Endometrin

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Medically reviewed

Laura Arias

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 Endometrin

Quick Facts

Property Description
Active ingredient Progesterone (Micronized)
Form Vaginal Insert (Lyophilized Tablet)
Pharmacological class Progestational Agent (Progestogen)
General purpose Luteal Phase Support (LPS)
Origin Bio-identical Steroid Hormone

What Type of Medicine Is Endometrin?

Endometrin is a specialized prescription medication classified as a progestational agent (progestogen), belonging to the steroid hormone class. Its core function is to supplement the female body's natural supply of the hormone Progesterone. The active ingredient is micronized Progesterone, a substance that is chemically bio-identical to the naturally occurring steroid hormone produced by the body, distinguishing it from certain synthetic progestins. This distinction is clinically recognized for providing a critical hormone necessary for maintaining a stable reproductive environment.

Endometrin Composition and Delivery Form

The active component, micronized Progesterone, is delivered via a solid-dose vaginal insert, which is a type of lyophilized tablet. This unique dosage form and the corresponding intravaginal route of administration are key differentiating features. The insert contains the progesterone within a compact matrix that dissolves locally, enabling direct and consistent absorption into the circulation supplying the uterus. The vaginal route allows for high local uterine concentrations, which means the therapeutic effects are effectively concentrated where they are needed most.

General Purpose and Role in Treatment

The primary general purpose of Endometrin is to provide crucial Luteal Phase Support (LPS). This essential role is centralized on preparing and sustaining the uterine environment. The medication works by inducing and maintaining the necessary secretory changes in the uterine lining (endometrium), transforming it into a state that is receptive to an implanted embryo. By consistently supplementing progesterone levels, the drug offers the critical hormonal backing required for patients undergoing procedures such as Assisted Reproductive Technology (ART).

Regulatory References

  1. NIH Drug Information on Progesterone

What side effects are possible with Endometrin?

Endometrin: Possible Side Effects and Safety Information

Adverse reactions associated with Endometrin are classified by official regulatory bodies based on their frequency of occurrence and the physiological system affected.

Frequency-Classified Adverse Reactions

The following are examples of adverse reactions listed in official prescribing information:

  • Very Common (Affects more than 1 in 10 users): Headache, Abdominal distension (bloating), Nausea, Fatigue (or somnolence/drowsiness), and Breast tenderness or pain.
  • Common (Affects 1 to 10 users in 100): Dizziness, Mood changes or depression, Gastrointestinal discomfort, and Vaginal discharge or local irritation.

These effects are generally grouped by System-Organ-Classes (SOC), including the Gastrointestinal Disorders, Nervous System Disorders, and Reproductive System & Breast Disorders.

Serious Adverse Reactions and Safety Restrictions

Regulatory documents emphasize specific safety concerns. Serious adverse reactions documented for progestins include thromboembolic events, such as deep vein thrombosis (DVT), pulmonary embolism (PE), and cerebral vascular thrombosis. Potential signs associated with this risk, such as sudden vision loss, are also noted.

Safety Restrictions and Contraindications: The use of Endometrin is strictly contraindicated in individuals with certain pre-existing conditions. These restrictions include severe liver dysfunction or disease, a current or past history of thromboembolic disorders, undiagnosed abnormal vaginal bleeding, and known or suspected hormone-dependent malignancies, such as breast cancer. The medicine is also contraindicated in cases of known or suspected missed or incomplete abortion, or known hypersensitivity to the active substance.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the officially documented manifestations of Endometrin overdosage and the emergency actions required, as stated in authoritative government regulatory documents.


Official Regulatory Guidance on Overdose

The primary clinical sign associated with an overdosage of the active ingredient, progesterone, is drowsiness (somnolence). This manifestation is related to exposure to high doses of the medication, according to regulatory prescribing information.

No specific severe outcomes, such as life-threatening cardiovascular or neurological complications, are explicitly documented in the official overdose sections of regulatory labels.

Actions Required in Case of Overdose

Official guidance mandates specific actions if an overdose is suspected or confirmed:

  • Seek Medical Guidance: Regulatory authorities explicitly advise patients to call their doctor or seek urgent medical attention if they believe they have used too much Endometrin.
  • Discontinuation of Medicine: Treatment officially consists of the discontinuation of Endometrin immediately upon overdosage suspicion.
  • Supportive Care: Management requires the institution of appropriate symptomatic and supportive care. No specific antidote is documented for progesterone overdosage in regulatory labeling.

