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Крайнон

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Крайнон

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Medically reviewed

Rosario Oropesa

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.

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Overview of Крайнон

What is Crinone Progesterone Gel?

Quick Facts Description
Active Ingredient Progesterone (INN)
Form Vaginal Gel (8%)
Pharmacological Class Gestagen / Progestogen
Common Use (General) Hormonal support and preparation of the uterine lining
Origin Bioidentical to Natural Hormone

Crinone Progesterone: What Type of Medicine Is It?

Crinone is a prescription medicinal product whose single active ingredient is Progesterone (INN). The drug is formally classified as a progestogen or gestagen, a category of steroid hormones that bind to the progesterone receptor in the body. This classification is clinically recognized for defining the substance’s role in modulating the female reproductive system. Progesterone is listed in the ATC system as a sex hormone and modulator of the genital system.

Crinone Composition: Is It a Natural or Synthetic Hormone?

The progesterone in Crinone is confirmed as bioidentical because its molecular structure is chemically and structurally identical to the natural hormone produced by the human corpus luteum. This structural match is a key differentiating factor from synthetic variants known as progestins. The Progesterone is delivered in the form of an 8% vaginal gel, using a specialized polymeric vehicle designed for intravaginal administration. This unique gel formulation provides a stable, targeted route for hormone delivery.

General Purpose of Crinone: Why Is Progesterone Needed?

The primary general purpose of Crinone is to offer essential hormonal support by compensating for a potential deficiency in the body’s endogenous Progesterone supply. Through its physiological action, the drug helps transform the inner lining of the uterus (endometrium) from its proliferative state into a secretory state. The primary therapeutic function of this substance is to prepare and maintain the lining of the uterus. This means the medication helps ensure a stable and receptive internal environment is established and sustained.

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What side effects are possible with Крайнон?

Possible Side Effects and Safety Information

The official safety profile for Crinone (Progesterone Gel) is classified based on frequency and affected body systems, as documented by government regulatory authorities.

Frequency-Classified Adverse Reactions

Adverse events are categorized by their observed likelihood during regulatory review:

  • Very Common (ge 1/10): Headache, somnolence (drowsiness), breast pain, nausea, and constipation.
  • Common (ge 1/100 to <1/10): Abdominal pain, vomiting, dizziness, breast tenderness, vaginal discharge, pruritus, and urticaria.
  • Frequency Not Known: Local reactions such as vaginal irritation/burning, intermenstrual bleeding (spotting), and gel accumulation may occur, alongside documented hypersensitivity reactions.

Systemic Safety Concerns

The most significant systemic safety concerns, though rare, are listed as potentially serious adverse reactions. These include thromboembolic events (such as Deep Vein Thrombosis, Pulmonary Embolism, and stroke) and certain ocular abnormalities (e.g., sudden partial or complete loss of vision). The product's Prescribing Information highlights these risks for careful monitoring.

Safety Restrictions and Limitations

Crinone is formally contraindicated and must not be used in specific clinical situations defined by regulatory bodies. These absolute restrictions include the presence of known or suspected severe hepatic impairment, known or suspected malignancy of the breast or genital organs, undiagnosed vaginal bleeding, active or historical thromboembolic disorders, and a known hypersensitivity to the product. Furthermore, the official label advises against the concomitant use of other local intravaginal preparations, as this may interfere with the intended progesterone absorption.

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Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Crinone Progesterone Gel states that an overdosage is not anticipated. This assessment is based on the product's unit-dose design, which uses an individual, disposable applicator, inherently limiting the opportunity for excessive acute exposure. Consequently, no specific symptoms or clinical manifestations of an overdose are formally documented in the regulatory labeling, and no known cases of an overdose have been reported.

If an overdosage is suspected, the primary action mandated by regulatory authorities is the immediate discontinuation of Crinone treatment. Management following discontinuation relies solely on symptomatic and supportive treatment, as the regulatory labels do not specify a pharmacological antidote.

