Levosert

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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.

Overview of Levosert

Property Description
Active ingredient Levonorgestrel
Form Intrauterine Delivery System (IUS)
Pharmacological class Progestogen-only contraceptive
Common use Long-term reversible contraception
Origin Synthetic steroid hormone

What Type of Contraceptive is Levosert?

Levosert is defined as an Intrauterine Delivery System (IUS), a specialized, small, flexible, T-shaped device inserted into the uterus by a healthcare professional. As a method characterized by immediate reversibility and long duration, it is formally categorized as a Long-Acting Reversible Contraceptive (LARC). The product belongs to the high-level pharmacological class of progestogen-only contraceptives, containing the active substance, Levonorgestrel, which is released directly into the local uterine environment. Levonorgestrel-releasing systems are associated with health benefits comparable to other hormonal methods by reducing the risk of benign gynecological conditions.

Levosert: Composition and Chemical Origin

The core component of Levosert is the active ingredient, Levonorgestrel, a compound that is chemically classified as a synthetic progestin. Levonorgestrel is a steroid hormone that is manufactured to mimic the biological activity of natural progesterone. The hormone is embedded within an elastomeric core or polymer matrix that encircles the vertical stem of the T-shaped frame, enabling the device to function as a controlled-release system. This unique design constitutes a differentiating factor compared to systemic hormonal administration, as it provides localized drug delivery.

What is the General Purpose of Levosert?

The central function of Levosert is the effective, long-term prevention of pregnancy via localized drug delivery. The continuous, low-dose release of Levonorgestrel works by causing the uterine lining (endometrium) to thin and by significantly thickening the mucus in the cervix, thereby creating a physical barrier to sperm. This device is clinically recognized for both contraception and the treatment of heavy menstrual bleeding. Consequently, the device is expected to provide highly reliable contraception alongside a significant therapeutic advantage in managing excessive menstrual blood loss.

What side effects are possible with Levosert?

The official safety profile for the levonorgestrel intrauterine system (Levosert) is defined by government regulatory documents which classify adverse reactions by frequency and physiological system.

Adverse Reaction Classifications

Adverse effects are categorized based on their documented frequency in clinical use:

  • Very Common (ge 1/10 users) events primarily involve changes to menstrual bleeding patterns (e.g., spotting, oligomenorrhea, amenorrhea), along with procedural pain, procedural bleeding, and vaginal infections.
  • Common (ge 1/100 to < 1/10 users) effects include headache, depressive mood, dizziness, abdominal pain, nausea, acne, breast tenderness, pelvic pain, and device expulsion.
  • Uncommon (ge 1/1,000 to < 1/100 users) events include Pelvic Inflammatory Disease (PID) and skin disorders like alopecia.

Serious Adverse Reactions and Safety Constraints

The regulatory label documents low-incidence, but clinically significant risks. These include uterine perforation (most often occurring during insertion), ectopic pregnancy (which should be considered if any pregnancy occurs), and reports of severe infection or sepsis following insertion.

Specific population-related safety considerations are noted, including an increased risk of perforation for women who are postpartum or lactating. Furthermore, regulatory information states that the device does not protect against HIV or other sexually transmitted infections, and the effectiveness may be reduced when certain enzyme-inducing medicines are used concurrently. These classifications and notes structure the understanding of the medicine’s official risk profile.

Overdose and Emergency Response

The regulatory documentation concerning Levosert overdose primarily addresses situations involving acute systemic exposure to high doses of the active ingredient, Levonorgestrel. Because Levosert is an Intrauterine Delivery System (IUS) that provides localized, low-level release, a true systemic overdose from the device in place is considered highly improbable. The established official profile is based on the ingestion of high doses of the active substance.

Documented Manifestations and Severity

Official regulatory documentation states that serious undesirable effects have not been reported following the acute ingestion of large doses of Levonorgestrel, indicating a non-severe classification. Documented clinical manifestations that may occur are typically limited to mild, transient events such as nausea and the occurrence of withdrawal bleeding. This information applies to the systemic effects of the progestogen.

