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Ovinum

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Ovinum

Ovinum_FR

Method of action: Antiestrogenic, Sex Hormones And Modulators Of The Genital System

Treatment option: Infertility, Galactorrhea, Polycystic Ovarian Syndrome

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 Ovinum

Quick Facts

Property Description
Active Ingredient Clomifene Citrate
Form Oral Tablet
Pharmacological Class Selective Estrogen Receptor Modulator (SERM)
Common Use Ovulation Induction in specific patient groups
Origin Synthetic, Nonsteroidal

What is Ovinum and What Type of Medicine Is It?

Ovinum is a prescription-only, synthetic nonsteroidal pharmaceutical agent whose active ingredient is Clomifene Citrate. It is primarily classified as a Selective Estrogen Receptor Modulator (SERM) and functions as a Synthetic Ovulation Stimulant. Clomifene is utilized to induce ovulation in women with anovulation. This means the medication is the standard starting point, clinically recognized for its role, for women who need support releasing an egg. As a nonsteroidal compound, Ovinum works indirectly to influence reproductive hormones, distinguishing it from hormonal drugs that introduce hormones directly into the system. This formulation is orally administered and generally aimed at the patient group experiencing difficulty with natural ovarian function.

Clomifene Citrate: Form and Composition

The sole active ingredient in Ovinum is Clomifene Citrate, which is delivered to the patient as an orally administered tablet. Clomifene Citrate is a synthetic chemical derivative, confirming that the drug is manufactured rather than being sourced from natural compounds. The medication is a single-active-ingredient product, combined with standard pharmaceutical excipients necessary to form the tablet dosage form. The drug works by blocking estrogen receptors in the body. This core property is what allows the medication to adjust the body's reproductive signals, offering a non-invasive treatment option compared to injectable alternatives.

What is the General Purpose of Ovinum?

The general purpose of Ovinum is to induce ovulation in women who experience infertility due to the absence or irregularity of egg release (ovulatory dysfunction). It achieves this by creating a temporary, perceived state of estrogen deficiency in the brain's regulatory centers. This antiestrogenic effect prompts the pituitary gland to significantly increase the output of Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH), thereby providing the necessary hormonal boost to restart the natural cycle of follicle maturation. This fundamental action is what makes the medication useful in restoring the potential for conception. This approach is a well-established intervention for this specific patient population.

Regulatory References

  1. NICE Guideline on Fertility

What side effects are possible with Ovinum?

Possible Side Effects and Safety Information

The safety profile of Ovinum (Clomifene Citrate) is defined by adverse reactions classified according to their frequency and the physiological system affected, as documented in official regulatory sources like the FDA and EMA. The most frequently reported adverse reactions are generally related to temporary hormonal effects.

Frequency-Classified Adverse Reactions

Side effects are categorized based on their incidence in clinical data:

  • Common Reactions (occurring in ge 1% of users) include vasomotor flushing (hot flushes), ovarian enlargement, abdominal discomfort or pelvic pain, headache, nausea, vomiting, and blurred vision.
  • Uncommon or Rare Reactions include severe visual disturbances (such as scotomata or photopsia), allergic reactions, pancreatitis, and thromboembolic events.

Systemic and Serious Safety Considerations

The medication's effects are primarily concentrated in the Reproductive System and Visual System.

  • Serious Adverse Reactions officially documented include Ovarian Hyperstimulation Syndrome (OHSS), severe and prolonged visual impairment (which may be irreversible), and an elevated risk of ovarian neoplasms associated with prolonged use (typically exceeding six treatment cycles).

Safety Restrictions and Duration-Related Patterns

The official label mandates specific restrictions and notes related to exposure:

  • The incidence of visual symptoms is documented as increasing with the total cumulative dose or duration of therapy.
  • Ovinum is contraindicated in women who are pregnant or suspected of being pregnant, and in patients with active liver disease, a history of liver dysfunction, or undiagnosed abnormal uterine bleeding.
  • Caution is advised when used in patients with pre-existing uterine fibroids or those with a history of hyperlipidemia.

This regulatory structure ensures that patients and healthcare providers understand the common occurrences and the specific serious risks tied to the use and duration of treatment.

Overdose and Emergency Response

Overdose and When to Seek Help

Officially documented overdose presentations for Clomifene Citrate (Ovinum) primarily involve sensory and gastrointestinal manifestations. The documented signs and symptoms reported in overdose situations include Nausea, Vomiting, and Vasomotor Flushes. Dose exposure is associated with Abdominal or Pelvic Pain and Ovarian Enlargement. Of particular concern are Visual Disturbances, such as Blurred Vision and Scintillating Scotomata (visual spots or flashes), which must be monitored.

Severe Manifestations and Emergency Action

Overdose exposure carries the risk of severe outcomes, including Potentially Irreversible Visual Disturbances. Furthermore, the use of clomiphene citrate is associated with the development of Ovarian Hyperstimulation Syndrome (OHSS), which in its severe form is explicitly documented as life-threatening.

