A Milestone Moment: FDA Approves Addyi® for Hypoactive Sexual Desire Disorder in Postmenopausal Women
December 17, 2025
Brand Name :
N/A
Synonyms :
gestodene
Class :
Oestrogens and Progesterones
Dosage Forms & Strengths
Tablet
25 mcg
50 mcg
Take a dose of 75 mcg orally daily in monophasic preparations
Take a dose of 50 to 100 mcg orally daily in triphasic preparations
Not determined
Refer to adult dosing
alpelisib: it may increase the metabolism of gestodene
alprazolam: it may decrease the metabolism of gestodene
alteplase: it may increase the risk of adverse effects with gestodene
amiodarone: it may decrease the metabolism of gestodene
amitriptyline: it may decrease the metabolism of gestodene
betrixaban: it may increase the risk of adverse effects with gestodene
bexarotene: it may decrease the therapeutic efficacy of gestodene
boceprevir: it may increase the serum concentration of gestodene
chlorpromazine: it may increase the metabolism of gestodene
cilostazol: it may increase the serum concentration of gestodene
ciprofloxacin: it may decrease the metabolism of gestodene
domperidone: it may decrease the metabolism of gestodene
doravirine: it may decrease the metabolism of gestodene
doxycycline: it may decrease the serum concentration of gestodene
Actions and Spectrum
gestodene exerts its contraceptive action by inhibiting ovulation. It suppresses the release of an egg from the ovaries.
gestodene is a potent progestin and it replicates the actions of the body’s own progesterone hormone.
Frequency not defined
GI disturbances
Changes in appetite
Fluid retention
Oedema
Acne
Allergic skin rashes
Urticaria
Mental depression
Breast changes
Changes in libido
Hair loss
Hirsutism
Fatigue
Drowsiness or insomnia
Fever
Headache
Black Box Warning
None
Contraindication/Caution:
Contraindication:
Caution:
Pregnancy consideration:
Pregnancy category: N/A
Lactation: Excretion into human milk is unknown
Pregnancy Categories:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology
gestodene suppresses ovulation, preventing the release of an egg from the ovaries.
It thickens cervical mucus, making it more difficult for sperm to penetrate the cervix and reach the egg.
Pharmacodynamics
gestodene inhibits the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus.
It reduces the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland.
Pharmacokinetics
Absorption
gestodene is absorbed from the gastrointestinal tract after oral intake.
Distribution
gestodene is distributed to various tissues.
Metabolism
gestodene is metabolized in the liver by various enzymatic processes.
Elimination and excretion
gestodene is excreted from the body primarily through urine and feces.
Administration
gestodene is administered in the form of combined oral contraceptive (COC) pills.
Patient information leaflet
Generic Name: gestodene
Why do we use gestodene?
gestodene is used as a component of combined oral contraceptive (COC) pills. When combined with an estrogen it helps prevent pregnancy. COC pills containing gestodene used to regulate the menstrual cycle and reduce menstrual bleeding.