Утрожестан

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Утрожестан

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Утрожестан

Property Description
Active Ingredient Progesterone (Micronized)
Form Soft gelatin capsules
Pharmacological Class Progestogen, Steroid Hormone
Common Use Hormonal supplementation and support
Origin Natural (Body-Identical)

Утрожестан is a hormonal preparation utilized in gynecological and reproductive medicine contexts, designed to provide the essential steroid hormone, progesterone, to the body. Its pharmaceutical classification places it within the high-level group of progestogens, acting as a crucial component for hormone support therapy.


What Type of Medicine is Утрожестан?

Утрожестан is a single-component hormonal agent containing only the active ingredient progesterone (WHO International Nonproprietary Name). This substance is chemically classified as a steroid hormone and a pregnane derivative, functioning as a substitute for the progesterone naturally produced by the human corpus luteum. The medication is characterized as body-identical, meaning its molecular structure mirrors the hormone synthesized endogenously, a recognized classification for hormonal agents. This differentiates the preparation from non-identical synthetic progestins, underscoring its unique fit for specific hormonal supplementation needs.


The Origin and Composition of Утрожестан

The preparation contains natural micronized progesterone, indicating that the active compound is derived from a natural precursor and has been engineered into minute particles to ensure enhanced absorption. Micronization serves to significantly improve the bioavailability of poorly soluble compounds like progesterone. This processing step makes it easier for the body to absorb the hormone efficiently. The active substance is suspended within an oil base, typically a neutral vegetable oil, and is contained within soft gelatin capsules. The unique feature of this preparation is its capsule form, which allows for flexible options in therapeutic application.


The Core Physiological Purpose

The fundamental purpose of this medication is to provide necessary hormonal supplementation for women experiencing insufficient natural production. As the primary progestogen, its action focuses on facilitating the crucial endometrial transformation—the precise preparation and stability of the uterine lining. By ensuring this uterine environment remains intact and by contributing to uterine relaxation, the medication serves the general function of supporting the body's reproductive processes, particularly those linked to the maintenance of the luteal phase of the menstrual cycle.

Regulatory References

  1. Progesterone: MedlinePlus Drug Information

What side effects are possible with Утрожестан?

Possible side effects and safety information

The safety profile for micronized progesterone is based on official regulatory classifications, which organize documented adverse reactions by frequency and the body system affected. These classifications reflect the estimated rates of occurrence documented in authoritative governmental prescribing information.

Adverse Reactions and Frequencies

Classification Examples of Documented Effects
Common (ge 1/100 to <1/10) Headache, drowsiness, vomiting, diarrhoea, altered menstrual cycles, or intermenstrual bleeding.
Uncommon (ge 1/1,000 to <1/100) Cholestatic jaundice, skin reactions such as urticaria, or pruritus.
Frequency Not Known Anaphylactic reactions and chloasma (dark patches on the skin).

These effects involve several System-Organ Classes, including Nervous System Disorders (e.g., drowsiness), Gastrointestinal Disorders, and Skin and Subcutaneous Tissue Disorders.

Serious Safety Constraints

Regulatory documents list specific contraindications defining when the medicine must not be used. These include known severe hepatic failure or active liver disease, undiagnosed genital bleeding, active or recent thromboembolic disease (e.g., blood clots), and known, past, or suspected hormone-dependent malignant tumours (e.g., breast cancer). The medicine is also contraindicated in cases of known hypersensitivity to the active substance or certain excipients, such as soya lecithin.

Time and Population Safety Notes

Specific patterns are noted in official labeling. For the oral route, drowsiness and/or dizziness are primarily observed when the dose is administered during the day. The drug is generally not recommended during breastfeeding as the transfer into breast milk has not been sufficiently studied. Additionally, the label notes that progestins may potentially cause a reduction in glucose tolerance, requiring caution in specific patient groups.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents define the overdose profile for micronized progesterone based on the expected effects of high hormone exposure. The documented clinical manifestations observed in overdose scenarios primarily involve the Central Nervous System (CNS).

The most common signs of overdosage include drowsiness (somnolence), dizziness, and fatigue. Other symptoms reported in this context involve the gastrointestinal system, such as nausea and vomiting, as well as changes in mood, specifically depressive mood.


