Product image of Gynalven (Progesterone, Micronised) supplied by GNH India

Gynalven

Active Ingredient:
Progesterone, Micronised
Origin:
EU

Gynalven (Progesterone, Micronised)

Gynalven is a prescription oral medication that contains micronised progesterone as its active ingredient. It is marketed in the European Union in most EU countries and supplied as tablets (strength not specified). As a progestogen, Gynalven binds to progesterone receptors and mimics the hormone’s natural actions in the body. The product is intended for use under medical supervision and is not available over the counter.

Manufacturer / TM Owner

Itf Hellas S.A.

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Indications & Clinical Uses

Gynalven is used in hormone therapy where supplemental progesterone is required.

  • Support of the luteal phase in assisted reproductive technology cycles.
  • Management of progesterone deficiency in women with amenorrhea.
  • Adjunct therapy in estrogen‑based hormone replacement regimens to reduce endometrial proliferation.
  • Treatment of certain menstrual disorders such as irregular bleeding.
  • Prevention of preterm birth in selected high‑risk pregnancies (off‑label in some regions).
  • Preparation for endometrial priming before embryo transfer in in‑vitro fertilization protocols.

Side Effects

Side effects reported with oral micronised progesterone vary in frequency and severity. While most patients experience mild symptoms, clinicians monitor for less frequent but more serious events.

Common

  • Nausea, abdominal discomfort, or mild gastrointestinal upset.
  • Drowsiness, fatigue, or a feeling of reduced alertness.
  • Breast tenderness, swelling, or a sensation of fullness.
  • Headache, often mild and transient.
  • Transient dizziness or light‑headedness, especially when standing quickly.

Serious

  • Allergic reactions such as rash, itching, swelling of the face, lips, or tongue.
  • Signs of venous thromboembolism, including unexplained leg pain, swelling, or shortness of breath.
  • Severe mood changes, depression, or thoughts of self‑harm.

Precautions & Warnings

Before prescribing Gynalven, healthcare providers consider several precautionary factors to ensure safe use.

  • Assess for a history of thromboembolic disorders or clotting disorders.
  • Evaluate liver function, as progesterone metabolism occurs hepatically.
  • Review any personal or family history of hormone‑sensitive cancers.
  • Consider potential effects on mood; screen for depression.
  • Use caution in patients with uncontrolled hypertension.
  • Avoid in women who are pregnant unless specifically indicated.
  • Check for known hypersensitivity to progesterone or excipients.

Avoid Interactions

Oral micronised progesterone can interact with other medicines, affecting efficacy or safety.

Avoid

  • Combined use with strong CYP3A4 inducers (e.g., rifampin, carbamazepine) may reduce progesterone levels.
  • Concurrent anticoagulant therapy (warfarin, direct oral anticoagulants) may increase bleeding risk.

Use with caution

  • Antifungal agents such as ketoconazole can raise progesterone concentrations.
  • Certain antiepileptic drugs (phenytoin, phenobarbital) may alter hormone metabolism.
  • Hormonal contraceptives containing estrogen may enhance progesterone‑related side effects.
  • Herbal supplements like St. John’s wort may affect progesterone metabolism and should be discussed with the prescriber.

Frequently Asked Questions

Gynalven contains micronised progesterone, which acts as a progesterone receptor agonist, binding to progesterone receptors and reproducing the natural hormonal effects of progesterone in target tissues.

Gynalven is taken by mouth in tablet form. The specific dosing schedule should be determined by a qualified healthcare professional based on the individual’s clinical situation.

Healthcare providers may prescribe Gynalven to women who need supplemental progesterone, such as those undergoing assisted reproductive techniques, experiencing luteal‑phase deficiency, or requiring progesterone as part of hormone replacement therapy.

Gynalven is generally not indicated for routine use during pregnancy unless a physician determines a specific therapeutic need. Its safety profile in pregnancy has not been fully established.

Common side effects include nausea, abdominal discomfort, drowsiness, fatigue, breast tenderness, headache, and occasional dizziness.

Serious reactions, although rare, can include allergic responses (rash, swelling of the face or lips), signs of blood clot formation (leg pain, swelling, shortness of breath), and severe mood changes such as depression.

Precautions include evaluating a history of clotting disorders, liver disease, hormone‑sensitive cancers, uncontrolled hypertension, mood disorders, pregnancy status, and any known hypersensitivity to progesterone or tablet excipients.

Strong CYP3A4 inducers such as rifampin or carbamazepine should be avoided because they can lower progesterone levels, and concurrent use with anticoagulants may increase bleeding risk.

When combined with estrogen‑containing contraceptives, progesterone‑related side effects such as breast tenderness or mood changes may be enhanced, so clinicians often monitor the patient closely.

Gynalven is a prescription‑only medication in the European Union and can be obtained through a licensed physician or specialist who can assess the need for progesterone therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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