Due to these serious risks, official regulatory documents mandate that all users Seek Emergency Medical Attention immediately if an overdose is suspected. Users should also contact a Poison Control Center. Management protocols described in official documents confirm that no specific antidote is known for clomifene citrate. Treatment involves Appropriate Supportive Measures and procedures, such as Gastric Lavage. Prolonged medical observation may be indicated following an overdose event.

Therapeutic Uses of Ovinum

Ovinum (clomiphene citrate) may assist with the core therapeutic domain of reproductive medicine. Its main role is commonly used to help with anovulatory or oligo-ovulatory infertility in women who are desiring pregnancy. The medication provides support that helps ease the overall symptom burden related to the natural cycle.

Main Uses and Benefits

This supportive treatment is applied in addressing conditions where functional stability becomes affected by a lack of regular, predictable ovulation, which is one of the symptoms that interfere with daily functioning. This medication is commonly used across conditions presenting with acute episodes of anovulation, especially those with conditions like Polycystic Ovary Syndrome (PCOS) or post-oral-contraceptive amenorrhea.

By promoting ovulation, it contributes to easing the overall symptom load associated with inconsistent cycles, and supports general well-being during symptomatic phases. Furthermore, it is sometimes commonly used to help with male infertility, a usage that is relevant for easing the symptoms linked to organ-specific functional stress related to that condition.

The patient benefit is focused on symptomatic support: “Ovinum may help patients cope more steadily with symptom fluctuations related to ovulatory inconsistency.” The overall goal is to support the patient during episodes of reproductive imbalance and help maintain a sense of stability.

General Symptom Support: Relief for symptoms related to systemic imbalance

Regulatory References

  1. NIH MedlinePlus overview of Clomiphene

Eligibility and Restrictions for Use

Who Can and Cannot Use Ovinum (Clomiphene Citrate)

This medicine is restricted to a highly specific patient population, based on official regulatory labeling for the active substance clomiphene citrate. Eligibility is generally limited to adult women who experience ovulatory dysfunction and are seeking to become pregnant.

Populations That Must Not Use Ovinum (Contraindicated)

Category Reason for Exclusion
Pregnancy Absolute contraindication due to potential for fetal harm.
Liver Function Contraindicated in patients with liver disease or a history of impaired liver function.
Gynecological Conditions Presence of an ovarian cyst or enlargement (unless due to polycystic ovary syndrome) or abnormal uterine bleeding of undetermined cause.
Endocrine/Glandular Untreated or uncontrolled thyroid or adrenal gland disorder, or an organic intracranial lesion (e.g., pituitary tumor).
Hypersensitivity Known allergy to clomiphene citrate or any ingredients.

Conditional Use and Exclusions

Use requires caution in patients with uterine fibroids due to potential enlargement. The medication is not established for treating male infertility or for use in the pediatric population. Before starting treatment, patients must be confirmed as not pregnant, and the presence of new ovarian cysts must be ruled out prior to each course.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official prescribing information for Clomifene Citrate (Ovinum) provides specific regulatory constraints regarding co-administration with other substances and certain pre-existing patient conditions.

Documented Interaction Restrictions

Interaction Type Interaction Entity Official Constraint/Restriction
Pharmacodynamic Risk Other Ovulation-Inducing Drugs Co-administration is associated with an increased risk of Ovarian Hyperstimulation Syndrome (OHSS), a severe adverse outcome.
Population-Specific Risk Pre-existing Hyperlipidemia Risk of developing severe hypertriglyceridemia during treatment; patient monitoring is required.

Drug interactions with Clomifene Citrate have not been documented in the official regulatory prescribing information concerning common pharmacokinetic mechanisms, such as those mediated by CYP enzymes or drug transporters. Therefore, no formal restrictions regarding these types of metabolic interactions are listed in the official labeling. The interaction profile focuses primarily on pharmacodynamic risks when combined with other agents that stimulate ovulation. Additionally, there are no documented mandatory timing-separation rules concerning food, alcohol, or other medicinal products.

Mechanism of Action

The fundamental mechanism of Clomifene Citrate is exerted by its action as a competitive antagonist at Estrogen Receptors (ER) primarily in the hypothalamus. By blocking the receptors, the drug prevents the engagement of the estrogen negative feedback loop. This molecular blockade results in the central neuroendocrine system functionally perceiving a state of estrogen deficiency, which supports the initiation of Gonadotropin-Releasing Hormone (GnRH) release. The increased GnRH signaling stimulates the pituitary gland to secrete significantly higher concentrations of Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH). This hormonal surge acts on the ovaries, promoting the growth and maturation of follicles, an indirect stimulatory effect that supports the natural LH surge and subsequent follicular rupture. Clomifene Citrate is also a Selective Estrogen Receptor Modulator (SERM). This means it exhibits a dual profile, acting as an antagonist centrally but having mixed antiestrogenic properties on peripheral tissues like the cervix and endometrium. This peripheral action can constrain the physiological consequences downstream by modulating the characteristics of cervical mucus and reducing endometrial proliferation.

Dosage and Administration Information

How to Use Ovinum

Ovinum (Clomifene Citrate) is a prescription medicine used according to a standardized, time-bound cyclic regimen established in pharmaceutical protocols. The drug is available as a 50 mg tablet and is administered through the oral route.

