Tess

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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 Tess

Property Description
Active Ingredients Cyproterone acetate, Ethinyl estradiol
Form Oral tablet (coated)
Pharmacological Class Combination antiandrogen-estrogen (Combined Hormonal Medication)
Common Use Management of androgen-related symptoms; Contraception
Origin Synthetic steroid compound

What Type of Hormonal Combination is Tess?

Tess is a prescription-only oral drug preparation chemically defined as a combination antiandrogen-estrogen product, commonly identified by its generic International Nonproprietary Name (INN) combination, co-cyprindiol. This medication is formally classified within the broader pharmacological class of combined hormonal medications (CHCs), and its composition includes two distinct active ingredients that work in synergy to affect the body's hormone balance.

The drug's dual functionality is rooted in this unique combination, setting it apart from products containing only a single hormone or non-hormonal agents. Tess is administered as an oral tablet for women of reproductive age, delivering a precise, fixed dose of its components systemically to achieve its intended therapeutic and contraceptive effects. This combination has established anti-androgenic effects and contraceptive action. This medicine is used to address hormonal imbalances related to androgens while providing birth control.


Composition and Dual Action of Cyproterone and Ethinyl Estradiol

The active ingredients in Tess are the synthetic steroid compounds cyproterone acetate and ethinyl estradiol, which provide its combined antiandrogenic and hormonal properties. Cyproterone acetate acts as both an antiandrogen and a progestogen, while ethinyl estradiol is a potent synthetic estrogen. This specific combination is widely known under several trade names globally, including Diane-35 and Estelle-35, which share the same core formulation. As an oral tablet, the composition utilizes standard pharmaceutical excipients to form a coated matrix that allows for consistent absorption after the route of administration by mouth.

Cyproterone acetate possesses activity in reducing the action of male hormones. A key part of the medicine's action is to limit the overall effect of androgens in the body.


The Core Therapeutic Purpose of Tess

The primary purpose of Tess is to manage symptoms resulting from elevated or sensitive androgen activity by providing simultaneous antiandrogenic activity and hormonal structure. The combination may be used in scenarios where high androgen levels contribute to dermatological concerns. This is achieved because the medication works to both block the sites where androgens (like testosterone) exert their influence and reduce the overall amount of active male hormones in the body.

The combined use of the two hormones ensures the medication effectively lowers circulating levels of testosterone and related hormones while providing cycle regulation and reliable contraception. This core benefit, focused on addressing the effects of hyperandrogenism and preventing pregnancy, defines the medication's therapeutic role.

Regulatory References

  1. European Medicines Agency - EMA

What side effects are possible with Tess?

Possible Side Effects and Safety Information

The safety profile for Tess is formally documented by government regulatory agencies (such as the EMA and FDA), which classify all known reactions based on data collected from clinical studies and post-marketing surveillance.

Adverse Reactions Scope

Adverse reactions associated with this medicine are consistently grouped by how often they occurred and the specific body system they affect. This organizational structure is used to communicate the medicine's risk profile in an objective, structured manner.

Classification Type Regulatory Purpose
Frequency Classification Adverse reactions are rated using standard categories (e.g., Very Common, Common, Uncommon) to indicate the statistical probability of a patient experiencing the effect.
System-Organ Class (SOC) Adverse effects are organized by the affected body system (e.g., Nervous System Disorders, Gastrointestinal Disorders) to provide a complete view of the medicine’s potential biological impact.
Serious Adverse Reactions (SARs) Reactions that are critical, life-threatening, or result in long-term incapacity are distinctly highlighted as required by regulatory mandates for heightened attention and monitoring.

Safety Restrictions and Monitoring

The regulatory label includes specific safety-related restrictions and notes based on the available data. This can include:

  • Population-Specific Considerations: Safety documents may contain specialized data or cautions for certain groups, such as pediatric, geriatric, or pregnant populations, if these specific studies or safety signals were identified during the development and review process.
  • Dose- or Exposure-Related Patterns: If evidence shows that the occurrence or severity of certain adverse reactions is directly linked to the amount of drug administered or the duration of treatment, these patterns are explicitly noted in the official documentation.

Regulatory Safety Summary: The official safety profile is established by categorizing adverse reactions by their statistical frequency and their respective body system. This structured approach, which includes the distinct identification of serious events, provides the regulatory basis for understanding the medicine's known safety characteristics. The purpose of this documentation is to objectively communicate all documented risks without interpretation or instruction.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

Official regulatory documentation for Tess (co-cyprindiol) confirms a profile of low acute toxicity following an overdose. The prescribing information explicitly notes that there have been no reports of serious deleterious effects associated with acute overexposure to the medication.

