Lutinus

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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 Lutinus

Quick Facts

Property Description
Active ingredient Progesterone
Form Vaginal tablet (Pharmaceutical preparation)
Pharmacological class Progestogen, Steroid hormone
General purpose Hormonal support, Endometrial preparation
Origin Bio-identical steroid hormone

Identity, Classification, and Form

Lutinus is a specific, single-ingredient pharmaceutical preparation classified as a progestogen, which belongs to the larger class of steroid hormones. It is exclusively supplied as a vaginal tablet, a distinct dosage form designed for localized administration. The formulation is a prescription-only medicine whose specific micronization process is intended to optimize absorption. This identity means Lutinus is categorized as an exogenous hormone intended to provide essential hormonal support, often differentiating it from generic or non-vaginal delivery forms.

Composition and Origin: Lutinus as a Progesterone Derivative

The active ingredient in Lutinus is Progesterone, a naturally occurring steroid hormone that is chemically defined as Pregn-4-ene-3,20-dione. The medicine is a Progesterone derivative and is considered a bio-identical hormone because its molecular structure is identical to the Progesterone synthesized endogenously. As a single-ingredient product, its composition includes micronized Progesterone combined with the necessary tablet excipients (solid vehicle). This bio-identical structure is pharmacodynamically distinct from synthetic progestins.

General Purpose: What is the Role of this Hormone?

The fundamental role of Lutinus is to provide targeted hormonal support within the reproductive system. The active ingredient functions by directly binding to and activating progesterone receptors (PRs). This physiological action is crucial for endometrial transformation, a process that involves preparing the inner lining of the womb (endometrium), helping it to thicken and become stable. By replenishing the natural hormone, Lutinus aids in the fundamental biological processes that require specific hormonal regulation in women of reproductive age.

Regulatory References

  1. National Library of Medicine (NIH) on Progesterone Administration

What side effects are possible with Lutinus?

Possible Side Effects and Safety Information

The safety profile of Lutinus is organized by regulatory documents based on the likelihood of adverse reactions and the physiological system affected. The data defines specific conditions and patient groups requiring particular caution or for which the medicine is strictly prohibited.

Frequency-Classified Adverse Reactions

The most frequently documented effects, classified as Common (affecting ge 1/100 to < 1/10 patients), include headache, abdominal distension, nausea, abdominal pain, and uterine cramping/spasm. Effects documented as Uncommon include dizziness, insomnia, diarrhoea, constipation, various vulvovaginal disorders (such as discharge and discomfort), skin rash/urticaria, and peripheral oedema. Reactions reported through post-marketing experience are categorized as Frequency Not Known, and include fatigue and hypersensitivity reactions.

Serious Safety Signals and Restrictions

Official labeling contains warnings regarding thromboembolic events, including arterial and venous thromboembolism and cerebrovascular disorders. Use of the medicine is strictly contraindicated in individuals with a history of these events, as well as in those with severe hepatic dysfunction or known or suspected breast or genital tract cancer.

Patients with conditions susceptible to fluid retention, such as epilepsy, asthma, or cardiac/renal dysfunction, require careful observation. The label notes that the abrupt cessation of dosing may be associated with effects such as increased anxiety and moodiness.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information for Lutinus (progesterone vaginal tablet) outlines the manifestations and management of overdose based strictly on clinical documentation.


Documented Overdose Manifestations

High doses of progesterone may be associated with symptoms documented in official regulatory labeling. These effects generally reflect a low toxicity profile.

System Documented Manifestation
Central Nervous System Drowsiness, Somnolence, Dizziness, Euphoria
Reproductive System Dysmenorrhoea (Painful menstruation)

No specific severe or life-threatening outcomes are formally documented within the overdose sections of the regulatory prescribing information reviewed for this product class.


Official Emergency Actions and Management

Regulatory authorities mandate specific actions for managing suspected overdose:

  • Initial Action: The primary mandated step is the discontinuation of Lutinus.
  • Treatment Principle: Management consists of the institution of appropriate symptomatic and supportive care.
  • Antidote: No specific antidote is described in the official labeling.

When to Seek Medical Help: Urgent medical attention is required for the institution of appropriate supportive care if symptoms occur or persist following the discontinuation of the medicine. The official guidance does not mandate specialized monitoring requirements for this non-severe overdose profile.

Therapeutic Uses of Lutinus

Lutinus (progesterone) vaginal tablets are primarily used in the reproductive health domain and are applied across domains where additional symptomatic support is needed. The medication is prescribed to women undergoing fertility treatment.