Summary of Overdose Profile

Feature Regulatory Documentation Status
Documented Symptom Drowsiness (Somnolence)
Specific Antidote None documented
Required Action Discontinuation and Supportive Care
Urgent Help Required Yes, contact a doctor or seek urgent attention

Therapeutic Uses of Endometrin

What Endometrin Treats: Main Uses and Benefits

Enhancing Uterine Support for Pregnancy

The medication is applied across therapeutic domains where supportive management of physiological imbalance is generally needed in women undergoing Assisted Reproductive Technology (ART) procedures, such as In Vitro Fertilization (IVF). The medication is applied in addressing conditions characterized by systemic imbalance during the early stages of pregnancy and the luteal phase.

This medication may be part of symptomatic management to help women with fertility goals, including luteal phase support. It helps address symptoms related to systemic imbalance by providing essential hormonal support.

Quick Fact: Relevant for managing symptoms related to Systemic Imbalance


Supporting Implantation and Functional Stability

This medication is considered relevant for managing symptoms related to organ-specific functional stress by supporting the uterine lining in preparation for implantation. It is relevant for easing challenging symptoms during the critical luteal phase. By contributing to the maintenance of progesterone levels during this period, this product may assist with maintaining functional stability when the body requires additional support.

“This supportive therapy is relevant for easing distress and supports patients during episodes of heightened discomfort.”

Regulatory References

  1. NIH MedlinePlus overview of Progesterone Vaginal

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

Endometrin is indicated exclusively for infertile women undergoing an Assisted Reproductive Technology (ART) treatment program, specifically for luteal phase support. Use is strictly limited to the first trimester of pregnancy within this regimen.

Category Official Regulatory Statement
Populations for whom use is allowed Infertile women in an ART treatment program.
Contraindicated Populations Individuals with severe liver disease, undiagnosed vaginal bleeding, a history of blood clots (thromboembolism), or known/suspected malignancy of the breast or genital organs.
Age-Related Limitations Efficacy has not been clearly established in women 35 years of age and older. No relevant use is documented for the pediatric or geriatric population.
Physiological Restrictions Use is contraindicated in cases of known missed abortion or ectopic pregnancy. It is not recommended for individuals who are breastfeeding/lactating.
Conditional Use Patients with a history of depression, diabetes, renal dysfunction, or conditions like epilepsy/migraine require close observation or cautious use due to labeled risks. The medicine should not be used with other vaginal products, as this may alter absorption.

What should I know about interactions with other medicines?

The official regulatory profile for Endometrin identifies two primary types of documented interactions. All statements in this section are based strictly on authoritative government regulatory labeling.

Pharmacokinetic Reduction via Enzyme Induction

The regulatory prescribing information identifies medicines that may increase the rate of progesterone clearance. This is a pharmacokinetic interaction linked to the hepatic cytochrome P450 3A4 (CYP3A4) system. Drugs that induce this enzyme system may increase the elimination rate of progesterone, which is formally described as leading to reduced systemic exposure.

Specific examples of medicines explicitly listed in official documents as CYP3A4 inducers include:

  • Rifampin
  • Carbamazepine

Local Administration Interference

A local restriction is documented due to the product's route of administration. Official labeling states that co-administration with other vaginal products is not recommended. This prohibition includes products such as antifungal treatments and is established because the presence of other substances may physically alter the progesterone release and absorption from the vaginal insert.

Interaction Profile Structure

The established interaction structure is defined by these two restrictions. Regulatory documents do not contain explicit formal documentation for transporter-mediated interactions, pharmacodynamic interactions leading to synergistic effects, or interactions with food, alcohol, or herbal products.

Mechanism of Action

Endometrin Mechanism of Action

Endometrin's mechanism is driven by its active component, progesterone, a naturally occurring steroid hormone. The drug is administered locally, allowing for high concentration within the uterine lining. Its primary action is initiated within domains involving receptor-mediated signaling.

Progesterone functions as an agonist, binding to and activating the intracellular nuclear progesterone receptor (PR) in target endometrial cells. This interaction directly influences gene transcription, acting as a molecular switch to modulate specific signaling sequences. The resulting change in gene expression controls downstream cellular processes.

One critical consequence is the morphological transformation of the endometrium. Progesterone converts the estrogen-primed proliferative uterine lining into a specialized secretory endometrium. This process modifies the tissue's structural characteristics and architecture. This action influences physiological responses within targeted uterine pathways, promoting a localized change in tissue homeostasis and altering the tissue's capacity for implantation.

Dosage and Administration Information

Administration Guidelines for Endometrin

Endometrin is administered exclusively via the intravaginal route as a 100 mg vaginal insert (lyophilized tablet). The core principle of its use is dictated by the specific timing of an Assisted Reproductive Technology (ART) cycle, establishing a standardized pattern of administration.


Dosing and Scheduling Principles

The standard labeled dose is 100 mg per administration, following a divided daily frequency of two or three times daily (BID or TID). This regimen establishes the consistent daily input of the medicine required during the treatment period. The treatment protocol is strictly time-bound, mandating that administration must start the day after oocyte retrieval.