The most critical instructions concern when to seek urgent medical help due to severe complications associated with the drug class. Individuals are explicitly required to seek emergency medical help immediately upon noticing signs of a severe allergic reaction, including hives, difficulty breathing, or swelling of the face, lips, or throat. Additionally, the drug must be discontinued immediately if the earliest manifestations of thrombotic disorders are suspected. These severe outcomes, such as symptoms of a blood clot in the lung (e.g., chest pain, rapid breathing) or a stroke (e.g., sudden weakness), are detailed in the official product information as conditions demanding immediate medical attention.

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Therapeutic Uses of Крайнон

What Крайнон Treats: Main Uses and Benefits

The medication is used to manage symptoms related to functional stability and symptoms that create noticeable physiological strain. The core therapeutic approach helps address acute and disruptive symptom patterns.

The primary therapeutic applications include providing supportive relief in situations involving certain distressing symptoms and managing manifestations associated with conditions characterized by periods of heightened symptoms. This assistance is commonly used when short-term symptomatic assistance is needed in clinical settings that involve acute or unstable symptom patterns. It helps address groups of symptoms that may become intense or disruptive, contributing to improved comfort during periods of heightened symptoms.

This approach supports patients during difficult episodes by easing distress. The product is relevant in conditions characterized by periods of heightened symptoms where functional stability is affected. The benefit is centered on easing the overall symptom burden and supporting functional stability when symptoms create noticeable strain.

“This medication is applied across domains where additional symptomatic support is needed, assisting with general well-being during symptomatic phases.”

Quick Fact: Supports Easing Symptom Intensity

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Eligibility and Restrictions for Use

Who can and cannot use Крайнон?

Regulatory authorities define strict population eligibility criteria for the use of Крайнон (Crinone Progesterone Gel).

Contraindicated Populations:

Use is strictly contraindicated (prohibited) in patients with specific conditions, including a history of active thromboembolic disorders (like deep vein thrombosis), known or suspected progesterone-dependent cancers (such as breast or genital malignancy), undiagnosed vaginal bleeding, a missed abortion, or known liver dysfunction or disease. Patients with a known hypersensitivity to progesterone are also ineligible.

Age and Physiological Restrictions:

The medicine is not recommended for the pediatric population (pre-pubertal children) as its use is not established. Similarly, use is not applicable or not established in the older adult (geriatric) population. During pregnancy, use is generally restricted to early pregnancy for specific indications (e.g., in ART) and is contraindicated in later stages. The product is not recommended during breastfeeding.

Conditional Use:

Use requires careful observation (conditional use) in patients with conditions that may be influenced by fluid retention, such as epilepsy, migraine, asthma, or cardiac/renal dysfunction. Patients with a history of depression also require close observation during use.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information regarding the use of Crinone with other medicines or products focuses primarily on the method of administration and potential for physical interference with absorption.

Category Official Regulatory Statement Constraint/Requirement
Medicinal Product Categories Other vaginal preparations or intravaginal means Not recommended/should be avoided concurrently
Mechanistic Basis Avoidance prevents impairment of the release and absorption of progesterone (pharmacokinetic interference) Physical separation is required
Systemic CYP Interactions While oral progestogens interact with CYP3A4 inducers, no significant consequences on progesterone levels is expected with the vaginal gel No dose adjustment or specific monitoring is advised due to CYP3A inducers
Timing-based Rules If other local intravaginal therapy is necessary, a six-hour period should separate its use from Crinone administration Mandatory time spacing if concurrent use is unavoidable
Other Interactions No incompatibilities were found with usual contraceptive devices No interaction constraint

The drug's interaction profile is uniquely defined by the constraint against concurrent intravaginal use due to the risk of affecting the release and absorption of progesterone from the gel. Regulatory labeling advises a mandatory time gap of at least six hours between Crinone and any other local intravaginal product. Furthermore, the official labeling notes that unlike with oral progesterone formulations, no significant effect on progesterone levels is expected when Crinone is used concurrently with CYP3A inducers.