The main therapeutic domain is relevant for easing symptoms related to systemic imbalance, specifically in conditions where functional stability becomes affected. This medicine is commonly used to help with symptoms associated with acute or episodic changes that create noticeable physiological strain. Its primary use includes luteal support during an Assisted Reproductive Technology (ART) treatment program for infertile women.

The core benefit is that the treatment assists with maintaining functional stability and contributes to easing the overall symptom load. Lutinus may be part of symptomatic management in clinical settings that involve acute or unstable symptom patterns. One patient-oriented benefit is that the medication supports general well-being during symptomatic phases.

“The product provides supportive relief when symptoms interfere with routine activities.”

Quick Fact: Supports symptoms related to systemic imbalance

Regulatory References

  1. Health Products Regulatory Authority (HPRA) package leaflet

Eligibility and Restrictions for Use

Who can and cannot use Lutinus?

Lutinus is an exogenous progesterone formulation whose use is strictly defined by regulatory authorities. The medicine is indicated for adult women of reproductive age who are undergoing an Assisted Reproductive Technology (ART) treatment program for infertility.

The use of Lutinus is contraindicated and must be avoided in patients with a history of or active arterial or venous thromboembolism, severe hepatic dysfunction or disease, and known or suspected breast or genital tract cancer. It is also prohibited for use in cases of undiagnosed vaginal bleeding, known missed abortion, ectopic pregnancy, or Porphyria disorders.

Eligibility during pregnancy is confined to the first trimester and is otherwise prohibited. The medicine should not be used by breast-feeding women. Furthermore, use requires careful observation in patients with conditions such as mild to moderate hepatic dysfunction, renal or cardiac dysfunction, diabetes, epilepsy, or migraine. Regulatory documents state there is no relevant use in the paediatric population and no clinical data collected for patients over 65 years of age.

What should I know about interactions with other medicines?

The interaction profile for Lutinus is primarily defined by the pharmacokinetic handling of the active ingredient, progesterone, and constraints related to its vaginal administration. Progesterone is metabolized via the hepatic enzyme system CYP3A4, making its systemic exposure susceptible to modulation by other substances.

Co-administration with medicines that induce the CYP3A4 enzyme, such as the antibiotic Rifampicin or the anticonvulsant Carbamazepine, may increase the elimination rate of progesterone. This documented pharmacokinetic effect results in a decrease in the systemic bioavailability of the active ingredient. The herbal product St. John’s Wort (Hypericum perforatum), a known CYP3A4 inducer, is also listed as potentially increasing progesterone elimination.

Conversely, medicines that inhibit the CYP3A4 enzyme, specifically Ketoconazole, may decrease the elimination rate, which can lead to an increase in the systemic exposure of progesterone.

A critical restriction tied to the drug's local delivery is co-administration with other vaginal products, such as antifungal creams or lubricants. Regulatory documents state that the concomitant use of these products is not recommended, as it may alter the physical release and absorption of the progesterone from the vaginal tablet. No medicinal product is formally classified as a contraindicated combination due to interaction risk.

Mechanism of Action

Progesterone Receptor Engagement

Lutinus is an exogenous formulation of the steroid hormone progesterone, and its mechanism of action is mediated primarily by binding with high affinity to the intracellular Progesterone Receptor (PR). This binding and the subsequent translocation of the activated receptor-ligand complex to the cell nucleus constitute the central mechanistic domain. The complex functions as a ligand-activated transcription factor, leading to the modulation of gene expression in target tissues such as the endometrium. This action controls cellular proliferation and differentiation, thereby influencing the maintenance of hormone-sensitive cells.


Central Regulatory Modulation

Within the central nervous system (CNS), progesterone engages a regulatory mechanism influencing the hypothalamic-pituitary-ovarian (HPO) axis. This mechanistic cascade involves the inhibition of Gonadotropin-Releasing Hormone (GnRH) secretion from the hypothalamus. The resulting pathway effect is a reduction in the release of pituitary gonadotropins, specifically Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH), which facilitates the inhibitory feedback regulation of the HPO axis.


Neurotransmitter System Interaction

The drug's metabolite, allopregnanolone, provides an additional level of pharmacodynamic action through non-genomic effects in the brain. This neuro-modulatory mechanism involves the direct interaction with specific GABA-A receptors, a crucial component of the inhibitory neurotransmitter system. The pathway effect is an allosteric enhancement of GABAergic inhibition, which contributes to the overall suppression of neuronal excitability within the CNS.

Dosage and Administration Information

Lutinus is administered exclusively via the vaginal route as a 100 mg tablet, utilizing the applicator provided with the medicine to facilitate proper placement. The standard adult dosing regimen is 100 mg per dose, taken three times daily (TID), resulting in a total daily dose of 300 mg of progesterone.

