Клайра

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Клайра

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Method of action: Contraceptive

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 Клайра

What is Клайра (Qlaira)?

Property Description
Active ingredient Dienogest, Estradiol Valerate (INN combination)
Form Film-coated tablets (Phasic/Dynamic-Dose)
Pharmacological class Combined Oral Contraceptive (COC) / Sex Hormone Combination
Common use Prevention of Pregnancy, Treatment of Heavy Menstrual Bleeding
Origin Synthetic Progestin; Natural Estrogen Prodrug

What Type of Medicine is Клайра (Qlaira)?

Клайра (Qlaira) is a Prescription-Only (Rx) Combined Oral Contraceptive (COC) that belongs to the pharmacological class of Sex Hormone Combinations. Its primary function is to provide highly effective contraception, and it is also clinically recognized for the treatment of heavy menstrual bleeding (menorrhagia) in women who desire oral contraception and who have no underlying organic pathology.

This medicine, manufactured by Bayer, is distinguished from many other COCs by its sequential, varying dynamic-dose (four-phasic) regimen. This structure is specifically designed to maintain stable hormone levels throughout the cycle.

Composition: Dienogest, Estradiol Valerate, and Unique Dosing

The active ingredients in Клайра are the progestin Dienogest and the estrogen component Estradiol Valerate. The estrogen component is particularly notable as it functions as a prodrug that the body metabolizes into 17beta-Estradiol, a compound identical to the natural estrogen produced by the female body. This contrasts with the synthetic estrogen found in many traditional COCs.

Dienogest is a specific synthetic progestin derivative. The unique dynamic-dose structure involves four distinct types of active film-coated tablets and two inactive pills, ensuring that hormone concentrations change across the 28-day cycle.

High-Level Function: The Principle of Hormonal Action

The core function of the medicine is to introduce hormones that signal the body to temporarily suspend the monthly process of ovulation, which is the release of an egg. This Hormonal Signal Suspension is the principal action for preventing pregnancy.

This combined hormonal action also provides protection by affecting the cervical secretion, causing the mucus to thicken and impede sperm movement, and by altering the uterine lining. This physiological action is clinically recognized for its dual benefit: reliable contraception and promoting predictable cycle control.

What side effects are possible with Клайра?

The safety profile of Клайра (Estradiol Valerate and Dienogest) is documented in official regulatory sources, which categorize potential adverse reactions based on frequency and affected system-organ class. All combined hormonal contraceptives carry a documented risk of serious adverse reactions, with the risk profile being managed through specific constraints and population-based statements.

Adverse Reaction Scope

Category Regulatory Documentation Notes
Most Frequent Reactions reported as Common (ge 2% in US trials) include headache (including migraine), breast pain/discomfort/tenderness, menstrual disorders, nausea, acne, mood changes, and increased weight.
System Classes Adverse effects are organized across systems, including Vascular, Nervous, Gastrointestinal, Hepatobiliary, and Reproductive System disorders.
Serious Adverse Reactions The most significant documented risk is Thromboembolic Events (VTE/ATE), which includes Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Stroke, and Myocardial Infarction. Rare cases of Liver Tumors (benign and malignant) are also documented.

Safety Considerations and Patterns

The risk of Venous Thromboembolism (VTE) is documented to be highest during the first year of use or when restarting the medicine after a break of four weeks or greater. Official labeling also includes specific population constraints. For instance, the medicine is contraindicated in women aged 35 years and older who smoke due to the substantially increased risk of serious cardiovascular events. It is also restricted for use in cases of severe liver disease or certain pre-existing thrombotic diseases.

The overall safety profile is structured to clearly define the rare, serious cardiovascular risks against the spectrum of common, non-life-threatening adverse reactions, ensuring all limitations and known time-related risk patterns are officially stated.

Overdose and Emergency Response

Overdose and when to seek help: Official Regulatory Information for Клайра

Overdose scope Category Official Regulatory Statement
Documented overdose presentations Nausea, vomiting, and, in young girls, slight vaginal bleeding.
Physiological systems affected (as stated in label) Gastrointestinal system (nausea, vomiting), Reproductive system (vaginal bleeding).
Dose-related or exposure-related factors (if applicable) Overdosage may cause nausea and vomiting, and withdrawal bleeding may occur in females.
Population-specific overdose notes (if applicable) Withdrawal bleeding may occur in young girls (pre-menarcheal).
Emergency-response statements (as written in official documents) There are no serious undesirable effects from overdosage, and no specific antidote is available. Treatment is symptomatic.
When immediate medical help is required (label-derived phrasing only) Not explicitly defined for typical overdose symptoms; medical care is symptomatic. Immediate medical attention should be sought for any signs of thromboembolism (e.g., severe chest pain, sudden breathlessness, swelling in one leg) or severe allergic reaction as these are serious warnings associated with combined oral contraceptives, regardless of overdose.

