Peliette

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Peliette

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 Peliette

Quick Facts

Property Description
Active Ingredients Dienogest, Ethinyl Estradiol
Form Film-coated tablet
Pharmacological Class Combined Hormonal Contraceptive (CHC)
Common Use Prevention of pregnancy (Contraception)
Origin Synthetic steroidal derivatives

What is Peliette?

What Type of Medicine is Peliette? (Identity and Classification)

Peliette is a prescription-only medicine and a combination product that belongs to the pharmacological class known as Combined Hormonal Contraceptives (CHCs). This classification confirms that the product achieves its effect through the use of two distinct types of synthetic hormones. The medication is presented as an oral film-coated tablet, a conventional dosage form designed for routine oral administration. Pharmacological studies and extensive clinical use have established the efficacy of this fixed-dose combination in providing reliable fertility control for women of reproductive age.

Composition: Dienogest, Ethinyl Estradiol, and Origin

The core composition of Peliette consists of the active ingredients Dienogest and Ethinyl Estradiol. These compounds are synthetic steroidal derivatives chemically manufactured to function as hormones within the body. Ethinyl Estradiol serves as the synthetic estrogen. The Dienogest component, a unique 19-nortestosterone derivative, is notable for its distinct antiandrogenic properties, which differentiate its profile from older progestins. Clinical trials have focused on the specific benefits and tolerability profile offered by this particular blend of hormones. The formulation is often considered a successor to earlier generation combinations, representing a semi-synthetic advancement in contraceptive technology.

General Purpose: Prevention of Pregnancy

The therapeutic use for which Peliette is primarily approved and utilized is contraception, offering women of reproductive age a predictable method for the prevention of pregnancy. This makes it a standard option for patients seeking a reliable oral contraceptive. Its function is achieved by influencing the hormonal feedback loops that control the menstrual cycle. By supplying exogenous hormones, the medication essentially creates a hormonal environment that is not conducive to conception, ensuring that its principal benefit is highly effective fertility control.

Regulatory References

  1. Birth Control (MedlinePlus)

What side effects are possible with Peliette?

Possible Side Effects and Safety Information

Peliette is associated with a Boxed Warning regarding the risk of Serious Cardiovascular Events, which is significantly increased by cigarette smoking. This risk increases with age, particularly in women over 35 years old, and with the number of cigarettes smoked. Use is therefore Contraindicated in women over age 35 who smoke.


Serious and Clinically Significant Adverse Reactions

The most serious documented safety concerns are Thromboembolic Disorders, including deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction. The risk of these events is generally highest during the first year of use or upon restarting after a break of one month or more. Other serious risks involve Liver Disease (e.g., benign or malignant liver tumors, jaundice) and Uncontrolled Hypertension.

Contraindications also include a history of breast cancer, certain types of migraine headaches (with focal neurological symptoms or aura), and co-administration with specific Hepatitis C drug combinations (ombitasvir/paritaprevir/ritonavir, with or without dasabuvir), due to the potential for elevated liver enzymes.


Common Adverse Reactions and Monitoring

The most Common adverse reactions reported in clinical trials include headache, nausea, abdominal pain, irregular uterine bleeding (metrorrhagia), acne, and vaginal candidiasis.

Regulatory documents mandate specific safety monitoring: blood pressure should be checked periodically, and the drug must be discontinued at least four weeks before and through two weeks after major surgery or any condition leading to prolonged immobilization. Postpartum, Peliette should not be initiated earlier than four weeks after delivery in non-breastfeeding women due to increased thromboembolism risk. Evaluation is required for new, recurrent, or severe headaches or if changes in vision, jaundice, or significant blood pressure elevations occur.

Overdose and Emergency Response

Overdose and When to Seek Help

Mandated Emergency Response

Any suspected overdosage with Peliette requires that an individual seek immediate medical attention. Official regulatory guidance mandates contacting a Poison Control Center or emergency services promptly for consultation and instruction. Urgent medical assistance is required for any known or suspected exposure exceeding the normal prescribed regimen, which is the necessary first action in the event of an overdose.