The official emergency response is immediate and definitive. Upon suspicion or confirmation of overdosage, the drug must be discontinued. Management is directed toward symptomatic and supportive treatment, as regulatory authorities state that no specific antidote is known for this compound.

Regulatory guidance requires patients to seek immediate medical attention or call emergency services if severe manifestations occur, such as collapse, seizure, trouble breathing, or inability to be awakened. Urgent medical assessment is also required for any suspected overdose scenario, regardless of the initial symptoms. Specific population considerations note that due to hepatic metabolism, the existing contraindication for severe liver dysfunction implies heightened risk in high-exposure cases.

Therapeutic Uses of Утрожестан

Утрожестан (micronized progesterone) is used in situations involving certain distressing symptoms where a systemic imbalance of natural progesterone may impact reproductive health and general well-being. This hormone is commonly used across key areas of women's health, where its core therapeutic role involves providing support when a deficiency is present.

The medication is relevant for easing symptoms that are part of conditions such as secondary amenorrhea, menstrual irregularities, and for providing luteal support during fertility treatments like IVF. It also may assist with managing symptoms associated with threatened miscarriage and is commonly used to help with reducing the chance of the uterine lining overgrowing during Hormone Replacement Therapy (HRT).

“The medication contributes to improved day-to-day comfort and may assist with maintaining a sense of emotional stability during symptomatic periods.”


Quick Fact: Relief for Cycle and Comfort Issues

Утрожестан is applied in addressing neurovegetative symptoms, such as insomnia and fluctuations in mood, while providing support for establishing a more predictable menstrual cycle pattern.

Regulatory References

  1. MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Утрожестан — Official Regulatory Information


Eligibility Scope

Populations for whom use is allowed (as stated in label): Adult women with an intact uterus; women undergoing Assisted Reproductive Technology (ART) cycles; women in the first trimester for luteal support. Populations for whom use is not recommended (if applicable): Lactating women (breastfeeding). Populations for whom use is contraindicated: Patients with Severe Hepatic Dysfunction; known or suspected Carcinoma (breast or genital tract); active or history of Thromboembolic Disorders (blood clots); Undiagnosed Vaginal Bleeding; or known allergy to soya or peanut. Age-related eligibility rules: Use is not established in the pediatric or geriatric populations. Condition-specific eligibility rules: Severe Hepatic Impairment is contraindicated. Patients with Renal Disease, Hypertension, or Diabetes Mellitus require close supervision. Pregnancy and lactation eligibility status (if explicitly documented): Allowed for specific first-trimester indications; Not Recommended during lactation. Eligibility-related restrictions: Requires close supervision in patients with a history of Migraine, Depression, Endometriosis, or Uterine Fibroids.


Eligibility Classifications (High-Level)

Eligibility severity classification (as defined in official documents): Absolute Contraindication; Restriction/Cautionary Use; Not Recommended; Use Not Established. Regulatory basis (EMA / FDA / etc.): Summary of Product Characteristics (SmPC) / Prescribing Information. Eligibility-context constraints (as defined in official documents): Eligibility is conditional on the absence of specific severe vascular, clotting, or liver pathologies.


Resulting Eligibility Structure

Official eligibility statements:

  • The medicine is contraindicated in patients with severe hepatic dysfunction or active thromboembolic disorders.
  • Use is not established in children, adolescents, or women over 65 years of age.
  • Use requires close supervision in patients with renal impairment, hypertension, or diabetes mellitus.

Connection to the overall eligibility profile (2–4 sentences): Official regulatory documents establish clear boundaries for the use of micronized progesterone by defining specific population exclusions, most notably severe liver pathology and vascular clotting risks. These classifications directly determine the regulatory permissibility for any individual to use the medicine under standard labeled conditions, while reserving use for specific circumstances in pregnant women.

What should I know about interactions with other medicines?

️ Interactions with other medicines and products

Utrogestan (micronized progesterone) is metabolized primarily by the liver, mainly through the cytochrome P450 (CYP450) enzyme system. Therefore, concurrent use with medicines that affect these enzymes can alter the concentration and effectiveness of progesterone in the body.