Standard Labeled Administration

The treatment is structured around specific dosage and timing patterns:

Usage Domain Official Administration Principle
Starting Dose The initial course begins with 50 mg once daily for five consecutive days.
Dose Escalation The dose may be increased to 100 mg once daily for five days only if the desired response is not achieved after the first course. Standard protocols specify that treatment should not exceed 100 mg daily.
Timing The first course typically begins on or about the fifth day of the menstrual cycle. If a patient has no recent uterine bleeding, therapy may commence at any time.
Cycle Interval A minimum interval of approximately 30 days is required between any two successive courses.

Contextual Use Principles

The usage protocol includes mandatory procedural requirements. Treatment is conducted under the supervision of physicians experienced in gynecologic or endocrine disorders. A pelvic examination is required prior to the initiation of the first course and before starting each subsequent course. Established guidelines limit long-term cyclic therapy to a total of about six courses over a patient's lifetime. For certain clinical scenarios, such as Polycystic Ovary Syndrome (PCOS), standard instructions specify starting at the lowest recommended dose (50 mg) for the shortest duration.

Recent Clinical Evidence

Research evidence / Overview of studies for Ovinum

Evidence for Use in Ovulation Induction

Research evidence for Ovinum (Clomifene Citrate) includes Randomized Controlled Trials (RCTs) and Systematic Reviews that synthesize data from individual trials. These studies were used in research exploring symptoms for women who experience infertility due to irregular or absent egg release. Researchers monitored key outcomes, specifically examining if women ovulated and if a clinical pregnancy resulted. Ovinum was evaluated in adult women with anovulatory infertility, often comparing it to placebo or other medications.

Studies reported patterns where ovulation was observed in a proportion of women after treatment cycles. Research reports changes measured during the study period concerning pregnancy rates. The trials also monitored for the incidence of multiple follicular development, which was associated with an elevated rate of multiple pregnancies (e.g., twins or triplets) in the treated populations.

Research Focused on Polycystic Ovary Syndrome (PCOS)

A significant portion of the evidence specifically was studied for women with Polycystic Ovary Syndrome (PCOS). Comparative research involved RCTs where Ovinum was compared against other medications that were evaluated for use in PCOS. In these studies, findings were mixed when comparing the reported live birth rates for Ovinum versus the comparator agents in women with PCOS.

Evidence for Use in Male Infertility

Ovinum was evaluated in smaller-scale clinical investigations and systematic reviews that explored its use in certain types of male infertility, such as in men with low sperm concentration (oligozoospermia) or low testosterone levels. These studies explored changes in sperm concentration, sperm motility, and hormonal levels.

Research so far data indicate patterns related to measured increases in some sperm parameters and testosterone levels during the study period. However, the evidence is limited and considered heterogeneous (mixed) because the trials were generally small, and findings regarding the ultimate outcome—clinical pregnancy—were not consistent across all studies.

What Remains Uncertain in the Research Record

One key limitation is the existence of a subgroup of women (Clomifene-resistant) who show a limited or no response to the medication; data for certain groups remain insufficient to predict who falls into this group or to establish optimal subsequent research pathways. The findings describe group patterns, not personal outcomes; research provides context but not individual predictions about how an individual may respond. Additionally, the long-term effects are not fully established beyond the observation periods of the primary clinical investigations.

Key Studies & References Clomiphene Oral - MedlinePlus Drug Information (NIH)

Frequently Asked Questions (FAQ)

Common questions about Ovinum (FAQ)

Q: What is Ovinum used for?

A: Ovinum is indicated for the management of chronic, non-malignant pain in adult patients who have not responded adequately to other pain medications. Its approved use is specifically detailed in the official product labeling.

Q: How should I store Ovinum?

A: The official labeling indicates that Ovinum should be stored at room temperature, away from moisture and heat. It is important to keep the medication in its original container and out of reach of children.

Q: What happens if I miss a dose of Ovinum?

A: If a dose is missed, it is generally advised to take the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose, the official guidance often suggests skipping the missed dose and continuing with your regular schedule. Always consult the detailed instructions provided by your pharmacist or healthcare provider regarding missed doses.

Q: Can Ovinum cause dependence?

A: Like many medications used for chronic pain, there is a potential for physical dependence and withdrawal symptoms upon abrupt cessation. This risk should be discussed with a healthcare professional, and the medication should only be discontinued under their supervision.

How should Ovinum be stored and disposed of?

How to Store and Dispose of Ovinum

Ovinum (Clomiphene Citrate tablets) must be stored strictly according to official regulatory requirements to ensure product integrity and stability.

Storage Conditions

The tablets require storage at controlled room temperature, typically between 15 C and 30 C. It is mandatory to keep the medication in its original container, tightly closed, and protect it from excessive heat, light, and moisture. The product must be kept from freezing and should not be used past the expiry date (EXP) .

Child Safety

For safety, this medication must be stored out of the reach and sight of children, and safety caps should always be locked.

Disposal Requirements

Unused or expired Ovinum must not be thrown away via household waste or flushed down the toilet (wastewater). Disposal must be handled according to local and national regulations; consult a pharmacist or local authority for proper disposal methods.

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

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