Orgametril

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Orgametril

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Orgametril

Property Description
Active ingredient Lynestrenol
Form Oral tablet (Solid state formulation)
Pharmacological class Synthetic Progestogen (Hormonal Agent)
General purpose Hormonal regulation and contraception
Origin Synthetic (19-Nortestosterone derivative)

Orgametril: Definition, Origin, and Pharmacological Class

Orgametril is a medicine containing the single active ingredient Lynestrenol, which is a powerful synthetic progestogen and a hormonal agent utilized for reproductive system regulation. Lynestrenol is classified as a progestin used for contraception and in the treatment of menstrual disorders. This regulatory capacity is clinically recognized for its effectiveness in stabilizing female hormonal systems. Chemically, Lynestrenol is an estrane steroid, specifically a 19-nortestosterone derivative, establishing it as a highly specific, synthetically engineered compound that structurally differs from the natural hormone progesterone.

Composition and Pharmaceutical Form of Lynestrenol

The active substance, Lynestrenol, is consistently supplied as an oral tablet formulation, which represents a solid state, single-ingredient product designed for convenient administration. Lynestrenol functions as a prodrug, meaning the administered compound must first undergo metabolism in the liver to become biologically active. Lynestrenol is rapidly and almost completely converted into its active metabolite, Norethisterone, in the liver. This conversion is critical, as it is Norethisterone that acts as the primary progestational hormone by binding to specific progesterone receptors in the body. The product is positioned as a reliable oral therapy, distinguishing it from formulations requiring alternative delivery methods.

General Purpose as a Hormonal Regulator

The general function of Orgametril is to serve as a reliable hormonal regulator by delivering controlled synthetic progestin support, which is essential for modulating the female reproductive cycle. By introducing this powerful progestogen, the medication reliably affects the cyclical changes within the uterus, including the growth and stability of the uterine lining (endometrium). This regulatory action is fundamental to its utility in balancing hormonal states, such as managing irregular menstrual patterns, and is a recognized function for serving as a foundational component in hormone-based contraception.

Regulatory References

  1. Serum levels and pharmacokinetics of norethisterone after ingestion of lynestrenol: its relation to dose and stage of the menstrual cycle - PubMed

What side effects are possible with Orgametril?

Possible Side Effects and Safety Information

The safety profile of Orgametril (lynestrenol) is documented in official regulatory sources, with adverse reactions categorized by frequency and the organ system affected. The most frequently documented effects are generally related to the medication's hormonal nature.

Frequency-Classified Adverse Reactions

Adverse reactions are classified based on the incidence reported in clinical use:

  • Common (may affect up to 1 in 10 people): Included effects are headache, depressed mood, nervousness, nausea, vomiting, weight increase, and changes to bleeding patterns such as breakthrough bleeding or spotting.
  • Uncommon (may affect up to 1 in 100 people): Documented effects include migraine, dizziness, acne, hirsutism (excessive hair growth), and changes in libido or weight decrease.
  • Rare and Not Known effects: These categories cover occurrences such as hypersensitivity reactions and specific disturbances in liver function.

Serious Safety Considerations

The official labeling notes the risk of serious adverse reactions associated with the progestogen class. These include the potential for Venous Thromboembolism (VTE), which comprises Deep Vein Thrombosis and Pulmonary Embolism, and a rare association with hepatic neoplasms (liver tumours).

Population-Specific Safety Restrictions

Specific safety constraints are explicitly stated in regulatory documentation. The medicine is contraindicated in individuals with conditions such as severe liver disease or liver tumours, known or suspected pregnancy, or a past history of venous thromboembolic disease. Furthermore, those with a tendency toward chloasma (skin darkening) are advised to limit exposure to sun or UV radiation while on the medication.

Overdose and Emergency Response

Overdose and When to Seek Help

The information regarding overdose for Orgametril (lynestrenol) is based strictly on documentation from governmental regulatory sources, which outlines the specific clinical manifestations that have been reported.

Documented Overdose Presentations

Official regulatory documents indicate that an overdose, while generally not associated with severe life-threatening outcomes, may result in specific adverse events. The primary documented signs of a suspected overdose include:

  • Nausea
  • Vomiting
  • Vaginal bleeding

These symptoms primarily affect the gastrointestinal and reproductive systems.

Required Emergency Action

If an overdose of this medicine is suspected, you must contact your doctor immediately. This instruction is a direct requirement stated in the official regulatory prescribing information. Immediate medical consultation is required to assess the symptoms, particularly if vaginal bleeding or significant gastrointestinal distress occurs.

Overdose Context

While specific dose levels leading to overdose are not typically detailed in patient information, the focus remains on recognizing these key symptoms and ensuring prompt medical attention. The official profile does not classify these overdose symptoms by severity but mandates immediate professional consultation upon suspicion.