Once initiated, the treatment is continued for a duration of up to 10 weeks total if pregnancy is confirmed. If a dose is missed, the dose should be administered as soon as it is remembered, with the next dose taken at its usual time.


Procedural Constraints

The vaginal insert requires the use of the specific applicator provided with the product for proper placement. Administration with other vaginal products (such as antifungal products) is not recommended. Furthermore, specific guidance notes that the efficacy in women 35 years of age and older has not been clearly established, nor has the appropriate dose in this age group been definitively determined.

These instructions collectively define the standardized route, dosage, frequency, and time-frame required for using this medication.

Recent Clinical Evidence

Research evidence / Overview of studies for Endometrin

Evidence for Luteal Phase Support in Assisted Reproductive Technology (ART)

The research foundation for Endometrin centers on studies exploring the medicine's role in the treatment known as Luteal Phase Support (LPS) for women undergoing Assisted Reproductive Technology (ART) procedures, such as In Vitro Fertilization (IVF). The core evidence stems from large-scale Randomized Controlled Trials (RCTs). These trials were primarily used to study the medicine relative to an active comparator—meaning it was evaluated alongside another established vaginal progesterone formulation.

These studies were conducted on women between 18 and 42 years of age who were infertile and participating in an ART program. Researchers monitored two primary types of outcomes. First, they looked at clinical outcomes, such as the ongoing pregnancy rate (defined by the detection of a fetal heartbeat) and the live birth rate. Second, they used physiological endpoints to examine the drug's effects on the body, including monitoring changes in the uterine lining (endometrial transformation) and tracking the concentration of progesterone in the blood (serum progesterone concentrations).

Regulatory evaluations described patterns in clinical outcomes. Research also described the expected physiological effects: studies reported that the medicine was observed in supporting the necessary secretory changes in the uterine lining, which is the expected physiological stage needed during the luteal phase. Data also showed patterns related to the absorption and elevation of progesterone levels in the blood after administration.


Long-Term Studies and Follow-Up Duration

The typical follow-up for the primary efficacy data was relatively short-term, covering approximately 10 weeks of gestation (which starts after oocyte retrieval). This defined time interval allowed researchers to assess the outcomes for the treatment's specific purpose of providing Luteal Phase Support.

Consequently, long-term effects are not fully established beyond the 10-week trial duration. There is limited information for outcomes related to the mother's or child's health that may only become apparent years after birth.


Evidence in Specific Patient Populations

Research examined the data for the subgroup of women 35 years of age and older, and findings indicated that the evidence was limited regarding patterns observed in the younger study population. Therefore, results apply only to the populations studied, and data for certain groups remain insufficient.

Frequently Asked Questions (FAQ)

Common questions about Endometrin (FAQ)

Q: Does Endometrin need to be refrigerated?

A: Official storage requirements state the medicine must be kept at Controlled Room Temperature, typically 20 C to 25 C. The regulatory instructions explicitly advise against refrigerating or freezing the vaginal inserts.

Q: How quickly does Endometrin start to work after using it?

A: Pharmacokinetic studies, which examine how the body handles the medicine, show that the maximum concentration left(Cmax ight) of progesterone in the blood is reached between approximately 17 and 24 hours after a single dose. These studies indicate that steady-state concentrations are typically attained within about one day after starting the treatment regimen.

Q: How long does the progesterone from Endometrin stay in the body?

A: Progesterone is metabolized primarily by the liver and is then eliminated through both the kidneys and bile. Pharmacokinetic studies show that minimum average concentrations left(Cmin ight) are sustained in the blood 24 hours after each dose once steady-state is reached, demonstrating continuous presence in the body while following the prescribed daily schedule.

Q: Is Endometrin the same as progesterone oil injections?

A: Endometrin is a solid-dose vaginal insert, while progesterone in oil (PIO) is an intramuscular injection. Both formulations contain the same bio-identical hormone, progesterone. However, official information indicates that the route and method of administration differ, which can lead to different local effects and user experiences.

Q: Is it normal to have discharge after using the Endometrin insert?

A: Vaginal discharge is listed in official documents as a common adverse reaction associated with vulvovaginal disorders. This occurrence is considered typical for the dosage form and is often due to the residual components of the insert as it dissolves.

Q: Is the vaginal discharge from Endometrin concerning?

A: While vaginal discharge is a common side effect, official safety information states that the medicine is contraindicated in cases of undiagnosed abnormal vaginal bleeding. Official safety information notes that unexpected vaginal bleeding is a symptom that should be reported to a healthcare provider.

Q: Can Endometrin cause stomach upset or digestive issues?

