Giane

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Medically reviewed

Marina Burgos

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 Giane

Property Description
Active Ingredients Cyproterone acetate, Ethinylestradiol
Form Oral Tablets
Pharmacological Class Antiandrogen-Estrogen Combination
Origin Synthetic (Steroid derivatives)
Type Combination Product

What Type of Medicine is Giane? (Definition and Classification)

Giane is a prescription-only combined oral hormonal preparation classified as an Antiandrogen-Estrogen combination. This medicine, also known generically as Co-cyprindiol, is fundamentally composed of two synthetic active compounds administered orally in the form of tablets. Its pharmacological identity is defined by its inclusion in the Anatomical Therapeutic Chemical (ATC) system under the group G03HB01, designating it as an antiandrogen combined with an estrogen.

The drug entity, containing Cyproterone acetate and Ethinylestradiol, distinguishes itself from standard hormonal preparations due to the potent antiandrogenic activity of the Cyproterone acetate component. The formulation is widely recognized in numerous global markets under similar generic compositions, indicating a uniform medical identity supported by international consensus. This combination is clinically recognized for its effectiveness in counteracting the visible and underlying effects of excess male hormones.


Composition and Hormonal Role (Ingredients and Form)

The medicine consists of the active ingredients Cyproterone acetate and Ethinylestradiol, which are combined with solid pharmaceutical excipients to form the final oral tablets. Cyproterone acetate serves the function of a progestogen while acting as the key antiandrogen, whereas Ethinylestradiol provides the necessary synthetic estrogen component.

This precise blend of synthetic steroid derivatives ensures that the medicine, administered orally, exerts a necessary hormone-balancing effect. The role of the Ethinylestradiol is crucial as it helps stabilize the hormonal environment and enhances the primary therapeutic action of the Cyproterone acetate, which is designed to specifically address the biological effects of excess male hormones (androgens). This makes the formulation a common choice for managing symptoms like excessive oil production or unwanted hair growth.


Primary Therapeutic Purpose (General Benefit)

The core purpose of Giane is to systematically manage health conditions in women that are caused by an overproduction of androgens or a heightened sensitivity to these hormones. The fundamental mechanism involves implementing a dual physiological action: direct androgen receptor blocking coupled with the suppression of androgen production. By acting directly at the cellular level, this combined hormonal therapy provides a powerful, systematic approach to regulating the hormonal status. The general benefit is centered on controlling the physiological manifestations that result from androgen excess, offering targeted relief via precise hormonal modulation.

Regulatory References

  1. NIH/MedlinePlus

What side effects are possible with Giane?

Possible side effects and safety information for Giane

Official safety documentation for products containing cyproterone acetate and ethinylestradiol (like Giane/Diane-35) highlights specific risks and limitations governing their use, primarily focused on the potential for serious vascular events.


Adverse reaction scope

Classification Detail (as documented in regulatory sources)
Serious Adverse Reactions Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, and arterial thromboembolism (ATE), such as stroke and myocardial infarction. Liver adenomas and carcinomas are also documented post-marketing.
Key System-Organ Class Vascular disorders (thromboembolic events); Neoplasms (liver tumors).
Common Side Effects Nausea, headache, stomach pain, weight increase, breast tenderness/pain, mood changes, and breakthrough bleeding.
Frequency Notes The risk of VTE is considered rare, but is documented to be 1.5 to 2 times higher than for combined oral contraceptives containing levonorgestrel. The highest excess risk of VTE is typically during the first year of use.

Safety Classifications (High-Level)

Safety Monitoring: Regular medical evaluation is explicitly required for users, especially to monitor for signs of thromboembolism and for liver function abnormalities.

Safety-Related Restrictions: The medication is not indicated for use solely as a hormonal contraceptive; rather, it is reserved for the treatment of moderate to severe acne or hirsutism related to hormone sensitivity when alternative treatments have failed. It must be discontinued three to four menstrual cycles after the treated condition has completely resolved to limit total exposure.

Contraindications: Use is restricted in women with a history of thromboembolic disorders, certain severe migraines, uncontrolled hypertension, or liver disease.


Connection to the overall safety profile

Official safety information structures the understanding of risks by emphasizing that the known, rare risk of thromboembolism associated with this combination product is higher than with some other hormonal contraceptives. This heightened risk led governmental regulatory bodies to restrict its approved use to specific, severe androgen-related conditions, requiring that treatment duration be minimized and that the product not be used simply for birth control. Strict monitoring of patients and adherence to contraindications are noted as necessary measures to mitigate these risks.