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Mechanism of Action

How Крайнон Works: Mechanism of Action

Intracellular Progesterone Receptor Agonism

The active ingredient, progesterone, works by acting as an agonist (activator) of specific intracellular Progesterone Receptors (PR-A and PR-B) located primarily in the uterine lining (endometrium). This activation triggers the genomic signaling pathway, where the receptor complex regulates gene transcription to fundamentally change the cell's function.


Dual-Action Signaling for Endometrial Transformation

The mechanism involves both the slow, sustained genomic actions and rapid, non-genomic signaling cascades (via membrane receptors) to modulate cellular and tissue activity. This dual modulation drives the transformation of the estrogen-primed proliferative endometrium into a secretory endometrium (decidualization) and results in the establishment of a specialized endometrial lining.


Uterine Quiescence and Systemic Feedback Regulation

Beyond tissue differentiation, the mechanism also decreases uterine smooth muscle contractility (uterorelaxation) through non-genomic pathways. Systemically, progesterone also exerts negative feedback on the hypothalamic-pituitary-gonadal (HPG) axis, leading to the suppression of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) secretion.

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Dosage and Administration Information

How to Use Crinone Progesterone Gel

The administration of Crinone (Progesterone Vaginal Gel) adheres to specific, label-based instructions defining the route, dose, frequency, and duration of therapy as established by regulatory authorities.


Administration Scope

Instruction Detail
Route of Administration The medication is designed solely for intravaginal application using a single-use pre-filled applicator.
Dosing Schedule The standard regimen involves administering 90 mg of progesterone (the 8% concentration) once daily. In some protocols, the 90 mg dose may be prescribed twice daily.
Frequency and Timing Administration is a daily schedule, typically beginning at a defined point in the treatment cycle, such as the evening of oocyte retrieval or embryo transfer.
Course Duration The continuous daily administration is generally maintained for a limited course, often continuing for 10 to 12 weeks of gestation.
Missed Dose Rule If an application is missed, patients are generally instructed to resume the schedule with the next single dose on the following day; doubling the dose is not the stated procedure.

Procedural Context

Crinone is only available as a pre-filled gel formulation designed for direct, measured dosing; no dilution or preparation is required before use. The single-use applicator is intended to deposit a precise amount of gel into the vagina, and must be discarded after the dose is delivered. Instructions further specify that Crinone should not be used concurrently with other intravaginal products or devices, as this may compromise the absorption of the progesterone.

Population-specific rules are limited: the official label states there is no relevant use in pediatric or geriatric populations. These administration guidelines structure the precise and time-bound delivery of the medicine as authorized by regulatory bodies.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Крайнон

This overview explains the types of research and clinical studies that have been conducted for the vaginal progesterone gel, based on official regulatory sources and peer-reviewed scientific literature. It is strictly a summary of the evidence landscape and does not offer clinical advice or instruction.


Evidence for Use in Assisted Reproductive Technology (ART)

Research has explored outcomes in multiple Randomized Controlled Trials (RCTs). These studies were structured to compare Крайнон against other studied forms of progesterone delivery, such as intramuscular injections or different types of vaginal progesterone. These trials monitored key endpoints, including documenting the clinical pregnancy rate and the live birth rate.

Trial results reported that the clinical pregnancy and live birth rates observed in the gel group and the injection group showed comparable patterns. However, when comparing the gel to other vaginal progesterone formulations, the findings were mixed or variable across different systematic reviews. The research provides data related to group patterns measured in these treatment settings.


Evidence for Use in Secondary Amenorrhea

Research has also explored the use of Крайнон in women with secondary amenorrhea. The clinical trials were typically short-term, prospective studies that monitored outcomes related to the uterine lining following administration. Researchers primarily measured pharmacodynamic markers such as the documented morphological transformation of the endometrium and the subsequent observation of withdrawal bleeding. Findings reported that administration was associated with changes in the uterine lining, and that a measurable proportion of women experienced withdrawal bleeding following the treatment course.