Medications that May Decrease Utrogestan Effectiveness

Drugs that act as CYP450 enzyme inducers accelerate the breakdown of progesterone, potentially leading to lower levels of the hormone and reduced therapeutic effect. Patients taking these drugs may require dosage adjustments or close monitoring by a healthcare provider. Examples of enzyme inducers include:

  • Certain Anticonvulsants/Epilepsy Drugs: Phenytoin, Phenobarbital, Carbamazepine.
  • Antibiotics/Antifungals: Rifampicin, Griseofulvin.
  • Herbal Products: St. John's wort (Hypericum perforatum).
  • Other: Phenylbutazone, Spironolactone.

Other Notable Interactions

  • Certain Antibiotics: Ampicillins and tetracyclines may alter the intestinal flora, which could affect the enterohepatic recycling of progesterone and thus its systemic levels.
  • Diabetes Medications: Progesterone may impair glucose tolerance, potentially increasing the required dose of insulin or other antidiabetic agents.
  • Ciclosporin: Progesterone may inhibit the metabolism of Ciclosporin, leading to increased plasma concentrations and potential toxicity of this immunosuppressant drug.

Always inform your doctor or pharmacist of all medications, over-the-counter products, and herbal supplements you are taking.

Mechanism of Action

Utrogestan (micronized progesterone) exerts its primary action by engaging key signaling pathways associated with reproductive and central nervous system functions. The principal mechanism is via activation of the intracellular nuclear Progesterone Receptor (PR), where the drug acts as an agonist. Upon binding, the progesterone-PR complex modulates gene transcription by binding to DNA, leading to the synthesis or repression of specific proteins. This genomic action initiates the decidualization and secretory phase of the endometrial lining.

Downstream consequences include the regulation of myometrial contractility through the downregulation of oxytocin receptor expression, which contributes to uterine quiescence. Concurrently, progesterone exerts rapid, non-genomic actions by functioning as a neurosteroid. This secondary mechanism involves allosteric modulation of ligand-gated ion channels, primarily the GABA A receptor, which results in decreased neuronal excitability and influences systemic regulatory feedback mechanisms.

Dosage and Administration Information

The administration of the micronized progesterone capsule is defined by established guidelines regarding its route, dose, and schedule.

Administration Routes and Scheduling

Two administration routes are typically utilized: Oral ingestion, which is used for systemic therapy like sequential Hormone Replacement Therapy (HRT), and Vaginal insertion, commonly employed for use in Assisted Reproductive Technology (ART) or when oral administration is not suitable.

Administration follows a cyclic or continuous pattern depending on the specific use protocol. For example, in sequential HRT, 200 mg is used once daily for 12 consecutive days per 28-day cycle. For luteal phase support, a higher daily dose, such as 600 mg, may be administered vaginally in divided intakes (e.g., three times per day) and is continued up to the 10th or 12th week of pregnancy.

Dosing and Conditions of Use

Standard daily dosing ranges from 200 mg to 400 mg for general use. The capsule is available in 100 mg and 200 mg strengths. For the oral route, the dose is taken at bedtime and away from food (e.g., two hours after eating). Capsules are swallowed whole with water; they should not be crushed or chewed. Regarding specific populations, use is generally restricted or not recommended in the presence of acute hepatic impairment. Patients adhere to the prescribed duration and not take a double dose if an intake is missed.

Recent Clinical Evidence

Утрожестан: Recent Clinical Evidence

Primary Research Areas

Clinical studies involving micronized progesterone (the active ingredient) primarily focus on its role in reproductive health. Key research areas include luteal phase support in Assisted Reproductive Technology (ART) cycles, the prevention of preterm birth, and the management of threatened or recurrent miscarriage.

Preterm Birth Prevention

Several randomized controlled trials (RCTs) have investigated the use of progesterone in pregnant women with specific risk factors for preterm delivery. In women with a singleton pregnancy and a short cervix (measured mid-trimester), the use of vaginal progesterone has been associated with a reduced risk of preterm birth. This effect has been consistently observed in women with a history of spontaneous preterm birth. Evidence of a similar benefit in women with multiple gestations is limited or absent.