Official Usage Protocol

Treatment initiation begins on the day of oocyte retrieval as part of an Assisted Reproductive Technology (ART) program. The regimen is designated to be continued for 30 days following the start of treatment, specifically if pregnancy has been confirmed. The treatment should not be stopped abruptly and any cessation must be determined by a healthcare professional.

Procedural guidance is provided for situations where the timing is missed: the user is instructed to administer the dose as soon as remembered, or to skip it if it is nearly time for the next scheduled dose, with a directive not to take a double dose to compensate.

Population-Specific Use

Clinical data is unavailable for use in older women (over age 65) or the pediatric population, and there is no experience with use in patients who have impaired liver or kidney function. These usage principles are established for the medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Lutinus

This section provides an overview of the types of research and clinical evaluations for Lutinus (progesterone vaginal tablets), focusing only on the structure of the evidence used by regulators. This is a summary of research and does not include information on dosing, safety, or clinical recommendations.


Evidence for Use in Assisted Reproductive Technology (ART)

Lutinus was studied for use as Luteal Phase Support (LPS) applied in research contexts involving women undergoing fertility treatments, specifically in vitro fertilization (IVF) that involves the transfer of fresh embryos. The core research was conducted during periods of increased symptom activity relevant in trials assessing short-term symptom patterns following ovarian stimulation.

The main body of evidence includes Randomized Controlled Trials (RCTs). Research explored how the Lutinus formulation performed in non-inferiority studies compared to an established vaginal progesterone product. The evidence is also supported by systematic reviews and meta-analyses, which are research methods that pool the findings of multiple related studies to provide a broader view of the evidence landscape for progesterone in ART.

Evaluating the Clinical Trial Design and Study Outcomes

In the pivotal research, the focus was on major outcomes related to systemic or functional imbalance. Researchers primarily monitored endpoints such as the Live Birth Rate (LBR) and the Ongoing Pregnancy Rate. Studies monitored how outcomes related to the Ongoing Pregnancy Rate evolved, reporting that measurements fell within the predefined non-inferiority range when compared to the reference progesterone treatment. This research provides context but does not determine whether an individual will respond similarly.

A key regulatory trial was observed in a design where assessors were blinded to the product received. However, that trial was open-label, meaning that the participants and doctors involved were generally aware of which progesterone product was evaluated in the study.

Gaps in the Research and Areas of Uncertainty

Data for certain groups remain insufficient. Most of the available high-level evidence focuses on fresh embryo transfer protocols. There is limited information for the use of this specific formulation in contemporary frozen embryo transfer (FET) protocols, particularly those using modified natural cycles. The follow-up durations were limited to the short-term outcomes described above, as long-term effects are not fully established by the existing pivotal studies.

Key Studies & References

  1. Lutinus 100 mg vaginal tablets - HPRA Authorised Product Information

Frequently Asked Questions (FAQ)

Common questions about Lutinus (FAQ)


Q: What is Lutinus prescribed for, generally?

A: Official documents clearly state that Lutinus is indicated exclusively for luteal support as part of an Assisted Reproductive Technology (ART) treatment program for infertile women. It is not approved or intended for other general uses.


Q: Is Lutinus used for conditions other than fertility treatment?

A: According to the official therapeutic indications listed by regulatory bodies, Lutinus is indicated exclusively for luteal support in women undergoing an Assisted Reproductive Technology (ART) program. It has no other formally approved indications.


Q: What is the role of progesterone when a person is not pregnant?

A: The fundamental role of progesterone, the active ingredient in Lutinus, is to provide targeted hormonal support within the reproductive system. Its primary function is to promote endometrial transformation, which is the process of preparing the inner lining of the womb for a potential pregnancy, a key process during the luteal phase of the cycle.


Q: Why is Lutinus sometimes prescribed after ovulation induction?

A: Lutinus is formally indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment program. Ovulation induction is often the initial stage of the ART process, which is then followed by the need for progesterone support (luteal support) after egg retrieval.


Q: How quickly should Lutinus start working after I begin using it?

A: Studies on the drug's activity show that maximum levels of progesterone in the blood typically occur between 8 and 12 hours after the first dose. According to the official product information, consistent, steady-state levels of the hormone are generally reached within about one day after starting treatment.


Q: Is it normal to experience light bleeding or spotting while using Lutinus?

A: Yes, some light bleeding or spotting is a possibility. Clinical trial data indicates that vaginal bleeding is a documented adverse reaction, although it is considered common, affecting between 1 and 10 in every 100 patients. Undiagnosed bleeding, however, is listed as a contraindication for using the medicine.


Q: Is it normal to have breast tenderness while using Lutinus?