Overdose and Emergency Response

The official regulatory profile for Giane (Cyproterone acetate and Ethinylestradiol) documents that acute overdose is not likely to be life-threatening. Authorities state that there have been no reports of serious adverse outcomes from overdose of combined hormonal preparations, including ingestion by children.


Documented Overdose Manifestations

The officially documented clinical signs of overdose are typically non-severe. Manifestations may affect multiple physiological systems and include nausea and vomiting, headache, drowsiness, and breast tenderness. A characteristic effect is heavy vaginal bleeding (or uterine bleeding), which is documented to occur 2 to 7 days following the overdose. Other documented symptoms include rash and discolored urine.

Required Emergency Actions and Management

When a Giane overdose is suspected, official government guidance mandates that individuals seek medical help right away. The required immediate action is to call poison control. Medical management is strictly defined as symptomatic treatment and supportive care, consistent with the low acute toxicity profile. Procedures in an emergency setting may include running blood and urine tests and monitoring of vital signs (e.g., temperature, pulse, and blood pressure) until the documented symptoms subside.

Therapeutic Uses of Giane

What Giane Treats: Main Uses and Benefits

Giane is a combined hormonal preparation relevant for easing the symptoms that occur in women of reproductive age when their bodies react to androgen sensitivity. It is applied in settings where alternative treatment approaches have not provided sufficient symptomatic support.

This medicine is considered relevant for easing certain androgen-related conditions.

The primary therapeutic focus is commonly used to help with symptoms related to systemic imbalance, including moderate to severe acne and hirsutism (unwanted hair growth). This approach is applied in addressing Polycystic Ovary Syndrome (PCOS)-related skin and hair symptoms. The overall benefit contributes to easing the physical discomfort and visible impact of chronic blemishes and hair growth.


Focus on Symptom Relief

This medication may assist with managing pronounced symptoms of severe acne, seborrhea, and hirsutism, providing supportive relief when these symptoms become more noticeable.

Regulatory References

  1. European Medicines Agency referral decision

Eligibility and Restrictions for Use

The medicine is strictly limited to women of reproductive age and is only allowed when standard initial treatments for the condition (such as topical therapy or systemic antibiotics) have failed. Use is not recommended for girls who have not yet reached menarche.

The use of Giane is contraindicated for several populations. Absolute prohibitions include a personal or family history of venous or arterial thrombotic events (e.g., deep vein thrombosis, stroke, myocardial infarction) or any inherited thrombophilia (clotting disorder). It is also strictly prohibited for smokers aged over 35 years.

Further contraindications apply to women with active severe liver disease, liver tumors, or known or suspected estrogen-sensitive malignancies, such as breast carcinoma. Women experiencing migraine with focal neurological symptoms must not use this medicine. Concomitant use with any other hormonal contraceptive is also prohibited.

Regarding physiological status, Giane is contraindicated during both known or suspected pregnancy and breastfeeding. Additionally, regulatory rules mandate that Giane must not be used solely for contraception and must be discontinued at least four weeks before any planned major surgery.

What should I know about interactions with other medicines?

Co-administration of Giane with other hormonal contraceptives is strictly contraindicated to prevent excessive hormone exposure. The medicine is also contraindicated with specific combination Hepatitis C regimens, such as those containing Ombitasvir/Paritaprevir/Ritonavir, due to the regulatory-defined risk of liver enzyme elevations. The official profile defines interactions primarily through pharmacokinetic changes.

Enzyme-inducing substances, including certain anticonvulsants (e.g., Carbamazepine, Phenytoin) and the herbal product St. John’s Wort, are documented to decrease the plasma concentration of Giane’s components, which can reduce efficacy. Conversely, enzyme-inhibiting substances (e.g., certain Macrolide antibiotics or Amiodarone) may increase exposure.

Pharmacodynamic interactions are also noted: Giane may decrease the therapeutic effect of antidiabetic agents (like Insulin) and diminish the serum concentration of Lamotrigine. Furthermore, Giane can speed up or slow down the removal of other medications, including corticosteroids.

A mandatory timing restriction requires the medicine be stopped at least four weeks before major elective surgery and not restarted until two weeks after full ambulation to mitigate the risk of venous thromboembolism. This official profile strictly outlines mandated restrictions and exposure modifications as defined by regulatory authorities.

Mechanism of Action

Blockade of Hormone Receptors

This domain covers the direct, peripheral action of Giane, where one component acts as an androgen receptor antagonist to block receptor sites on target cells, such as those in the skin. By preventing androgens from initiating a signal, this mechanism initiates a change in signaling at the receptor, which results in reduced stimulation of oil-producing glands and other androgen-sensitive structures.