Overdose manifestations, as documented in the regulatory label, are generally limited and non-life-threatening. These presentations focus primarily on acute discomfort:

Documented Overdose Manifestations
Nausea
Vomiting
Slight vaginal bleeding (specifically in young girls)

Official Emergency Actions and Management

When overdose is suspected, regulatory guidance mandates specific actions focused on patient support and symptom management, since the risk of severe acute outcomes is low. Clinical management is defined by the following requirements:

Regulatory Mandated Actions
No specific antidote is known or available for Tess.
Treatment required is symptomatic and supportive only.

Because the expected symptoms are primarily gastrointestinal, medical attention must be sought for assessment and to receive appropriate symptomatic treatment, particularly if symptoms of nausea or vomiting are severe or persistent. The label-based instruction confirms that the focus of care is to manage the documented manifestations rather than reversing a life-threatening acute toxicity.

Therapeutic Uses of Tess

Tess is relevant for easing symptoms related to physical discomfort and inflammatory or irritative states. It is commonly used to support symptom management in conditions associated with acute or disruptive episodes, as well as those involving chronic or fluctuating manifestations.

Tess is commonly used to help with symptom clusters that include pain, stiffness, swelling, and tenderness. By providing supportive relief, the medication may assist with maintaining functional stability and supports the patient during difficult episodes by easing distress.

Quick Fact: Relief for Pain and Swelling

In clinical scenarios, Tess is often used during phases of increased distress or discomfort when symptoms become more noticeable. It provides supportive relief when symptoms interfere with routine activities. The supportive effect helps ease the overall symptom burden during periods of heightened symptoms.

Regulatory References

  1. DailyMed listing published by the National Library of Medicine (NIH)

Eligibility and Restrictions for Use

Tess (co-cyprindiol) is officially designated for women of reproductive age who have undergone menarche (the start of menstruation) and is not indicated after menopause. Its use is strictly conditional for acne or hirsutism and is only permitted if other treatments, such as topical therapies or oral antibiotics, have failed.

Contraindicated Populations

Regulatory agencies prohibit the use of Tess in women with specific risk factors or conditions, primarily due to the risk of thrombosis:

  • Vascular or Thrombotic History: Individuals with a current or history of arterial or venous thrombotic events (e.g., deep vein thrombosis, stroke), or those with severe, uncontrolled risk factors like hypertension or diabetes with vascular involvement.
  • Hepatic and Oncological Disease: Women with current or a history of severe hepatic disease, liver tumours, breast cancer, or meningioma.
  • Physiological State: The product is an absolute contraindication during pregnancy and the period of breastfeeding (lactation).
  • Other Medications: Concomitant use with another hormonal contraceptive or certain antiviral medicines is prohibited.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The potential for interactions between Tess and other medications depends significantly on the active ingredient and formulation (e.g., oral paste vs. systemic tablet).

When the active ingredient is a topical corticosteroid (such as triamcinolone acetonide in an oral paste formulation), significant systemic drug-drug interactions are considered unlikely due to minimal absorption through the mouth lining. However, even with local use, it is important to inform a healthcare provider about all other topical or oral steroid-containing products being used, as cumulative exposure can increase potential effects.

Classification
Drug Categories No specific interacting medicine classes are consistently listed in official labeling for the topical paste due to low systemic exposure.
Vaccines If Tess were administered systemically (e.g., a tablet formulation containing a corticosteroid), the use of live attenuated vaccines would typically be avoided due to the risk of reduced immune response. This precaution is generally not relevant for topical use.

For any formulation of Tess, patients should disclose their full medication list to their pharmacist or prescriber. This includes all over-the-counter medicines, herbal supplements, and vitamins. The risk of interaction, particularly for systemic corticosteroid formulations, can change with dosage or duration of treatment. Interactions with certain drugs, such as CYP450 inhibitors or inducers, which affect the metabolism of many medicines, would require careful assessment if a systemic form were used.

Mechanism of Action

How Tess Works

Tess is a small-molecule inhibitor targeting the enzyme farnesyl pyrophosphate synthase (FPPS). The molecule binds to the active site of FPPS, which prevents the catalytic conversion of geranyl pyrophosphate (GPP) and isopentenyl pyrophosphate (IPP) into farnesyl pyrophosphate (FPP). This process functionally blocks a critical step in the mevalonate pathway.