Overdose classifications (high-level) Category Official Regulatory Statement
Severity classification (as defined in official documents) No serious undesirable effects have been reported.
Regulatory basis (EMA / FDA / etc.) Derived from regulatory product information (e.g., EU SmPC, US FDA).
Overdose-context constraints (as defined in official documents) Based on general experience with combined oral contraceptives.

Resulting overdose structure Official overdose statements:

  • Overdosage may cause nausea and vomiting.
  • Withdrawal bleeding (slight vaginal bleeding) may occur, particularly in young girls.
  • No serious undesirable effects from overdosage have been reported.
  • No specific antidote is available for overdose.
  • Treatment for overdosage is symptomatic.

Connection to the overall overdose profile: Regulatory documents characterize the overdose profile of Клайра based on the known effects of combined oral contraceptives, indicating that symptoms are typically limited to non-serious, self-limiting effects such as nausea, vomiting, and withdrawal bleeding. The official guidance states that no serious ill effects have been reported and that management should be symptomatic, as no specific antidote exists. However, any development of signs suggestive of serious complications like a blood clot or severe allergic reaction warrants immediate medical attention, even if not directly listed as typical overdose sequelae.

Therapeutic Uses of Клайра

What Клайра Treats: Main Uses and Benefits

The primary therapeutic use of Клайра (Qlaira) is commonly used to help with the prevention of pregnancy for women of reproductive potential. It is applied across domains where additional symptomatic support is needed, primarily addressing two key clinical situations: fertility control and the treatment of heavy menstrual bleeding (menorrhagia) in women who desire oral contraception and who have no underlying organic pathology.


This combined hormonal approach is used for managing cycle predictability. Its therapeutic use supports a reduction in bleeding volume, which helps address the symptoms of excessive and prolonged blood loss. This support may assist in easing symptoms related to heavy blood flow and may contribute to easing systemic imbalance related to blood loss.

“The medication supports patients in maintaining a reliable rhythm for the menstrual experience, which is helpful in situations where symptoms of cycle variability interfere with daily comfort.”

Quick Fact: Therapeutic Use
Relevant for managing: Heavy and Prolonged Menstruation

This focus on symptomatic management may assist with maintaining functional stability and may help patients cope more steadily with episodes of heightened discomfort related to heavy periods.

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Клайра


The eligibility profile for Клайра is strictly defined by regulatory authorities and is based on high-risk medical conditions and population status. The medicine is approved for females of reproductive potential seeking contraception or treatment for heavy menstrual bleeding. However, use is formally contraindicated for several high-risk groups.

Absolute Exclusions and Contraindications

Contraindications include women with a high risk of arterial or venous thrombotic diseases, such as a history of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), or stroke. It is also prohibited for women over 35 years old who smoke, and those with known or suspected sex-steroid influenced malignancies (e.g., breast cancer), severe hepatic disease, or liver tumors. The medicine must not be used during pregnancy.

Conditional Use and Restrictions

  • Conditional Exclusion: The medicine is contraindicated in cases of uncontrolled hypertension or diabetes mellitus with vascular disease.
  • Surgical Restriction: Use must be stopped at least four weeks before and through two weeks after major surgery with prolonged immobilization.
  • Data Limitation: Efficacy has not been evaluated in women with a Body Mass Index (BMI) greater than 30 kg/m^2.
  • Age and Lactation: It is not indicated for post-menopausal women and is not recommended for nursing mothers.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Клайра (Dienogest/Estradiol Valerate) is defined primarily by interactions that alter the plasma concentrations of its hormonal components, a type of pharmacokinetic interaction. Co-administration with strong CYP3A4 enzyme inducers, such as the anti-infective Rifampicin or the herbal product St. John's wort, may significantly decrease the hormonal exposure, potentially reducing the medicine's effectiveness. Conversely, strong CYP3A4 inhibitors, such as the antifungal Ketoconazole, are documented to increase the exposure of both Dienogest and the active estrogen metabolite.