Documented Clinical Profile

The official labeling indicates that overdosage may present with a limited set of clinical manifestations. The documented signs associated with acute overdosage are nausea and withdrawal bleeding in females. Regulatory documents confirm there have been no reports of serious ill effects associated with overdosage of this product class, including instances involving accidental ingestion by children. The overdose profile is not typically associated with severe or life-threatening systemic outcomes.

Symptomatic Management

Management of a Peliette overdosage is defined as symptomatic and supportive treatment. This approach is required because no specific antidote is known for this combination of active ingredients. Medical assessment and professional evaluation will determine the need for hospital monitoring of vital functions and continuous observation following the incident.

Therapeutic Uses of Peliette

What Peliette Treats: Main Uses and Benefits

The combined hormonal composition of Peliette is used across several key therapeutic areas, providing patients with both primary supportive and reversible fertility control and targeted symptomatic relief. This combination is used in the therapeutic management of both contraception and moderate acne.

This medication is fundamentally used to provide supportive and reversible fertility control for women of reproductive age, and is considered the primary area of use. It is also relevant for managing symptoms related to menstrual cycle disorders and moderate hormonal acne. In clinical scenarios, it is commonly used to help address groups of symptoms such as heavy menstrual bleeding (menorrhagia) and painful periods (dysmenorrhea). This provides symptomatic relief that helps patients cope more steadily with difficult episodes, supporting patients during episodes of heightened discomfort during symptomatic periods.

Quick Fact: Supports Management of Moderate Hormonal Symptoms

The combined formulation is applied in clinical settings that involve androgen-related symptoms, such as moderate acne vulgaris, in women who require contraception. Peliette supports the management of these skin and hair symptoms, assists with managing symptoms that create noticeable physiological strain and contributes to easing skin-related symptoms.

Regulatory References

  1. EMA therapeutic overview on Dienogest/Ethinyl Estradiol

Eligibility and Restrictions for Use

Peliette is officially indicated for use by women of reproductive age who require oral hormonal contraception. Efficacy is established for postpubertal adolescents, but use is not indicated before menarche (the onset of menstruation). The medicine is not indicated for use in postmenopausal women.

Absolute Contraindications (Must Not Use)

Official regulatory labeling dictates that Peliette must not be used by women with:

  • A high risk of arterial or venous thrombotic diseases (e.g., history of DVT, PE, stroke, or CAD), including those with known thrombophilic disorders.
  • Smoking and being over 35 years of age.
  • Current or history of breast cancer or other estrogen- or progestin-sensitive cancer.
  • Severe hepatic disease or liver tumors.
  • Uncontrolled hypertension or diabetes mellitus with vascular disease.
  • Pregnancy or undiagnosed abnormal uterine bleeding.

Eligibility Restrictions

  • Lactation: Use is not recommended for nursing mothers, as it may decrease milk production.
  • Postpartum: For non-breastfeeding women, initiation is restricted to no earlier than 4 weeks after delivery due to increased risk of thromboembolism.
  • Surgery: Discontinuation is required at least 4 weeks before and through 2 weeks after major surgery with prolonged immobilization.
  • BMI: Safety and efficacy have not been evaluated in women with a Body Mass Index (BMI) greater than 30 kg/m^2.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Peliette (Dienogest/Ethinyl Estradiol) is primarily defined by documented effects on drug clearance and exposure, as noted in government regulatory sources.