Evidence Gaps and Areas of Uncertainty

The research landscape highlights several areas where certainty remains low. One key limitation is that for some uses, such as secondary amenorrhea, the primary endpoints are short-term physiological outcomes rather than long-term measures of functional health or quality of life. Long-term outcomes that extend far beyond the immediate post-delivery period are not well characterized in the existing studies. The evidence quality varies across studies, particularly when comparing the drug to different vaginal delivery systems, where findings were often mixed or showed only similar outcomes.

Key Studies & References World Health Organization (WHO) ATC/DDD Index: Progesterone (G03DA04) - Anatomical Therapeutic Chemical Classification System

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Frequently Asked Questions (FAQ)

Common questions about Крайнон (FAQ)


Q: Is Крайнон used only for purposes related to fertility treatments?

According to official product information, Крайнон is approved for more than just fertility treatments. While the 8% gel is indicated for progesterone supplementation in Assisted Reproductive Technology (ART), both the 4% and 8% concentrations are also approved for the treatment of a condition called secondary amenorrhea (the absence of a menstrual period).


Q: Are there any long-term effects noted in studies regarding the use of Крайнон?

Regulatory documents state that specific long-term outcomes extending far beyond the typical duration of use (10–12 weeks) are generally not fully characterized in clinical studies. The product information states that monitoring for potential serious, though rare, safety events like thromboembolic disorders (blood clots) is required.


Q: Can a person's mood or emotional state be affected by Крайнон?

Official product information indicates that emotional state can be affected by the drug. Depression and symptoms like feelings of severe sadness and unworthiness have been reported as potential side effects. The official label notes that close observation is required for patients with a history of depression during use.


Q: What is the difference between Крайнон and progesterone pills?

Крайнон is formulated as a vaginal gel, which is a key difference from progesterone taken as an oral capsule. By administering the medicine vaginally, the drug bypasses a process called first-pass metabolism in the liver. This difference results in a higher and more direct absorption of progesterone into the body compared to some oral forms.


Q: Why might a doctor prescribe Крайнон instead of a progesterone injection?

Regulatory-referenced clinical trials have compared the vaginal gel to intramuscular injections, reporting similar clinical pregnancy rates in ART treatment. This finding supports its use as an alternative delivery method to the injection.


Q: Is Крайнон considered a standard option compared to other progesterone delivery forms?

Studies and official information indicate that the vaginal gel is a standard option used in many ART protocols. Clinical research generally reports that the effectiveness of the gel in achieving clinical outcomes is comparable to the intramuscular injection and other forms of vaginal progesterone delivery.


Q: Does Крайнон absorb differently than other progesterone types?

Yes, Крайнон is designed to be absorbed differently than other types of progesterone. It is a bioadhesive gel, which means it adheres to the vaginal lining and provides a sustained and prolonged release of the hormone over time, avoiding the rapid systemic processing that occurs with oral medication.


Q: What are the general expectations for the first week of using Крайнон?

During the initial week of use, patients may experience some of the more common side effects documented in official safety information. These often include symptoms like headache, drowsiness, breast tenderness, and gastrointestinal effects like nausea or constipation. Local effects such as vaginal discharge or product accumulation are also common.


Q: Is there an officially recommended time of day for Крайнон application?

The official product information specifies that the treatment is administered on a daily schedule, which may be once or twice per day depending on the protocol. While administration is often timed relative to the specific fertility procedure (e.g., embryo transfer), the labels typically prioritize maintaining the consistent daily frequency over a mandatory specific time of day.


Q: Are there any common over-the-counter medicines known to interact with Крайнон?

Official drug interaction checkers list several common over-the-counter ingredients that have the potential for minor to moderate interaction with progesterone. These include items like aspirin, certain multivitamins, and melatonin. Official drug interaction information suggests caution and monitoring for concurrent use.


Q: What types of prescription drugs are known to potentially interact with Крайнон?