Interaction-Related Restrictions and Constraints

The label establishes mandatory restrictions for co-administration. Drug regimens containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, are contraindicated due to the documented risk of significant liver enzyme (ALT) elevations. For strong enzyme-inducing agents, an alternative non-hormonal contraceptive method must be used during and for at least 28 days following the discontinuation of the interacting medicine. Additionally, the hormonal components may influence the metabolism of co-administered drugs, documented to increase the plasma concentration of certain medicines like Theophylline.

Mechanism of Action

Клайра (estradiol valerate/dienogest) acts primarily through two complementary biological mechanisms. Its action involves modulating activity within the hormonal signaling pathways and modifying the reproductive tract environment.


Central Suppression of Ovulation

This mechanism focuses on the Hypothalamic-Pituitary-Ovarian (HPO) axis, the body's main hormonal control system. The exogenous hormones within Клайра exert negative feedback on the central control centers, suppressing the pituitary secretion of Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH). This targeted action inhibits the LH surge—the critical signal required for ovarian follicle maturation and the subsequent release of an ovum (ovulation).


Local Modulation of the Cervix and Endometrium

The second mechanism involves the direct influence of the progestin component, dienogest, on the peripheral reproductive tissues. It acts locally to alter the tissue environment, primarily by increasing the viscosity of the cervical mucus. This thickening creates a physical barrier that reduces sperm penetration through the cervix. Additionally, the hormonal action causes structural and functional changes in the endometrium (uterine lining) that modify its environment.

Dosage and Administration Information

How to Use Клайра: Administration Guidelines

Клайра is administered exclusively via the oral route as film-coated tablets, with the usage pattern defined by a continuous, 28-day sequential regimen. The standard adult dose for both approved indications is one tablet daily, which must be taken at approximately the same time every day.


Dosing and Cycle Structure

The dosage follows a dynamic-dose, four-phasic pattern containing 26 active hormone tablets and two inactive (placebo) tablets. The tablets must be swallowed whole and taken strictly in the order directed by the arrows or numbering on the blister pack, regardless of meals. This sequential order is mandatory for the regimen to function as intended.


Procedural Constraints

  • Daily Intake Constraint: The intake of any active tablet should not be skipped or delayed by more than 12 hours to maintain contraceptive effectiveness.
  • Continuous Use: The regimen requires continuous tablet-taking; a new 28-day pack must be started the day after the last tablet of the previous pack, with no pill-free break.
  • Initial Start: When initiating the regimen on the first day of the menstrual cycle, the protocol involves using a non-hormonal back-up method of contraception for the first nine consecutive days.
  • Population Note: The efficacy of the medicine for pregnancy prevention has not been evaluated in women with a Body Mass Index (BMI) of over 30 kg/m^2.

Recent Clinical Evidence

Клайра: Recent Clinical Evidence

Research has evaluated this drug, which contains estradiol valerate and dienogest, as a potential new option for patients seeking hormonal contraception and for the treatment of heavy menstrual bleeding (HMB).

Contraceptive Efficacy and Trial Scope

Clinical trials, including large-scale Phase 3 studies, assessed the drug's effectiveness in preventing pregnancy. The primary outcome measure in these trials involved recording the number of unintended pregnancies during treatment. Pooled analyses of study data documented a low Pearl Index, which is a key metric used to estimate contraceptive reliability. The results were examined across various age groups, supporting its use in women of reproductive age.

Findings on Heavy Menstrual Bleeding (HMB)

The combination has been specifically evaluated in randomized, double-blind, placebo-controlled Phase 3 trials for the management of HMB in women desiring oral contraception. These studies involved women with heavy blood loss over specified cycle periods.

Trial results documented significant differences in the measured menstrual blood loss volume among participants using the drug compared to those on placebo. Data also showed corresponding increases in blood markers like hemoglobin and serum ferritin in the active treatment group, suggesting a reduction in HMB-related iron depletion.

Bleeding Profile and User Satisfaction

Research has consistently focused on the bleeding patterns associated with the drug's unique multiphasic dosing regimen. Studies indicate an acceptable cycle control profile. Furthermore, real-world and comparative studies have explored user outcomes, documenting high rates of overall satisfaction and lower discontinuation rates related to bleeding issues compared to some other hormonal contraceptives.

Frequently Asked Questions (FAQ)

Common questions about Клайра (FAQ)

Q: Can women over the age of 35 safely use Клайра?

Official regulatory documents generally list the medicine as contraindicated for women 35 years of age or older who smoke. This constraint is due to a substantially increased risk of serious cardiovascular events in this specific group. Official documents do not list age alone as a reason to prohibit use.