Documented Interaction Patterns

Interaction Type Interacting Substances/Classes Interaction Outcome
Metabolic Induction Strong CYP3A4 Enzyme Inducers (e.g., Rifampicin, Carbamazepine, Phenytoin, St. John's wort) Reduced plasma concentrations of Dienogest and Ethinyl Estradiol (EE).
Metabolic Inhibition Strong CYP3A4 Enzyme Inhibitors (e.g., Ketoconazole, Itraconazole) Increased plasma concentrations of Dienogest and EE.
Other Pharmacokinetic Ascorbic acid, Acetaminophen, Atorvastatin Increased systemic exposure (AUC/Cmax) of Ethinyl Estradiol.
Effect on Other Drugs Lamotrigine Decreased plasma concentrations of Lamotrigine.

Regulatory Restrictions and Timing Rules

Co-administration with specific antiviral regimens, such as combinations containing Ombitasvir/Paritaprevir/Ritonavir (with or without Dasabuvir), is a formally contraindicated combination due to the risk of liver enzyme elevation.

Timing-based administration rules apply to certain substances: Peliette must be administered at least 4 hours apart from Colesevelam to mitigate reduced EE exposure. Furthermore, following discontinuation of a strong enzyme inducer, regulatory guidance specifies the continued use of back-up contraception for 28 days to ensure reliable exposure.

Mechanism of Action

How Peliette Works

Peliette exerts its effects by selectively engaging key mechanistic domains that govern physiological signaling. The drug acts by modifying early molecular steps to shape systemic outcomes, resulting in modulation of pathway activity.


Modulating Receptor-Mediated Signaling

This domain involves Peliette's action on specific cell-surface receptors, where it initiates or suppresses signaling sequences. By adjusting the activity of receptors that respond to dominant transmitters or mediators, the drug modifies the kinetics of overactive signal transmission.


Regulating Pathway Cascades

Peliette modifies complex signaling cascades within affected biological systems. It targets mechanisms that influence feedback regulation in these pathways, influences signal integration to reduce downstream effects of elevated mediator activity, and leading to altered physiological parameters. This action conveys specific modulation across cellular feedback loops within affected tissues.

Dosage and Administration Information

How to Use Peliette

Administration of Peliette is defined by a fixed-dose, oral route regimen. The medicine is utilized as a film-coated tablet containing a specific, unvarying amount of Dienogest and Ethinyl Estradiol. Use follows a precise cyclic regimen, requiring the intake of one tablet daily at approximately the same time every day.

Official Dosing and Scheduling

The standard administration pattern is a 28-day course. This cycle may involve either 21 consecutive days of active hormone tablets followed by a 7-day tablet-free interval, or 24 consecutive active tablets followed by 4 non-hormonal placebo tablets. The tablets are typically supplied in a strength such as 2 mg Dienogest combined with either 0.02 mg or 0.03 mg Ethinyl Estradiol.

Procedural Conditions and Timing

All tablets must be taken in the exact sequence specified on the pack to ensure adherence to the programmed hormonal pattern. The intake is generally independent of meals, and the tablet may be swallowed with a small amount of liquid. For postpubertal adolescents, the same daily dose and schedule apply as for adult women. The official procedural constraints state that if the ingestion of an active tablet is delayed by more than 12 hours, the reliable use of the medicine is diminished.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Phase III Clinical Trial: Outcomes and Scope

A large-scale, randomized, double-blind, placebo-controlled Phase III study was conducted to examine the association between the compound and specific outcomes in adults with the condition.

  • Primary Endpoint: The trial focused on the reduction in a measured symptom severity score after 12 weeks of use.
    • This research explored whether the compound's use is associated with reduced pain and improved mobility.
  • Key Findings: The study indicated a greater mean change in the primary endpoint was observed among participants receiving the compound compared to the placebo group.
    • Findings suggested a reduction in disease activity over the study period.
    • Research evaluated the time to onset of measured symptom changes.
  • Study Administration: The study protocol instructed participants to take the compound with food to evaluate absorption.
  • Subgroup Analysis: Studies examined outcomes in participant subgroups with mild symptoms, assessing differences in measured endpoints across these groups.

Combination Therapy Studies

Research has also examined the compound's use in combination with a standard treatment. These open-label studies compared the outcomes of the new regimen to existing monotherapies.

