation) and promotes a predictable stabilization of the uterine lining (endometrium).

Dosage and Administration Information

How to Use Clairette: Official Administration Guidelines

This section outlines the standard protocol for administering Clairette, as established for combined hormonal contraceptives.

Administration Scope

Feature Detail
Route of Administration Oral
Dosing Schedule One active tablet taken daily for 21 consecutive days, followed by a 7-day tablet-free interval.
Timing in Relation to Meals Must be taken at the same time every day, regardless of food intake.
Preparation Requirements None. Tablet is swallowed whole.

Procedural Rules and Missed Doses

Rule Type Official Instruction
Age-Group Rules Prescribed for women of reproductive age.
Starting the Pack Begin the first pack on the first day of the natural menstrual period (first day of bleeding).
Missed Dose (Late <12 Hours) Take the missed tablet immediately. The subsequent tablet should be taken at the usual time. No additional contraception is required.
Missed Dose (Late >12 Hours) Take the last missed tablet immediately (discard any earlier missed tablets). Continue taking the remaining tablets at the usual time, even if two tablets must be taken on the same day. Barrier contraception (e.g., condoms) must be used for the next 7 consecutive days.
Missed Dose in Week 3 If tablets are missed in the third week (days 15-21), the tablet-free interval must be omitted. Finish the current pack and immediately start a new pack the next day.

Connection to the Overall Use Protocol

Administration follows a precise 28-day cyclical pattern. The protocol is structured around maintaining consistent daily oral intake for 21 days to ensure efficacy, followed by a seven-day inactive period. Adherence to the specified timing and the use of compensatory barrier methods for 7 days after a significant dose interruption are established procedural steps to minimize risk.

Recent Clinical Evidence

Research evidence / Overview of studies

This section reviews research findings and studies that have evaluated the drug's properties and examined outcomes related to key symptoms associated with conditions like moderate to severe acne and hirsutism. Research has explored whether the drug, which contains an estrogen and an anti-androgen (cyproterone acetate), is associated with long-term patient outcomes and quality of life. Studies also evaluated the drug's use for managing flare-ups and examined findings related to the onset of effect.


Evaluation of the properties

Research has explored the drug's activity in laboratory and clinical settings, specifically its ability to block the effects of androgens (male hormones) which are thought to stimulate oil production in the skin. Studies examined whether this anti-androgen activity may influence disease processes related to acne and excessive hair growth.

Studies evaluated the safety profile, and some research has compared these findings to those associated with other combined hormonal treatments, particularly concerning the risk of venous thromboembolism (VTE).


Clinical trial evaluations and investigation of symptom findings

Clinical trials have documented findings related to the reduction of acne lesions and severity, and a decrease in excessive hair growth in women of reproductive age.

  • Acne: Multiple clinical trials have demonstrated findings supporting the drug's use in the treatment of moderate to severe acne where the condition is related to hormone sensitivity and has not improved after initial use of topical or antibiotic treatments.
  • Hirsutism: Evidence has also been reviewed for the drug's role in addressing hirsutism (excessive unwanted hair growth).

Studies evaluated the use of this drug in combination with existing therapies, examining relevant clinical outcomes. It is important to note that due to its hormonal components, this drug also acts as an effective contraceptive, and should not be used in combination with other hormonal contraceptives.

Key Studies & References

  1. Cyproterone acetate and ethinylestradiol (Diane-35 and generics) and risk of venous thromboembolism: a systematic review
  2. National Institute for Health and Care Excellence (NICE) Clinical Guideline [NG143] - Acne vulgaris: management

Frequently Asked Questions (FAQ)

Common questions about Clairette (FAQ)

Q: How long does it typically take for Clairette to start working?

A: According to regulatory documents, symptom relief for conditions like acne or hirsutism is typically observed after at least three months of continuous use. The full systemic effect depends on consistent daily intake as outlined in the prescribing information.

Q: Is Clairette considered a short-term or long-term medication?

A: Official guidance indicates that treatment should not be indefinite. The need for continued use is subject to periodic evaluation by a healthcare provider. For instance, use is often discontinued three to four cycles after the condition (e.g., acne) has been controlled.

Q: What should I do if I think Clairette is causing side effects?

A: Regulatory information advises patients to consult their official patient information leaflet for a full list of potential side effects and for guidance on when to seek help. Official channels recommend that all suspected adverse reactions be reported.

Q: Are weight changes a possible side effect of Clairette?