Suppression of Hormone Production

This is the central action of the drug, engaging the Hypothalamic-Pituitary-Ovarian (HPO) axis via negative feedback. The active components signal the pituitary gland to reduce the output of gonadotropins, which subsequently lowers the systemic production of androgens by the ovaries. This mechanism acts to reduce the systemic concentration of androgens within the body.

Modulation of Hormone Availability

Giane also influences how hormones travel in the blood by inducing the production of Sex Hormone-Binding Globulin (SHBG) in the liver. An increase in SHBG results in more androgens being bound and inactivated while circulating, thereby modulating the fraction of biologically "free" hormone available to trigger cellular responses. The convergence of these mechanisms (receptor blockade, production suppression, and binding modulation) defines the drug's overall physiological effect.

Dosage and Administration Information

How Giane is Used

Giane is an oral tablet containing a fixed dose of 2 mg Cyproterone acetate and 0.035 mg Ethinylestradiol, and its use is strictly guided by a cyclical, non-titratable regimen. The administration must adhere to a precise 28-day schedule to establish and maintain the intended use pattern.


Administration and Frequency Principles

The standard regimen involves taking one active tablet daily for 21 consecutive days. Tablets must be swallowed with some liquid and administered at the same time each day to ensure consistent hormonal presence. The 21-day period is followed by a 7-day tablet-free interval. The new 21-day course is initiated after the seven tablet-free days are complete, regardless of whether the withdrawal bleed has ended. Treatment typically begins on Day 1 of the menstrual cycle, corresponding to the first day of menses, or according to specific post-partum or post-abortion instructions provided in the prescribing information.


Course Duration and Procedural Rules

Treatment with Giane is used for several months, as clinical improvement in androgen-related symptoms may require continuous intake for at least three months before full effect is observed. Discontinuation should generally occur 3 to 4 cycles after the clinical signs of the underlying condition have fully resolved. A key procedural restriction is that patients using this medicine must not use any additional hormonal contraceptive concurrently.

If a dose is missed by less than 12 hours, it should be taken immediately to maintain efficacy. If the delay exceeds 12 hours, the missed tablet is omitted, and the remainder of the pack is continued at the regular time, while an auxiliary non-hormonal method of contraception must be implemented for the next seven days of active tablet use.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Giane

Evidence for Use in Androgen-Sensitive Acne

Research exploring how symptoms change over time for acne primarily involves Randomized Controlled Trials (RCTs). These studies typically included women of reproductive age who had previously found other standard acne treatments to be insufficient. The trials describe symptom patterns observed over defined time intervals, most often focusing on short- to intermediate-term observation periods of 3 to 12 months. The research describes measurements taken of severity scores and lesion counts, and also monitored changes in Sex Hormone-Binding Globulin (SHBG) and circulating androgen levels. Evidence is limited for long-term outcomes, and the status of acne symptoms beyond 12 months of continuous use is not well characterized.


Evidence for Use in Hirsutism (Unwanted Hair Growth)

Research exploring changes in hirsutism included women of reproductive age, including those with Polycystic Ovary Syndrome (PCOS). This research examined outcomes using standardized clinical assessment tools, such as the Ferriman-Gallwey Score (F-G Score). Studies report that measurements of the F-G Score differed in the studied populations; researchers documented that these changes often required a long observation period of at least 6 to 12 months. Findings describe patterns observed where changes in SHBG and circulating androgen levels occurred throughout the observation periods.


Study Design, Limitations, and Uncertainty

Studies were designed to include participants who had already tried and not fully responded to a first-line therapy, meaning the results apply only to the populations studied. Comparative research often studies explored Giane by comparing it against placebo or other hormonal therapies. Reviewers note that evidence quality varies across studies, sample sizes were modest in some analyses, and comparative evidence is lacking for certain alternative therapies. Overall, the existing studies provide context but not individual predictions, and certainty remains low for some long-term outcomes.

Frequently Asked Questions (FAQ)

Common questions about Giane (FAQ)

Q: What is Giane officially prescribed to treat?

A: According to regulatory documents, Giane is officially prescribed to treat moderate to severe acne or excessive hair growth (hirsutism) in women. It is reserved for these conditions when other first-line treatments have not provided sufficient results. The medicine is used to manage symptoms caused by the body's sensitivity to male hormones (androgens).


Q: Does Giane have any approved uses beyond its primary condition?

A: Official product information indicates that Giane is approved for severe androgen-related skin conditions. It is specifically not indicated for use only as a birth control pill. The medicine is reserved only for therapeutic use when alternative treatments have been unsuccessful.


Q: How long does it usually take for Giane to start showing an effect?

A: Studies and official information indicate that the time to initial benefit varies by condition. For acne, visible improvement is often observed after the first three months of continuous use. Treating hirsutism usually requires a longer period, with clinical improvement typically seen after six months or more of continuous intake.