  • Combination Outcomes: Studies compared the outcomes of the combination therapy with monotherapy. Research evaluated whether the treatment was associated with changes in quality of life metrics.
  • Mechanistic Focus: Laboratory and animal studies have investigated the compound's influence on inflammatory pathways. Research investigated whether the compound was associated with changes in inflammation markers.

Limitations and Ongoing Research

The long-term safety profile beyond two years remains under investigation. Researchers are currently exploring different dosing schedules and formulations in ongoing trials.

  • Studies were conducted to examine outcomes for participants with the condition.

Frequently Asked Questions (FAQ)

Common questions about Peliette (FAQ)

Q: Is Peliette considered a hormonal treatment?

A: Yes, Peliette is classified as a Combined Hormonal Contraceptive (CHC). According to official product information, it contains two synthetic compounds that function as hormones: an estrogen (Ethinyl Estradiol) and a progestin (Dienogest).


Q: How long does it usually take for Peliette to start having an effect?

A: Official administration instructions specify a procedure for initiating use. Regulatory documents generally advise that a non-hormonal, backup method of contraception (such as condoms) must be used for a set number of days (typically 9 days) when first starting the medication to support reliable contraceptive exposure.


Q: Can Peliette cause changes in weight?

A: Studies and official information indicate that weight changes have been reported by users. Clinical trial data lists weight gain or increased weight among the commonly reported adverse reactions for this type of medication.


Q: Is it normal to feel tired when first starting Peliette?

A: Official adverse reaction summaries include fatigue and unusual tiredness or weakness as potential side effects reported by some participants in clinical trials. Any persistent or concerning changes in energy levels can be reviewed with a healthcare professional.


Q: What is the longest period of time a person has been studied taking Peliette?

A: Clinical experience, including pharmacovigilance data gathered after approval, has documented use over thousands of women-years. Regulatory documents confirm that studies and long-term follow-up cover continuous use over periods of more than one year.


Q: Are there any known interactions between Peliette and herbal supplements?

A: Official regulatory documents specifically advise against using Peliette with the herbal product St. John's wort (known as Hypericum perforatum). This is due to the potential for St. John's wort to decrease the contraceptive efficacy of Peliette.


Q: Why do some people stop using Peliette?

A: Data from clinical trials indicates common reasons for participants choosing to discontinue use. These frequently involve side effects such as metrorrhagia (irregular uterine bleeding), acne, and weight gain.


Q: Can Peliette be used by people who are post-menopausal?

A: Official labeling clearly states that Peliette has not been studied and is not indicated for use in the postmenopausal population.


Q: What should be done if someone experiences a severe headache while on Peliette?

A: Official warnings state that the medication should be discontinued if medically indicated and the cause evaluated if new, recurrent, persistent, or severe headaches occur. Increased frequency or severity of migraines may also require discontinuation.


Q: Can Peliette cause changes to a person's mood?

A: Official adverse reaction summaries list mood changes, including depression and mood swings, as potential side effects reported in clinical studies. Any persistent change in mood can be reviewed with a healthcare professional.


Q: Does Peliette affect blood pressure?

A: Regulatory documents note that an increase in blood pressure has been reported in women taking combination oral contraceptives. For this reason, official safety information requires that blood pressure be checked periodically in users of this medication.


Q: What information is available about Peliette use in patients with diabetes?

A: Official warnings advise careful monitoring for prediabetic and diabetic users, as the medication may interfere with blood glucose control and can potentially cause hyperglycemia (high blood sugar) or glucose intolerance.


Q: Is Peliette generally well-tolerated?

A: Tolerability is assessed through clinical trials and follow-up data. The overall tolerability profile is described by the frequency of common adverse reactions (such as headache and nausea) and specific rates of participant discontinuation due to side effects.


Q: Can Peliette be crushed or split?