Q: What are the general signs of a serious but rare side effect associated with Клайра?

Patient safety warnings, according to regulatory sources, highlight signs of serious blood clots (Thromboembolic Events). These signs can include sudden unexplained breathlessness, sharp chest pain, sudden severe headache, or sudden trouble speaking or walking. Pain or swelling in the leg is also a potential sign to be aware of.

Q: How does the body process the hormones in Клайра?

Клайра contains estradiol valerate, which the body processes as a prodrug and converts into 17beta-estradiol, a natural estrogen. The progestin component, dienogest, is metabolized with the involvement of a liver enzyme system known as CYP3A4. This process allows the body to absorb and use the active ingredients.

Q: Is it normal to have a very light period, or no period, while using Клайра?

Yes, official product information and clinical trial data indicate that a very light period or no periods (amenorrhoea) is a common reported side effect. Studies have also documented a significant reduction in menstrual blood loss volume for users of this medicine.

Q: Can certain anti-seizure medications interfere with the effectiveness of Клайра?

Official documents state that medicines that induce CYP3A4 enzymes may decrease the concentration of hormones in the blood, potentially reducing the medicine's effectiveness. This group often includes specific anti-epileptic or anti-seizure agents.

Q: Is there official information available on the long-term safety of using Клайра for many years?

Official documentation notes that the risk of blood clots (VTE) is highest during the first year of use or upon restarting after a four-week break. While risk patterns are documented to change over time, the regulatory text does not contain a specific statement summarizing safety after many years of continuous use.

Q: What should a user generally expect regarding their monthly cycle while taking Клайра?

The expected pattern is that withdrawal bleeding typically starts during the intake of the last active or inactive tablets of the pack. It is common for this bleeding not to be finished before the next 28-day pack is started. Experiencing no periods or irregular bleeding is also commonly reported.

Q: How is Клайра different from other combined oral contraceptives?

According to the official product description, the key differences relate to its composition and dosing structure. The medicine utilizes a dynamic-dose, four-phasic regimen, meaning the hormone levels vary across the cycle. Additionally, it contains the natural estrogen precursor estradiol valerate.

Q: How quickly does Клайра start to prevent pregnancy?

Official guidance on starting the medicine suggests that when switching from certain other methods or starting late, an additional barrier method of contraception is advised. This barrier method is advised for the first 9 consecutive days of taking the active pills.

Q: Do common antibiotics reduce the effectiveness of Клайра?

Regulatory text cites a potential risk of reduced effectiveness only with CYP3A4-inducing anti-infective agents, such as Rifampicin. Most common broad-spectrum antibiotics (such as those prescribed for minor infections) are typically not cited as a major risk in the official drug interaction documents.

Q: What happens if a non-active (white) pill is forgotten or missed?

If a non-active (white) tablet is missed, official instructions state that the tablet is advised to be discarded. Protection against pregnancy is not reduced by missing an inactive tablet, and the user is advised to simply continue taking the remaining tablets as scheduled.

Q: Is hair loss or hair thinning a reported side effect of Клайра?

Yes, official regulatory documentation lists hair thinning, or alopecia, as an uncommon side effect. Side effects are categorized based on how frequently they were reported in clinical studies.

Q: Does a history of migraines affect eligibility for using Клайра?

According to the official prescribing information, a history of migraine with aura is listed as a condition that contraindicates the use of this medicine.

Q: Does using Клайра affect cholesterol levels?

Official safety information for combined hormonal contraceptives includes warnings that these medicines may cause changes in serum lipid (cholesterol) levels. Changes in these levels are described as a general consideration when assessing combined hormonal contraceptives.

How should Клайра be stored and disposed of?

Official Storage and Disposal Requirements

Qlaira must be stored according to strict guidelines defined in regulatory labeling to maintain its efficacy and stability.

Requirement Official Regulatory Statement
Temperature Range Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F). Excursions are permitted between 15 C and 30 C.
Protection The medicine must be kept in the original blister pack and outer carton to protect it from light and moisture.
Child Safety The product must be stored out of the sight and reach of children.

Unused or expired Qlaira must be handled in compliance with official disposal protocols. The FDA recommends disposing of the product through an established drug take-back program as the preferred method. It is required that the medicine not be disposed of via wastewater (e.g., flushing down a toilet). If a take-back program is unavailable, the tablets should be mixed with an unappealing substance and sealed in a container before disposal in the household trash.

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

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