Emergency Actions and Management

In the event of a suspected overdose, official instructions mandate specific emergency action: it is required to get medical help or to contact a Poison Control center right away. This instruction must be followed regardless of the documented non-severe nature of the reported symptoms. The required management approach is strictly symptomatic in nature, as regulatory documents explicitly confirm that no specific antidote is known for Levonorgestrel overdose. No unique monitoring requirements or population-specific considerations are documented in the official labeling.

Therapeutic Uses of Levosert

What Levosert Treats: Main Uses and Benefits


The levonorgestrel intrauterine system (IUS), including Levosert, is commonly used to help with two key therapeutic domains. Its indications include providing effective, long-acting contraception and the management of excessive menstrual blood loss (HMB).

Effective, Long-Term Pregnancy Prevention

Levosert is used to provide effective, long-acting contraception, addressing the continuous risk of unwanted conception over an extended duration. This domain is relevant for individuals seeking an intervention that provides sustained protection. It generally supports long-term reproductive planning and may assist with maintaining a sense of stability when symptoms are more noticeable.

Management of Excessive Menstrual Blood Loss (HMB)


The device is applied in conditions characterized by the symptom of excessive uterine bleeding (menorrhagia), a clinical manifestation that can lead to daily functional strain. It is commonly used for patients with chronic heavy periods who require supportive management to moderate this distressing symptom. It generally contributes to easing the overall symptom load by addressing the volume of monthly blood flow, and helps with managing symptoms that interfere with daily comfort and supports general well-being during symptomatic phases.

Quick Fact: Therapeutic Domains
Levosert is used across domains where additional symptomatic support is needed, primarily addressing the continuous risk of conception and the symptomatic burden of heavy bleeding.

Eligibility and Restrictions for Use

Levosert is approved for use in females of reproductive age, but official regulatory labeling defines several categories of use, including absolute prohibitions and specific restrictions based on age and clinical history.

Contraindicated Populations (Must Not Use)

Use is strictly prohibited if a patient has or is suspected of having a pregnancy. The system is also contraindicated in cases of current or recurrent pelvic inflammatory disease (PID), undetermined abnormal uterine bleeding, and in the presence of uterine or cervical malignancy. Patients with a history of breast cancer or other hormone-sensitive cancer, or those with acute or severe liver disease (including tumors), are also excluded from use, as stated in the prescribing information.

Age and Physiological Restrictions

Population Group Regulatory Status Constraint
Pediatric Use Not recommended Use is not indicated before the onset of menstruation (menarche).
Geriatric Use Not indicated The system is not intended for use in postmenopausal women.
Lactating Females Permitted Breastfeeding can be continued, as a risk to the infant is not expected.
Postpartum Insertion Restricted Should be postponed until the uterus is fully involuted, generally not earlier than six weeks after delivery, due to an increased risk of uterine perforation.

Additionally, caution is advised, and removal may be necessary, if certain conditions develop, such as new-onset severe migraine, jaundice, or severe arterial disease.

What should I know about interactions with other medicines?

Levosert is an intrauterine delivery system (IUS) that releases the hormone levonorgestrel directly into the uterus. Because its action is primarily local and the amount of levonorgestrel absorbed into the bloodstream is very low, the risk of clinically significant drug interactions is considered low compared to oral contraceptives. However, it is essential to be aware of certain medicinal products that have the potential to affect hormone levels.

Potential Effect of Enzyme-Inducing Medicines

The primary concern for interactions involves medicines that are known to induce, or increase the activity of, hepatic (liver) microsomal enzymes, particularly the Cytochrome P450 (CYP) enzyme system.

  • Mechanism: These enzyme-inducing substances may speed up the metabolism and clearance of levonorgestrel from the body, potentially leading to reduced levels of the hormone in the blood. While the IUS works mainly through local effects within the uterus, reduced systemic exposure could, in theory, compromise its overall effectiveness.