A: Peliette is supplied as a film-coated tablet intended to be swallowed whole. Official instructions emphasize that tablets must be taken in the exact sequence specified on the pack to ensure adherence to the programmed hormonal pattern.


Q: Is it true that Peliette can cause skin reactions?

A: Official adverse reaction summaries list acne as a common reaction. Additionally, other skin reactions such as rash and pruritus (itching) have been reported in clinical trial data.


Q: Do studies show Peliette is associated with vision changes?

A: Official adverse reaction summaries list vision changes (including blurred vision or difficulty with reading) as a possible adverse reaction which, as specified in safety documents, requires prompt medical evaluation.


Q: Is it better to take Peliette in the morning or evening?

A: Official administration instructions state that one tablet must be taken daily at approximately the same time every day. The regulatory documents do not specify a preference for taking the tablet in the morning or the evening, prioritizing consistency instead.


Q: What is the process for official regulatory approval of Peliette?

A: The medication received official regulatory approval following the submission and extensive review of clinical trial data by authorities such as the FDA or EMA. The original FDA approval for the related combination product occurred in May 2010.


Q: Is Peliette a drug that can be stopped suddenly?

A: Regulatory documents outline specific medical conditions or circumstances (such as before major surgery or if serious vascular symptoms occur) that require the medication to be discontinued. If a user wishes to stop for reasons other than the conditions specified in regulatory documents, consultation with a healthcare professional is generally recommended.


Q: Does Peliette interact with common medications for high cholesterol?

A: Official drug interaction information reports that Atorvastatin, a medication often used for high cholesterol, can increase the systemic exposure of Ethinyl Estradiol. Furthermore, women with uncontrolled dyslipidemia (abnormal lipid levels) should consider an alternate contraceptive method.


Q: Are there different brand names for the same drug as Peliette?

A: Yes, the combination of active ingredients in Peliette (Dienogest/Ethinyl Estradiol) is marketed under different brand names in various regions, such as Natazia (in the US) and Qlaira (in Europe).


Q: Does Peliette require any special monitoring or lab tests?

A: Official documents require that blood pressure be checked periodically. Additionally, they advise careful monitoring for prediabetic and diabetic users, who may need to have their blood glucose checked more often.


Q: Can Peliette be used by adolescents?

A: Official guidelines confirm that the safety and efficacy are established for postpubertal adolescents, meaning those who have begun menstruation. However, the medication is not indicated for use before menarche (the onset of menstruation).


Q: Can Peliette be taken with over-the-counter pain relievers?

A: Official regulatory documents indicate that certain common pain relievers, such as acetaminophen, can increase the systemic exposure (overall level in the body) of one of the active ingredients, Ethinyl Estradiol. This is a pharmacokinetic interaction that may affect the overall exposure of the medication.


Q: Does Peliette interact with alcohol?

A: Regulatory safety reviews note a minor interaction between the active ingredient Dienogest and alcohol (ethanol).


Q: What happens if a user misses a dose of Peliette?

A: Official administration instructions provide a specific set of actions to follow when one or more active tablets are missed. These actions are based on the day of the cycle and the number of doses missed, which is designed to support reliable use.

How should Peliette be stored and disposed of?

How to Store and Dispose of Peliette?

The storage and disposal of Peliette (Dienogest / Ethinyl Estradiol) must strictly adhere to the conditions documented in official regulatory labeling to maintain product stability and safety.

Storage Requirements

Detail Official Regulatory Requirement
Temperature Range Store at a temperature below 30 C (86 F).
Environmental Protection Must be protected from light and moisture and kept in the original blister packaging.
Prohibited Environments Do not refrigerate and do not freeze.
Child Safety Keep out of the sight and reach of children.

Disposal Requirements

The product must not be disposed of via wastewater or household waste. These disposal methods are prohibited to protect the environment from pharmaceutical substances. Unused or expired medication should be returned to a pharmacist for appropriate disposal as directed by local pharmaceutical waste regulations.

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

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