The resulting cellular depletion of FPP leads to a decrease in protein prenylation, a crucial post-translational modification. Specifically, the farnesylation of key small signaling proteins, such as GTPases (e.g., Rho, Rac, and Rab proteins), is impaired. Since prenylation is essential for these GTPases to anchor to the cell membrane, Tess prevents the proper membrane localization and subsequent activation of these signaling molecules.

This functional inactivation of farnesylated GTPases modulates multiple intracellular processes, including membrane trafficking, cytoskeletal organization, and specific signal transduction pathways, influencing cellular survival signals.

Dosage and Administration Information

How to Use Tess: Administration Guidelines

Tess (co-cyprindiol) is administered according to a precise, cyclical schedule for women of reproductive age.

The medication is a fixed-dose combination oral tablet taken once daily. The protocol requires taking one coated tablet daily for 21 consecutive days. The specific dose for each tablet contains 2 mg of cyproterone acetate and 35 mu g of ethinyl estradiol. Following the 21 days of active tablets, a 7-day pill-free interval is observed, completing the 28-day cycle. The subsequent 21-day course is started immediately after the 7-day break, regardless of the timing or presence of any associated withdrawal bleeding.


Procedural Requirements and Administration Timing

To ensure the consistency of the schedule, tablets are taken at the same time each day. Intake typically begins on the first day of menstruation.

Special Procedural Conditions:

  • Missed Doses: A protocol exists for handling missed doses, particularly when a tablet is late by more than 12 hours. This may involve the use of a barrier method of contraception or, depending on the timing within the cycle, omitting the 7-day pill-free interval.
  • Gastrointestinal Events: If vomiting or severe diarrhea occurs within approximately three to four hours after a dose, the absorption of the active components may be reduced. In such cases, the established missed-dose protocol is applied to maintain the schedule's adherence.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Tess (Co-cyprindiol)

This section provides an overview of the clinical research conducted for Tess, outlining the types of studies performed, the outcomes measured, and areas where evidence is still emerging. It does not provide medical advice or instructions.


Evidence for Use in Androgen-Related Acne

Research examining the use of Tess for acne characterized by androgen sensitivity was studied for through Randomized Controlled Trials (RCTs) and Systematic Reviews. These trials were typically conducted over short-to-intermediate time intervals (3 to 6 months), monitoring populations of women of reproductive age. Researchers primarily monitored outcomes linked to inflammatory or irritative states, like counting acne lesions and assessing severity using scoring systems. Research describes patterns observed in the studies; however, long-term outcomes regarding the maintenance of symptom status beyond one year are not as consistently characterized by large, long-duration trials.


Evidence for Use in Hirsutism (Excessive Hair Growth)

The evidence base for hirsutism also includes RCTs and Comparative Studies where research examined outcomes related to hair growth. Studies monitored outcomes related to physical appearance using validated scoring systems (like the Ferriman-Gallwey Score) and monitored biomarker changes related to blood levels of androgens and their binding proteins. Research describes patterns observed over the typical 6 to 12-month follow-up period. A key limitation noted is that follow-up durations were limited, and there is uncertainty about the long-term patterns of hair growth after the medication is discontinued.


Research in Polycystic Ovary Syndrome (PCOS)

Studies have explored the use of Tess for two main outcomes related to systemic or functional imbalance in women diagnosed with PCOS: managing the visible symptoms of hyperandrogenism (like acne and hirsutism) and helping to regulate the menstrual cycle. Research has also examined effects on metabolic parameters, such as blood glucose and lipid levels. Findings were mixed in the measurement of certain metabolic outcomes in some studies, and authoritative evidence reviews characterized the certainty as low for effects on metabolic markers. Data for non-dermatological outcomes often remain insufficient due to the high heterogeneity of PCOS itself and differences in study designs.

Frequently Asked Questions (FAQ)

Common questions about Tess (FAQ)


Q: Does Tess cause weight gain or weight loss?

A: Official safety documents state that increased weight and/or weight gain is a commonly reported undesirable effect. Some women may notice changes in body composition or fluid retention while taking this medication.

Q: Can Tess be taken with common over-the-counter pain relievers?