Categories of Interacting Medicines

Although the risk is small, tell your healthcare provider if you are taking any medicines from the following classes, as they may be enzyme-inducers:

  • Medicines for Epilepsy: e.g., Phenytoin, Phenobarbital, Carbamazepine, Primidone.
  • Medicines for Infections: e.g., Rifampicin, Rifabutin (used for tuberculosis and other infections), Griseofulvin (an antifungal).
  • HIV Treatments: e.g., Nevirapine, Efavirenz.
  • Herbal Products: St John’s Wort (Hypericum perforatum).

If you are taking any of these substances, your doctor may recommend closer monitoring. Levosert should not be used in combination with another hormonal contraceptive method. Studies indicate that unlike oral hormonal methods, the efficacy of the levonorgestrel IUS is generally not expected to be affected by these enzyme-inducing medications due to its localized action.

Mechanism of Action

The action of Levosert is defined by the continuous, targeted delivery of Levonorgestrel, a synthetic progestin, which engages multiple local mechanisms within the reproductive tract. Its primary mechanism begins as Progesterone Receptor ( PR) agonism in the uterine lining (endometrium). This molecular interaction initiates a continuous anti-proliferative cascade, causing the endometrium to undergo significant thinning and atrophy. This tissue modification results in a structurally non-receptive uterine environment. Simultaneously, Levonorgestrel modulates the secretory function of the cervical epithelium. This action generates a profound increase in the viscosity and cellularity of the cervical mucus, forming a dense, physical plug that mechanically impedes the progression of sperm into the upper genital tract. A supplementary mechanism involves altering the local intrauterine fluid composition, which inhibits sperm motility and survival. These three independent, local actions—endometrial modification, physical barrier formation, and sperm function inhibition—constitute the drug's full physiological effect.

Dosage and Administration Information

Official Administration Guidelines: How Levosert is Used

Levosert is an Intrauterine Delivery System (IUS) containing 52 mg of levonorgestrel. The official instructions for its use are governed by its method of administration and continuous dosing structure.


Administration Scope

Entity Instruction
Route of Administration Intrauterine delivery; the device is inserted directly into the uterine cavity.
Dosing Schedule Provides a continuous, low-dose release of levonorgestrel, starting at approximately 20 micrograms (mu g) per 24 hours. This rate gradually declines over time.
Age-Group Rules The system is not indicated for use before menarche (first menstrual bleeding).
Special Procedural Conditions Insertion must be carried out by a trained healthcare professional using strict aseptic technique. The IUS is supplied in a sterile pack for single use only.

Course Duration and Timing

Levosert is intended for long-term use, but it must be removed or replaced based on the specific duration licensed for its indication:

  • Contraception: Licensed for continuous use for up to 8 years.
  • Heavy Menstrual Bleeding (HMB): Licensed for demonstration of efficacy for up to 3 years or 5 years, depending on the regional regulatory authority.

The IUS may be inserted at any time if pregnancy is reasonably excluded, or typically within the first seven days of the menstrual cycle.


The administration protocol establishes Levosert as a specialized, long-acting form of drug delivery that requires a single, professional insertion. The continuous release of the hormone dictates that there are no daily user steps or missed-dose rules; the official use pattern is defined solely by its fixed duration.

Recent Clinical Evidence

Contraceptive Efficacy and Duration

Clinical trials have established the efficacy and long-term use of the 52 mg levonorgestrel-releasing intrauterine system (LNG-IUS), including Levosert, for contraception. Recent findings support the use of this device for up to eight years to prevent pregnancy. A major multicenter study, which tracked participants for up to eight years, reported consistently high contraceptive efficacy throughout the extended duration of use.

Treatment for Heavy Menstrual Bleeding (HMB)

Research has explored the use of the LNG-IUS for managing heavy menstrual bleeding (HMB). Studies indicate a substantial reduction in menstrual blood loss for most users with HMB. For many, this reduction exceeds 90% by six months of use. This reduction in blood loss is often associated with improvements in measures of quality of life, such as daily functioning and pain/cramping, particularly in cohorts with heavy menstrual bleeding.