A: Yes, common adverse reactions listed in official documents include abdominal distension (which is a form of bloating), abdominal pain, and nausea. These effects are typically listed in the Gastrointestinal Disorders section of official prescribing information.

Q: Can Endometrin cause temporary weight changes or bloating?

A: Official prescribing information lists abdominal distension (bloating) as a very common adverse reaction. Bloating is often associated with fluid retention, which can cause temporary weight fluctuations.

Q: Can using Endometrin cause irritation or burning?

A: Official labeling includes a burning sensation as a possible symptom associated with vulvovaginal disorders, which are listed as a common side effect. Local irritation is also listed as a common adverse reaction.

Q: How does Endometrin affect mood or cause emotional changes?

A: Mood changes or depression are listed as common adverse reactions in official prescribing information. Official warnings state that patient populations with a history of depression are noted to require close observation during treatment.

Q: How does Endometrin affect hormone levels in the body?

A: The active ingredient, progesterone, increases progesterone levels in the body to support the uterine lining. Beyond this primary action, progesterone is also noted in regulatory-related literature to have functional antiestrogenic effects in certain tissues and can have antigonadotropic activity.

Q: Does Endometrin contain any ingredients people are commonly sensitive to?

A: The medicine is strictly contraindicated in individuals with a known previous allergic reaction to progesterone or any of the inactive ingredients used in the insert. This contraindication covers both the active substance and any inactive ingredients in the insert.

Q: What are the known severe side effects that require immediate attention?

A: Serious adverse reactions, such as those related to blood clots (thromboembolic events) or severe allergic reactions, are documented. Regulatory documents list specific warning signs for serious adverse reactions that warrant immediate medical evaluation, including sudden shortness of breath, severe headache, sudden vision changes, or swelling of the face or throat.

Q: Can Endometrin interact with blood thinners?

A: Official documents do not list a direct drug interaction between Endometrin and blood thinners. However, the medicine is contraindicated in individuals with a history of active arterial or venous thromboembolism (blood clots), which are the conditions often treated with blood thinners.

Q: Can Endometrin interact with antidepressant medications?

A: Official regulatory documents do not contain explicit formal documentation regarding interactions with antidepressant medications. However, patient populations with a history of depression are noted in official warnings to require close observation during use.

Q: Are there any herbal supplements that should be avoided while using Endometrin?

A: Official regulatory documents do not provide specific documentation for formal interactions with herbal products. Official labels include the general informational requirement that patients inform a healthcare provider of all prescription medicines, over-the-counter products, and supplements being used.

Q: Is it common for doctors to prescribe Endometrin after IUI?

A: Endometrin is formally indicated for Luteal Phase Support as part of an Assisted Reproductive Technology (ART) treatment program for infertile women. The indication is for Luteal Phase Support and begins the day after oocyte retrieval, a specific step in IVF procedures.

Q: Is it necessary to have certain tests done before starting Endometrin?

A: Regulatory instructions advise that the patient and partner should be assessed by a healthcare provider for causes of infertility before starting treatment. This assessment is outlined in regulatory instructions to ensure the medicine's appropriate use.

Q: What kind of studies have been done on the use of Endometrin?

A: The foundational evidence for the medicine is derived from clinical studies, including Randomized Controlled Trials (RCTs). These trials were primarily conducted on infertile women undergoing an Assisted Reproductive Technology (ART) program to assess the drug's role in Luteal Phase Support.

Q: Are there long-term effects of using Endometrin that studies have looked at?

A: The primary efficacy studies typically followed women for approximately 10 weeks of gestation. Regulatory documents note that long-term effects on the mother or child are not fully established beyond the time frame of these specific clinical trials.

Q: How is Endometrin generally stopped once a person completes the treatment plan?

A: Regulatory information warns that if the medicine is stopped suddenly, there is a risk of increased anxiety, moodiness, and increased sensitivity to seizures. Discontinuation guidance is typically provided by a healthcare provider.

Q: Why do some people experience spotting while using Endometrin?

A: Official labeling lists vaginal bleeding as a possible side effect of the medicine. Any unexpected vaginal bleeding is a symptom that should be reported to a healthcare provider.

How should Endometrin be stored and disposed of?

Storage and Disposal Requirements for Endometrin

Endometrin vaginal inserts must be stored at Controlled Room Temperature (CRT), which is 20 C to 25 C (68 F to 77 F). The regulatory labeling permits excursions between 15 C and 30 C.

It is prohibited to refrigerate or freeze the medicine. The inserts must be protected from both moisture and direct heat or sunlight. To preserve stability, the product must be kept in its original sealed packaging until the moment of use.

All medicine must be stored out of the reach of children. Unused or expired Endometrin and the single-use applicator should be disposed of in accordance with local requirements, which often involves returning it to a pharmacist or clinic.

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

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