Therapeutic Uses of Orgametril

What Orgametril Treats: Main Uses and Benefits

Orgametril (lynestrenol) is applied across domains where additional symptomatic support is needed, particularly for conditions that impact the female reproductive system. This medication is relevant for easing a variety of uses, focusing on symptom management and stability. It is commonly used across conditions presenting with acute episodes of symptoms related to physical discomfort, such as heavy or prolonged menstrual bleeding, irregular cycles, and painful periods.


Addressing Symptom Burdens and Functional Discomfort

This medication is commonly used to help with symptom clusters that may become intense or disruptive, and is applied when symptoms create noticeable interference with daily comfort. It contributes to easing the overall symptom load and helps improve day-to-day comfort during symptomatic periods. It is often used when symptoms intensify and supportive relief is needed.

Stabilizing Hormonal Symptom Patterns

Orgametril is applied in addressing conditions characterized by periods of heightened symptoms or fluctuating manifestations, including those that create noticeable physiological strain. It may assist with maintaining a sense of stability when symptoms are more noticeable, and may provide temporary assistance in addressing symptom fluctuations used in settings marked by temporary physiological imbalance.


Quick Fact: Relief for Symptoms that interfere with daily functioning

Regulatory References

  1. Haute Autorité de Santé (HAS) overview of ORGAMETRIL

Eligibility and Restrictions for Use

Who Can and Cannot Use Orgametril?

Eligibility for Orgametril (Lynestrenol) is strictly defined by official regulatory documentation and is based on a patient’s current physiological state, existing medical history, and specific comorbidities. The medicine is primarily intended for females of reproductive potential.


Absolute Contraindications

Orgametril is contraindicated and must not be used by individuals with the following conditions:

Classification Prohibited Use Status
Pregnancy Status Known or suspected pregnancy
Vascular Health Active venous thromboembolic disorders (VTE)
Organ Function Severe liver disease or liver tumors
Cancer Risk Progestin-sensitive malignancies (e.g., breast cancer)
Other Undiagnosed abnormal uterine bleeding

Restricted and Non-Recommended Use

Certain populations have specific limitations or regulatory warnings for use:

  • Lactation (Breastfeeding): Use is not recommended as the drug may decrease milk production.
  • Metabolic Conditions: Females with diabetes or prediabetes require special monitoring due to potential metabolic effects.
  • Hypertension: The drug is contraindicated if hypertension is uncontrolled, and blood pressure must be monitored closely if use continues.
  • Age Groups: Use in pediatric and geriatric populations is generally not established.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Orgametril (Lynestrenol) interactions are primarily defined by changes in its metabolism due to co-administered substances, as documented in official regulatory sources.

Pharmacokinetic Interactions

Classification Interacting Agents (Examples) Official Outcome Statement
Exposure-Reducing Hepatic Enzyme Inducers (e.g., Rifampicin, Carbamazepine, Phenytoin) Officially documented to decrease the systemic exposure of the active progestogen, potentially leading to reduced efficacy of Orgametril.
Exposure-Increasing Hepatic Enzyme Inhibitors (e.g., Ketoconazole, Erythromycin) May increase the systemic exposure to the active progestogen, which is officially noted as potentially increasing the risk of adverse effects.

Pharmacodynamic and Substance Interactions

Certain official documents note that Orgametril may reduce the anticoagulant activities of medicines such as Warfarin or Acenocoumarol. Furthermore, the therapeutic efficacy of Antidiabetic Agents may be decreased due to the progestogen's potential influence on glucose tolerance.

The herbal product St. John’s Wort (Hypericum perforatum) is documented to reduce the effectiveness of Orgametril due to its enzyme-inducing properties. No mandatory timing or separation rules are explicitly defined in the core regulatory labeling. A key population-specific restriction is that patients with severe hepatic impairment are contraindicated, as this condition critically influences the metabolism required for all documented pharmacokinetic interactions.

Mechanism of Action

The mechanism of action for Orgametril relies on its single active ingredient, Lynestrenol, which functions as a synthetic progestogen by targeting key regulatory systems.

Prodrug Activation and Receptor Agonism

Lynestrenol is a prodrug that becomes biologically active only after rapid conversion by hepatic enzymes into its metabolite, Norethisterone. This active form acts as a strong agonist by binding to and activating the Progesterone Receptor (PR), initiating a molecular cascade that alters the transcription of target genes in reproductive tissues.


Central Hormonal Axis Suppression

This PR activation exerts negative feedback on the Hypothalamus-Pituitary-Ovarian (HPO) Axis, suppressing the release of Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH). This centrally driven mechanism modifies the normal cyclical endocrine sequence, leading directly to the physiological consequence of anovulation (the inhibition of egg release).