Clinical data to support the duration of effectiveness for the HMB indication are typically cited up to three to five years.

Outcome Type Key Clinical Findings
HMB Reduction Significant decrease in menstrual blood loss observed in trials.
Contraception High effectiveness reported for up to eight years of continuous use.

Safety and Tolerability

Overall, the 52 mg LNG-IUS has demonstrated a safety profile consistent with the known class of intrauterine systems. In long-term studies, the device was generally well tolerated. The most common adverse events reported in extended use trials include vulvovaginal infections and vaginal bacterial infections. The rate of device-related complications, such as expulsion and ectopic pregnancy, remained low across the follow-up period.

Frequently Asked Questions (FAQ)

Common questions about Levosert (FAQ)

Q: How quickly does Levosert start working after it is put in?

According to official contraception guidance, if the device is inserted within the first five days of your menstrual cycle, it provides immediate protection against pregnancy. If the insertion happens outside of this specific window, it is generally recommended to use a reliable backup method, such as condoms, for the following seven days for reliable protection.

Q: Can Levosert be used for heavy periods even if I don't need birth control?

Yes, Levosert is officially licensed for treating heavy menstrual bleeding (HMB), in addition to its primary use as a contraceptive. Because the device continuously releases the hormone levonorgestrel into the uterus, it is designed to provide effective contraception alongside the HMB treatment.

Q: Is it typical for menstrual cramps to change after Levosert insertion?

Changes in menstrual patterns, including cramping, are a typical expectation. While some users report common side effects such as pelvic pain, many find that their periods become less painful or stop completely over time. Persistent severe pain is a symptom that may warrant evaluation by a healthcare professional.

Q: Can taking common painkillers affect how Levosert works?

Official product information emphasizes interactions with certain enzyme-inducing medicines, which could theoretically affect the systemic hormone levels. There are no general regulatory warnings that common, non-enzyme-inducing over-the-counter painkillers, such as ibuprofen or paracetamol, affect the effectiveness of Levosert.

Q: Are there any long-term health concerns mentioned in official documents regarding Levosert?

Levosert is approved for long-term use, lasting up to eight years for contraception. The main long-term risks documented in official safety information include the low risk of uterine perforation (most often at insertion) and ectopic pregnancy, though the overall risk of pregnancy is very low. Studies indicate the device is generally well-tolerated over its approved duration of use.

Q: What is the likelihood of expulsion for Levosert in the first year?

The risk of the device being displaced or expelled (moving out of the uterus) is generally considered low. Clinical studies indicate this risk is highest in the first year of use, particularly within the first three months after the system is inserted, with estimates around 1 in 20 users.

Q: Are there warnings about using Levosert with specific heart conditions?

Caution is advised if certain serious conditions develop, such as severe arterial disease. Official information states that smoking increases the risk of developing blood clots, stroke, or heart attack with hormonal products, and prescribers typically advise women who smoke to discontinue use.

Q: Is it possible to feel the Levosert device once it is placed?

The T-shaped device itself is not expected to be felt inside the body. However, the fine threads attached to the IUS hang slightly out of the cervix and can be felt with a clean finger. Feeling these threads is a method for checking that the device is still in the correct position.

Q: Are there any specific activities, like swimming or exercise, that should be avoided with Levosert?

Once the device is settled, there are generally no restrictions on activities such as swimming or exercise. It is typically only recommended to avoid inserting anything into the vagina (like tampons or menstrual cups) for the first two weeks immediately following the fitting procedure.

Q: What happens if Levosert is removed earlier than its official duration?

The contraceptive effect of Levosert stops immediately upon its removal. The removal procedure is quick, and patients may experience mild cramping and light spotting for a few days afterward.

Q: Does using Levosert affect future fertility after it is taken out?