Q: Are there any specific supplements or vitamins that should be avoided when using Giane?

A: According to the official product information, the herbal product St. John’s Wort (Hypericum perforatum) is documented to reduce the concentration of Giane's components in the blood. This reduction may lead to decreased effectiveness. Regulatory guidance suggests discussing the use of any supplements or herbal products with a healthcare provider.


Q: Does Giane have a known interaction with alcohol?

A: Official product information reports a minor interaction between the medicine's estrogen component (Ethinylestradiol) and alcohol. Regulatory guidance suggests that individuals discuss their alcohol intake with a healthcare provider.


Q: Do the side effects of Giane typically subside after the first few weeks?

A: Regulatory patient information indicates that some common side effects may resolve as the body adapts to the medicine. This adjustment usually occurs during the first few cycles of use.


Q: Is Giane appropriate for people with a history of liver or kidney issues?

A: The medicine is officially contraindicated (prohibited) for women who have active severe liver disease or liver tumors, as it can affect liver function. Regulatory guidance recommends regular monitoring for liver function abnormalities. The regulatory text does not generally list non-severe kidney issues as an absolute prohibition.


Q: Is Giane approved for use in elderly patients?

A: Regulatory documents state that Giane is not approved for use in women who are going through or have completed menopause. Its use is strictly limited to women of reproductive age.


Q: Is Giane considered a new pharmaceutical product or an established one?

A: The formulation combines well-established hormonal components that have been in use for several decades. The combination product itself has been widely available and recognized under various brand names in numerous global markets.


Q: Does Giane affect the ability to drive or operate machinery?

A: Official product information notes that one of the active components may cause some users to feel drowsy, dizzy, or less alert. Official information advises caution when operating machinery or driving until the medicine’s effects are known.


Q: Why do patients sometimes discontinue treatment with Giane?

A: Official guidance recommends discontinuing the medicine after the underlying condition has resolved to limit total exposure. However, patients may also choose to stop treatment due to experiencing adverse effects, such as nausea, headaches, or mood changes, that are described in the safety information.


Q: What are the general signs that indicate Giane may not be providing the expected benefit?

A: Studies and official information indicate that the general sign of inadequate benefit is the absence of the expected clinical improvement over the typical treatment duration. This would be no visible change in acne after three months or no improvement in hirsutism after six months.


Q: Is it normal to feel a change in appetite when starting Giane?

A: Regulatory documentation lists weight increase as a common side effect of the medicine. A change in appetite may be experienced as a result of the common hormonal adjustments that occur when beginning treatment.


Q: Does Giane carry a Boxed Warning (Black Box Warning) in the official prescribing information?

A: The medicine's international regulatory information carries a prominent warning emphasizing the rare but serious risk of venous thromboembolism (VTE), which involves blood clots. The risk is documented as being higher than with some other hormonal contraceptives.


Q: What are the main components of Giane that are inactive (excipients)?

A: The main inactive components, also called excipients, include lactose monohydrate and sucrose. A complete list of all inactive ingredients used to form the tablet is provided in the official patient information leaflet.


Q: How is Giane eliminated from the body?

A: According to official pharmacokinetic studies, the active ingredient, Cyproterone acetate, is eliminated from the body primarily through the feces (stool) and to a lesser extent through the urine.


Q: Does Giane have any known effects on fertility in men or women?

A: The medicine works by causing a reversible inhibition of ovulation, which temporarily prevents the ability to become pregnant while in use. Normal fertility is generally expected to return after treatment with Giane is discontinued.


Q: Is Giane known to interact with common dietary beverages like grapefruit juice?

A: Grapefruit juice has been noted in studies to potentially increase the concentration of the estrogen component in the bloodstream. This effect may increase the risk of side effects. Official information advises caution, and individuals should discuss dietary concerns with a healthcare provider.

How should Giane be stored and disposed of?

The storage and disposal of Giane (cyproterone acetate/ethinyl estradiol) must follow the official requirements listed in the medicine's regulatory labeling.

Storage & Disposal Scope

Requirement Official Regulatory Statement
Labeled storage temperature Store the tablets below 25 C
Light/moisture protection Keep in the original blister pack
Packaging-related storage Store in the original container until use
Child-protection storage Keep out of the sight and reach of children
Disposal instructions Return unused or expired medicine to a pharmacist or follow local pharmaceutical waste regulations

Official regulatory documents establish that the product must be stored under temperature control to maintain ingredient stability and must be secured from children. Tablets must remain protected in their original container, and disposal of any unused or expired product is directed via a pharmacist to ensure proper environmental and pharmaceutical waste handling.

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

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