Endometrial and Cervical Tissue Modulation

The active metabolite also acts directly on peripheral tissues, halting the estrogen-driven proliferation of the uterine lining and promoting its transformation into decidualization followed by atrophy. Concurrently, it alters the quality of cervical mucus, significantly increasing its viscosity to form a dense substance in the cervical canal.

Dosage and Administration Information

How to Use Orgametril (Lynestrenol)

Orgametril (Lynestrenol) is an oral progestogen medicine that must be used strictly according to the specific regimen prescribed by a healthcare professional.

Administration and Dosage Form

Administration Scope Official Instruction
Route Oral (taken by mouth).
Form & Strength 5 mg Tablet.
Dosing Pattern Daily frequency; may be cyclic or continuous based on the specific condition.
Special Conditions Take the tablet whole with a liquid. The start date is often tied to a specific day of the menstrual cycle (e.g., Day 1, Day 5, Day 14, or Day 15).

General Dosing Protocol

The standard prescribed dose is typically one 5 mg tablet daily. However, the actual daily amount may range from 5 mg to 15 mg depending on the clinical protocol.

  • Cyclic Use: For many conditions, the dose is taken for a fixed number of days per cycle (e.g., Day 15 through Day 25), followed by a scheduled break.
  • Continuous Use: For protocols such as the treatment of endometriosis, the dose may be required daily without interruption for several months.

Missed Dose: If a dose is missed, it should be taken as soon as the oversight is noticed, unless the next scheduled dose is nearly due, in which case the missed dose should be omitted.

Note: Dosage adjustments may be required for specific populations, including adolescents or patients with hepatic impairment.

Recent Clinical Evidence

Research evidence / Overview of studies for Orgametril


Heavy Menstrual Bleeding

Studies have monitored the use of this compound in conditions associated with acute or disruptive episodes, specifically focusing on heavy menstrual bleeding. The research has explored short-term symptom changes related to this condition, with a focus on outcomes reflecting daily functioning or activity level. These trials often look at patient-reported outcomes describing perceived discomfort and the measured level of blood loss.

Studies reported patterns related to measurements of reduced bleeding intensity. Findings describe patterns observed in the studies where patients reported how symptoms evolved in the observed populations during the defined time intervals. The research contributes to understanding short-term changes in outcomes related to physical discomfort.

However, it is important to understand that certainty remains low due to specific limitations. Follow-up durations were limited in many studies, meaning that long-term effects are not fully established regarding the duration of observed changes. Furthermore, results apply only to the populations studied, and evidence quality varies across studies concerning this indication.


Endometriosis

For conditions involving periods of heightened symptoms, such as endometriosis, research has examined how the compound was evaluated in settings with varying symptom burdens. The focus here has been on outcomes linked to inflammatory or irritative states and the reported presence of pain. Studies were conducted during periods of increased symptom activity to explore how outcomes related to systemic or functional imbalance may be affected.

Research indicates patterns in the measured outcomes related to physical discomfort. Research noted measured changes, and studies explored how symptom intensity was monitored during the study period. The studies contribute to the broader evidence landscape by observing responses over defined time intervals.

It is important to understand the limitations in this area. Evidence is limited for specific presentations of the condition, and comparative evidence is lacking to definitively show how this compound compares to other available options. Subgroup findings are uncertain, meaning that data for certain groups remain insufficient to make broad statements about the patterns observed.


Specific Menstrual Cycle Timing Issues

The compound was studied for its application in research contexts involving fluctuating or unstable symptoms, particularly those related to irregular bleeding patterns outside of heavy flow. Research has explored short-term symptom changes in outcomes describing episodic or acute changes to assess how cycle timing may be affected.

Studies described how the compound was evaluated for its potential in research exploring patient-reported experiences related to unpredictable bleeding. Studies described patterns related to the measurements of cycle timing in the observed populations.

The evidence for this indication can provide context, but it must be viewed cautiously. Sample sizes were modest in some of the relevant studies. Research provides context but not individual predictions, and the study results reflect the specific conditions under which they were conducted, meaning they describe group patterns, not personal outcomes.

Key Studies & References

  1. NICE Guideline NG88: Heavy menstrual bleeding: assessment and management (Referencing use of progestogens)

Frequently Asked Questions (FAQ)

Common questions about Orgametril (FAQ)


Q: How quickly does Orgametril start working after you begin taking it?

Orgametril is an inactive compound (a prodrug) that is converted rapidly by the liver into its active form. Official information for its contraceptive application suggests that its central hormonal effect is generally established after 7 consecutive days of consistent use. This indication for the contraceptive application reflects the general timeline for the central hormonal effects to be established.


Q: What happens if I forget to take Orgametril?