According to regulatory data, the progesterone in Крайнон has potential interactions with various classes of prescription drugs. These can include other estrogen replacement products, certain thyroid hormone medications, and even some other fertility treatments.


Q: Can men or non-pregnant women use Крайнон for any indication?

The approved therapeutic indications for Крайнон are limited to women of reproductive age. The drug is indicated for progesterone supplementation in infertile women undergoing ART and for the treatment of secondary amenorrhea (a condition affecting menstrual cycles).


Q: Why is Крайнон formulated as a vaginal gel?

Крайнон is formulated as a bioadhesive gel containing a specialized polymer called polycarbophil. This design allows the medicine to adhere to the vaginal lining, enabling a sustained and prolonged release of progesterone and ensuring a high, consistent level of absorption.


Q: What is meant by the 'progesterone effect' when discussing Крайнон?

The 'progesterone effect' refers to the hormone's core physiological action on the uterus. According to official documents and research, this effect causes essential structural changes in the endometrium (uterine lining) and is involved in establishing and maintaining a receptive internal environment.


Q: What inactive ingredients are listed in Крайнон's formulation?

Official drug documentation provides a complete list of the product's components. The inactive ingredients in the gel base include glycerin, light mineral oil, polycarbophil, carbomer homopolymer Type B, hydrogenated palm oil glyceride, sorbic acid, and purified water.


Q: Can Крайнон use be associated with weight changes?

Regulatory-associated information indicates that progesterone, as a class of drug, can be linked to weight gain. Weight changes may also be noted as a symptom associated with conditions requiring careful monitoring during treatment, such such as signs of depression.


Q: How quickly does Крайнон start to work after the first application?

According to pharmacokinetic studies, the progesterone is released continuously from the gel after application. Approximately 65% of the dose is released within the first 24 hours, and steady-state concentrations in the body are typically achieved by the end of that first day of treatment.


Q: How long does the effect of Крайнон last after a person stops treatment?

Due to the specialized bioadhesive gel formulation, the absorption of progesterone is sustained and prolonged. Official pharmacokinetic data shows the drug's absorption half-life is approximately 25 to 50 hours. The sustained-release properties of the gel mean the body absorbs progesterone over a prolonged period following the final application, consistent with its long half-life.


Q: Does Крайнон interact with common vitamins or nutritional supplements?

Official interaction checkers indicate potential interactions with certain common vitamins and nutritional supplements. Specific examples noted include melatonin and ingredients in prenatal multivitamins. These interactions are noted in official sources as requiring monitoring by the healthcare team.


Q: Are there any specific food items mentioned in official sources that interact with Крайнон?

Official interaction data mentions one specific food item that may interact with progesterone. Grapefruit juice is listed as having the potential to increase the levels of progesterone in the blood. Official information states that caution is required regarding its consumption due to this potential interaction.


Q: What is the maximum period of time Крайнон has been studied for continuous use?

For the approved indication of pregnancy support in ART, the continuous use of Крайнон is typically studied and approved for a maximum duration of 10 to 12 weeks of pregnancy.


Q: What regulatory bodies have officially approved Крайнон for marketing?

The official product information and safety documentation are maintained by several international government drug regulatory bodies. These include the US Food and Drug Administration (FDA), Health Canada, and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

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How should Крайнон be stored and disposed of?

How to Store and Dispose of Crinone

Crinone 8% (progesterone) vaginal gel must be stored according to specific regulatory requirements to maintain its stability.

Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, defined as 20°C to 25°C (68°F to 77°F).
Prohibitions Do not refrigerate and keep protected from heat.
Container Keep the product in the original container and store it out of the reach of children.

Disposal Instructions

Crinone is provided in single-use applicators; any unused portion of the gel must be discarded immediately after application. Used applicators and packaging should be disposed of in the trash, and they must not be flushed down the toilet. Disposal of any unused or expired medicine must comply strictly with local regulatory requirements.

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

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