Miscarriage Management

Research has explored the effect of progesterone in women experiencing unexplained threatened miscarriage (vaginal bleeding in early pregnancy). The largest trials suggest that while progesterone therapy did not universally increase the rate of live births, subgroup analysis indicated a possible benefit in women with a history of three or more previous miscarriages.

Assisted Reproductive Technology (ART)

Progesterone is widely studied and used for luteal phase support following embryo transfer in in-vitro fertilization (IVF) cycles. Studies confirm its role in preparing and maintaining the uterine lining (endometrium) to support embryo implantation and early pregnancy.

Frequently Asked Questions (FAQ)

Common questions about Утрожестан (FAQ)


Q: What is Утрожестан (Utrogestan) and how does it work?

Утрожестан (Utrogestan) is a medicine that contains the natural female hormone progesterone (micronized progesterone).

Progesterone is essential for preparing the lining of the uterus (endometrium) to accept a fertilized egg and for maintaining the environment needed for a healthy pregnancy. It also helps the lining of the uterus to shed during the menstrual cycle when pregnancy does not occur.

Утрожестан is used to supplement or replace the body's natural progesterone when it is deficient or needs support, often in the context of fertility treatments or preventing complications related to hormone imbalances.


Q: What is the main component of Утрожестан?

The main component of Утрожестан is micronized progesterone (a type of progesterone). The term "micronized" means the particles of the hormone have been reduced to a very small size to improve how well the body can absorb it.


Q: What is Утрожестан used for?

Утрожестан is used for conditions related to progesterone deficiency. These uses often include:

  • Support during Assisted Reproductive Technology (ART) procedures, such as In Vitro Fertilization (IVF), to prepare and maintain the uterine lining.
  • Preventing threatened or recurrent miscarriage in women with established progesterone deficiency or a history of recurrent pregnancy loss.
  • Treating menstrual disorders related to progesterone deficiency, such as irregular or painful periods.
  • Menopause as part of hormone replacement therapy (HRT) to protect the lining of the uterus from the effects of estrogen.

Q: How is Утрожестан administered?

Утрожестан is typically available as capsules that can be taken via two different routes:

  1. Orally (by mouth): Capsules are swallowed whole.
  2. Vaginally (inserted into the vagina): Capsules are inserted into the vagina, usually at night.

The route of administration depends on the condition being treated and the specific instructions from a healthcare provider. For instance, the vaginal route is often preferred in some fertility treatments as it delivers the hormone directly to the uterus with fewer side effects throughout the body.


Q: What are the common side effects of Утрожестан?

Common side effects can vary depending on whether the medication is taken orally or vaginally.

When taken orally, common side effects can include:

  • Drowsiness or dizziness
  • Fatigue
  • Headache
  • Breast tenderness
  • Changes in the menstrual cycle

When used vaginally, the common side effects are usually more localized and may include:

  • Vaginal discharge
  • Local irritation or itching

The vaginal route is generally associated with fewer systemic side effects (like drowsiness) because the hormone is absorbed more locally. Any concerning side effects should be discussed with a healthcare professional.


Q: Can I stop taking Утрожестан suddenly?

You should not stop taking Утрожестан suddenly unless specifically advised to do so by a healthcare provider. This is particularly important when the medication is being used to support an early pregnancy or as part of hormone replacement therapy.

If the medication is stopped abruptly, it can lead to a sudden decrease in progesterone levels, which may cause adverse effects such as breakthrough bleeding or an increased risk of miscarriage in early pregnancy. Your doctor will provide a schedule for safely discontinuing the medication when appropriate.

How should Утрожестан be stored and disposed of?

Storage and Disposal Requirements for Utrogestan/Prometrium (Progesterone)

Official labeling defines specific conditions for storing and disposing of progesterone capsules to maintain product integrity.

Required Storage Conditions

Condition Requirement
Temperature Range Store at Controlled Room Temperature: 20 C to 25 C (68 F to 77 F).
Prohibited Storage Do not refrigerate and do not freeze the capsules.
Protection Protect from excessive moisture and store in the original, light-resistant container.
Safety Keep the medicine out of the sight and reach of children.

Disposal Instructions

Unused or expired medicine must not be disposed of via household waste or flushed into wastewater. Disposal must be carried out strictly in accordance with local regulatory requirements for pharmaceutical waste.

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

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