A: Official documents for progesterone products note that breast tenderness and other breast discomforts may be an expected adverse reaction associated with the use of progesterone.


Q: Can Lutinus cause gastrointestinal issues like nausea or stomach cramps?

A: Yes, regulatory documents list several gastrointestinal issues as common side effects of Lutinus, meaning they occur in 1 to 10 out of every 100 patients. These commonly reported effects include nausea, abdominal pain, abdominal distension (bloating), and uterine cramps.


Q: Can using Lutinus cause changes in mood or make me feel irritable?

A: Yes, changes in mood are a recognized effect. Official product information lists irritability and mood swings as expected adverse reactions associated with progesterone use. Additionally, patients with a history of depression are advised to be closely monitored during treatment.


Q: How is the feeling of dizziness or drowsiness associated with Lutinus described in official documents?

A: Official product information notes that the medicine has a minor to moderate influence on the ability to drive or operate machinery. This is because Lutinus may cause drowsiness and/or dizziness (Dizziness is listed as an uncommon side effect).


Q: Can Lutinus cause weight changes or fluid retention?

A: Official warnings note that progesterone may cause some degree of fluid retention in the body, which is also described in the safety profile as peripheral oedema (swelling). For patients with conditions that are susceptible to being worsened by fluid retention, such as certain cardiac or kidney issues, careful observation is required.


Q: Does Lutinus affect cholesterol or blood sugar levels?

A: While Lutinus is primarily a progesterone product, official precautions note that similar hormone therapies have shown decreased glucose tolerance and changes in insulin sensitivity. Consequently, careful observation throughout the course of treatment is required for patients with diabetes. The official documents do not directly state an effect on cholesterol.


Q: Can people with a history of depression use Lutinus?

A: Official regulatory warnings state that patients with a history of depression need to be closely observed during treatment. If symptoms of depression worsen, discontinuation of the medicine may be considered by a healthcare professional.


Q: Is it possible to be allergic to an ingredient in Lutinus?

A: Official regulatory documents state that use of Lutinus is strictly contraindicated (must be avoided) in any individual with a known hypersensitivity (allergic reaction) to the active substance, progesterone, or to any of the non-active ingredients listed in the tablet’s composition.


Q: Are there any common interactions with antibiotics or antifungal medications?

A: The antibiotic Rifampicin and the antifungal Ketoconazole are specifically noted in interaction warnings as they can affect progesterone levels in the body. Furthermore, official documentation advises against using other vaginal products—which may include certain antifungal creams—at the same time as Lutinus, as this could interfere with absorption.


Q: Does Lutinus interact with vitamin supplements or herbal products?

A: Regulatory documents state that certain herbal products may influence how the body handles the medicine. Specifically, products containing St. John’s Wort (Hypericum perforatum) are known to potentially decrease the medicine's overall effectiveness. Discussing all supplements and herbal products with a healthcare professional is advised.


Q: Can Lutinus affect the results of other medical lab tests?

A: Official safety warnings indicate that a decrease in glucose tolerance (the body's ability to process sugar) has been observed in some patients using similar hormone-based therapies. For this reason, careful observation throughout the course of treatment is required for patients with diabetes. Progesterone may also affect results of tests that rely on hormone levels.


Q: Does Lutinus contain any ingredients derived from animals or plants?

A: The active ingredient, progesterone, is a bio-identical steroid hormone. Regulatory composition documents list the presence of an excipient known as lactose monohydrate, which is a substance derived from milk.


Q: What does the FDA or other regulatory bodies say about the efficacy of Lutinus?

A: Efficacy was established through a core clinical trial that focused on key outcomes like the Ongoing Pregnancy Rate and Live Birth Rate. These studies reported that the medication's performance fell within the predefined non-inferiority range when compared to a reference progesterone treatment.


Q: How is the research evidence for Lutinus described in medical literature?

A: The main evidence used for regulatory approval includes Randomized Controlled Trials (RCTs). These studies primarily focused on establishing non-inferiority compared to other progesterone treatments, with primary endpoints including the Live Birth Rate in women undergoing fresh embryo transfer protocols.

How should Lutinus be stored and disposed of?

How to Store and Dispose of Lutinus

Storage Requirements

Lutinus vaginal tablets do not require any special temperature storage conditions according to official regulatory labeling. The medication must be stored in the original container to protect from light.

The product has an official shelf life of 3 years when stored correctly and must not be used past the expiry date stated on the carton.

Safety and Handling

For safety, this medicine must be kept out of the sight and reach of children.

Disposal Instructions

Official instructions state that Lutinus must not be thrown away via wastewater or household waste to protect the environment. Users are directed to ask the pharmacist how to throw away medicines no longer needed.

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

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