No. Official information indicates that fertility is expected to return quickly after the IUS is removed, regardless of how long it was used. Many women in studies achieved pregnancy within a few months of having the device taken out.

Q: What is the connection between Levosert and ovarian cysts?

The hormone in Levosert may occasionally lead to the development of small, fluid-filled sacs, known as ovarian cysts. These cysts are typically harmless, frequently resolve on their own, and often do not cause symptoms.

Q: Does the removal process of Levosert usually involve pain?

The removal procedure is generally quick and is associated with minimal discomfort. Mild cramping is commonly reported either during or shortly after the device is withdrawn by the healthcare professional.

Q: What does official information say about the return of the menstrual cycle after Levosert removal?

After the removal of the IUS, the release of the hormone stops immediately. If your menstrual periods became lighter or stopped while using the device, the return to your previous menstrual cycle pattern may take a few weeks, or up to three months, to stabilise.

Q: Is it necessary to use any backup method after Levosert insertion?

If insertion occurs outside the first five days of your menstrual cycle, it is generally recommended to use a reliable barrier method of contraception, such as condoms, for the following seven days.

Q: Is a follow-up visit after insertion mandatory for Levosert users?

While the manufacturer's patient information advises users to regularly self-check the threads, it is standard clinical practice to schedule a follow-up appointment. This is typically done around six weeks after insertion to allow a healthcare professional to confirm that the device is correctly positioned.

Q: What is described in product literature as the purpose of the threads on Levosert?

The threads serve two main functions, according to the patient information. They allow the user to check that the device is still in place, and they are used by the healthcare professional to easily and safely remove the IUS when required.

Q: Can a person get an MRI scan with Levosert in place?

Yes, patients with Levosert in place can generally undergo MRI procedures. The device belongs to a class of levonorgestrel-releasing intrauterine systems made of non-metallic materials, which are deemed compatible with patients undergoing MRI procedures at all static magnetic field strengths.

Q: Does Levosert affect sexual desire or libido?

Changes to sexual desire, or libido, are a reported possibility with progestogen-only contraceptives. However, official information often indicates that there is not enough direct clinical evidence to confirm whether these changes are definitively caused by the device.

Q: Is it possible to use menstrual cups or tampons with Levosert?

It is generally recommended to use sanitary pads immediately after insertion. If using tampons or menstrual cups, official guidance recommends avoiding them for the first two weeks after fitting. Patients are generally advised to exercise caution when using menstrual cups, due to the risk of suction potentially dislodging the IUS.

Q: How do doctors check if Levosert is still in the correct position?

The position of the IUS is checked by physical examination, which includes confirming the presence of the threads. If the threads are not visible or if the device's position is suspected to have changed, a doctor may use an abdominal ultrasound scan or sometimes an X-ray to confirm the exact location of the system.

Q: Why is it important to check for the threads regularly?

Checking the threads allows you to confirm that the device has not slipped or been partially or completely expelled. If the device is out of place, its effectiveness in preventing pregnancy may be reduced, and contacting a healthcare provider for evaluation is generally recommended.

How should Levosert be stored and disposed of?

How to Store and Dispose of Levosert?

Levosert is supplied in a sterile pack and must be protected from light and moisture until it is ready for use. Official regulatory documents specify the following requirements for storage and disposal:

Storage Component Requirement
Temperature Does not require any special temperature storage conditions (or store below 30 C)
Light/Moisture Store in the original package and keep the sealed tray in the outer carton to protect from light and moisture
Sterility/Handling Supplied in a sterile pack; do not open until required for insertion. For single use only. Do not use after the expiry date.
Child Safety Keep this medicine out of the sight and reach of children

For disposal, if the sterile package seal is broken, the unused system (including the inserter) must be discarded. Likewise, a Levosert system once removed from the patient must be disposed of as biohazardous waste according to local guidelines. The outer carton and inner pouch packaging can be handled as household waste, but the product itself may pose a risk to the environment.

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

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