A: Yes, changes in weight are described in regulatory documents as a common adverse reaction associated with this medicine. 'Common' reactions are those that may affect between 1 in 100 and 1 in 10 users.

Q: Does Clairette affect blood sugar levels?

A: Studies examining combined hormonal treatments indicate that the estrogen component may slightly decrease the body's insulin sensitivity. Due to this potential effect, periodic monitoring may be considered for women with existing risk factors for diabetes.

Q: Why do some people need to have blood tests while taking Clairette?

A: Regulatory warnings advise that a medical examination is necessary both before and during treatment to check for risk factors. These examinations may involve checking factors like blood pressure, liver function, and glucose metabolism to help identify potential risks.

Q: What is the difference between brand-name Clairette and a generic equivalent?

A: Regulatory authorities state that a generic equivalent contains the same active ingredients at the same strength. It is required to have the same performance, safety, and effectiveness profile as the brand-name product.

Q: How long does the effect of Clairette last after taking a dose?

A: The active ingredient in Clairette has an elimination half-life of approximately 38 hours, which means the compound stays in the system for some time. This half-life supports the requirement to take the tablet once daily to maintain consistent systemic exposure and efficacy.

Q: Does Clairette affect fertility in men or women?

A: Evidence indicates that the contraceptive effect of the hormonal components is temporary and fully reversible. Available evidence indicates that normal ovulation typically resumes after discontinuation, without diminished long-term fertility being shown.

Q: Is it possible for Clairette to become less effective over time?

A: The official use protocol is structured to ensure continuous efficacy throughout the course of treatment. Regulatory information emphasizes that the tablets must be taken correctly and consistently to maintain contraceptive and therapeutic protection.

Q: Why do doctors say to report a fever right away when taking Clairette?

A: Official regulatory warnings emphasize the rare but serious risk of thromboembolism (blood clots) associated with this class of medication. Any new or concerning symptoms that could potentially be associated with a serious risk should be brought to the immediate attention of a healthcare professional.

Q: What happens if I accidentally take too much Clairette?

A: General guidance for combined oral contraceptives indicates that overdose may cause non-serious effects such as nausea, vomiting, or withdrawal bleeding. In the event a patient believes they have taken too much of the medication, they are directed to contact a healthcare professional.

Q: Can people with kidney problems use Clairette?

A: Regulatory guidance states that combined oral contraceptives are generally not recommended for patients with chronic kidney disease (CKD) due to potential safety risks. Regulatory guidance suggests that alternative methods may be used instead.

Q: Can Clairette be used in children or teenagers?

A: The medicine is officially indicated for use only in women of reproductive age. Use is restricted to after menarche (the start of menstrual periods) and is not intended for use in pre-pubescent children.

Q: Is it safe to drink alcohol while taking Clairette?

A: General regulatory knowledge indicates that alcohol consumption typically does not reduce the effectiveness of the hormones themselves. However, excessive consumption may lead to vomiting or cause patients to forget to take their dose, which could compromise efficacy.

Q: What kind of monitoring is typically done when a person starts Clairette?

A: Regulatory documents advise a thorough medical examination before starting treatment and continued periodic monitoring during use. This typically involves checking for risk factors, including measuring blood pressure and assessing the patient's liver function and glucose metabolism.

Q: Can I stop taking Clairette suddenly, or do I need to taper off?

A: Official guidance on discontinuation states that the use should be stopped approximately three months after the condition being treated is controlled. There is no instruction in the official procedure for tapering off the dose.

Q: Does Clairette affect birth control pills?

A: Regulatory documents strictly state that co-administration with any other hormonal contraceptive is contraindicated. This is due to a substantial increase in the official risk of venous thromboembolism (VTE) when combined.

How should Clairette be stored and disposed of?

Storage Conditions and Requirements

Clairette (Co-cyprindiol) must be stored strictly according to the official regulatory instructions to preserve its stability. The medicine should be kept at a controlled room temperature, generally defined as at or below 30 C (86 F).

The labeling explicitly mandates that the product must not be refrigerated or frozen. The blister strip must be kept in its original outer carton at all times to ensure the tablets are protected from light and moisture. To prevent accidental ingestion, the medicine must be stored out of the sight and reach of children.

Disposal Instructions

Expired or unused Clairette should be discarded safely and responsibly. Regulatory guidance instructs the return of the medicine to a local pharmacy or an authorized drug take-back program. It is strictly required that the medicine must not be thrown away via wastewater (such as flushing) or placed into standard household trash.

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

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