Official guidance states that a missed tablet should be taken as soon as the oversight is noticed, unless the next scheduled dose is almost due. If more than a specific time period has passed since the last dose, the medicine's intended effect may be reduced, and the leaflet indicates that alternative non-hormonal protection is considered necessary for a short period.


Q: Are there any common over-the-counter medicines or supplements that interact with Orgametril?

The active ingredient's effectiveness is documented to be reduced by substances known as hepatic enzyme inducers, which speed up liver metabolism. This group includes the herbal product St. John’s Wort. The primary official warnings do not explicitly list other common over-the-counter medicines as having a documented interaction.


Q: What kind of monitoring (like blood pressure checks) is recommended while on Orgametril?

Official documents advise that if a woman develops sustained hypertension (high blood pressure) or acute disturbances of liver function, such conditions warrant a specialist consultation for examination and advice. Because the medicine is associated with a risk of venous thromboembolism (blood clots), the risk factors may be subject to periodic medical review.


Q: Can women with a history of depression use Orgametril?

The official product information lists depressed mood as a common side effect of the medicine. While pre-existing depression is not an absolute contraindication, some authoritative medical guidance advises that caution should be taken in women who have a personal or family history of depression, and monitoring for mood changes is a factor often noted in discussions of the drug's use.


Q: How does Orgametril affect skin and hair?

The official safety profile lists acne and hirsutism (excessive hair growth) as uncommon side effects. Furthermore, a specific warning advises those with a tendency toward chloasma (skin darkening or brown patches) to limit exposure to sun or UV radiation while taking the medicine.


Q: What do patient information leaflets say about missed periods while on Orgametril?

The official patient information notes that changes to expected bleeding patterns are common. This includes spotting, breakthrough bleeding, irregular intervals, or sometimes a complete lack of bleeding (amenorrhea) as a documented possible pattern while using the medicine.


Q: Why do some people use Orgametril for heavy periods?

The medicine is a progestogen, and its mechanism involves acting on the lining of the uterus (the endometrium). It is documented to halt the lining’s growth and promote thinning (atrophy), a process which is related to the measured reduction in blood loss noted in studies.


Q: How is Orgametril different from other drugs used for menstrual problems, like Duphaston?

Orgametril contains the single active ingredient Lynestrenol, which is a synthetic progestogen. Different medicines prescribed for similar conditions may contain other progestogens, such as Dydrogesterone (found in Duphaston), which have unique chemical structures and slightly different properties.


Q: Is Orgametril appropriate for women who are close to menopause?

Official documents note that the active ingredient, Lynestrenol, has applications within Hormone Replacement Therapy (HRT) regimens for menopausal women. It is often used to protect the uterine lining when an estrogen is also being administered as part of a regimen.


Q: Is Orgametril available generically under another name?

The drug contains the active compound Lynestrenol, which is the official generic, non-proprietary name for the medicine. It is often sold under this active ingredient name by various manufacturers, in addition to the brand name Orgametril.


Q: Does Orgametril affect bone density over time?

Long-term safety documents specifically for this compound do not list a change in bone density as a common or serious adverse reaction. However, as it belongs to the broader class of progestogens, the effects of this drug class on bone mineral density have been topics of research and regulatory examination.


Q: Does Orgametril have any known interaction with grapefruit or grapefruit juice?

While grapefruit is not explicitly named in the official documentation for this specific medicine, the active ingredient is metabolized by specific liver enzymes (CYP3A4) that are known to be affected by grapefruit. It is understood that consuming grapefruit could potentially influence the active compound's systemic exposure.


Q: Can certain medical conditions make Orgametril less effective?

Yes, conditions that significantly impact the liver's function are listed as contraindications because the medicine relies on the liver for conversion into its active form. Any condition that critically affects the body’s ability to metabolize the drug could potentially alter its effectiveness.


Q: Does Orgametril require a specific diet or lifestyle change?

Official safety documents advise those with a tendency toward chloasma (skin darkening) to limit exposure to sun or UV radiation while taking the medicine. No specific routine dietary requirements or other broad lifestyle changes are explicitly stated in the primary regulatory warnings.

How should Orgametril be stored and disposed of?

Storage and Disposal of Orgametril (Lynestrenol)

Orgametril tablets must be stored at room temperature, generally defined as below 30 C. The medicine must be kept in its original package and the container must remain tightly closed to ensure protection from moisture and light, which maintains the integrity and stability of the Lynestrenol active ingredient. A mandatory regulatory requirement is to keep the product out of the sight and reach of children to ensure safety.

Disposal Requirements

To discard unused or expired Orgametril, the product must not be thrown into household trash or disposed of via wastewater. Official guidelines require that the medication be handled as pharmaceutical waste and disposed of according to local and national regulations for proper environmental protection.

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

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