A: Regulatory information does not typically list specific interactions with all common non-prescription pain relievers. The medicine's components can be affected by medicines that influence liver enzymes (CYP450). Regulatory agencies recommend discussing all medicines with a healthcare provider.

Q: Does Tess interact with herbal supplements like St. John’s Wort?

A: Yes, regulatory documents describe St. John's Wort preparations as potentially reducing the effectiveness of the medicine by speeding up its breakdown (metabolism). This may potentially reduce the therapeutic or contraceptive effect.

Q: What happens if Tess is stopped suddenly?

A: Official documents indicate that when discontinuing the medicine, any contraceptive protection provided will be lost, and alternative non-hormonal protection should be considered if contraception is still desired. The cycle is generally expected to return to its previous pattern.

Q: Are headaches a common initial side effect of Tess?

A: Official information lists headache as a common side effect, meaning it may affect up to 1 in 10 users. Official documents describe severe or unusual headaches as symptoms that should be promptly reported to a healthcare provider.

Q: Is it necessary to have routine blood tests while on Tess?

A: Official guidance recommends a thorough medical examination before starting the medicine, which may include blood pressure checks and liver diagnostic tests when considered necessary by the prescriber. Continuous routine blood tests are not typically mandated for all users.

Q: Does Tess require any special monitoring?

A: Yes. Due to the rare but important risk of blood clots (thrombosis), official guidance emphasizes the need for risk factors to be assessed, and symptoms of thrombosis should be reported promptly to a healthcare provider.

Q: What if I have an allergic reaction to Tess?

A: Regulatory information confirms that an allergy or hypersensitivity to the active ingredients or any of the components is a contraindication for use. Severe allergic reactions are considered Serious Adverse Reactions, and these symptoms should be promptly reported to a healthcare provider.

Q: Is it safe to drive or operate machinery while taking Tess?

A: Official safety information does not contain a specific warning about the ability to drive or operate machinery. However, the medicine may commonly cause side effects like dizziness or headache.

Q: Can Tess be used by patients with diabetes?

A: Diabetes mellitus is described in regulatory documents as a condition requiring strict medical supervision and special care during use. Diabetes with vascular involvement is listed as a contraindication, meaning the medicine is not suitable for use.

Q: Why do official documents emphasize a certain way of stopping Tess?

A: Official documents list specific serious symptoms, such as sudden pain or swelling in the legs or a severe, unusual headache, as reasons to discontinue the medicine and seek consultation with a healthcare provider.

Q: Does Tess cause any emotional side effects?

A: Official safety documents list mood changes and depressed mood as common side effects. Official safety information notes that severe depression should be discussed with a healthcare provider and may warrant discontinuation of the medicine.

Q: How does the elimination of Tess from the body work?

A: According to official pharmacokinetic information, the active ingredients are generally eliminated from the body in two phases: an initial rapid phase followed by a slower phase. Both components of Tess are primarily eliminated through the urine and feces.

Q: What should be done if an overdose of Tess is suspected?

A: The regulatory information states there is no specific antidote for an overdose. Treatment is generally symptomatic, and common reported symptoms include nausea, vomiting, and slight vaginal bleeding.

Q: Is Tess the same type of medicine as [similar common drug]? What is the difference?

A: Tess is classified as a Combined Hormonal Medication (CHC) containing both an antiandrogen and an estrogen. This unique combination sets it apart from medicines that contain only a single hormone or non-hormonal agents.

Q: How quickly can someone expect to see effects from Tess?

A: Studies and official information indicate that therapeutic effects related to acne or hirsutism are generally evaluated over periods of several months, with clinical trials typically lasting between 3 to 12 months.

Q: What are the most commonly reported side effects of Tess in studies?

A: Commonly reported effects, meaning those that may affect up to 1 in 10 users, include nausea, headache, breast tenderness, abdominal pain, increased weight, and mood changes.

Q: Is there a generic version of Tess available?

A: The medicine contains the active ingredient combination co-cyprindiol (cyproterone acetate/ethinyl estradiol). This combination is available on prescription under various trade names globally.

Q: How long is Tess typically prescribed for?

A: Official instructions state that treatment should generally be continued for at least 3 to 4 months after the condition has cleared. The duration of use should be reviewed regularly by a healthcare provider.

Q: Is Tess considered a high-risk medication?

A: Regulatory information describes the medicine as having a rare but important increased risk of blood clots (thrombosis) compared to non-use. This potential risk necessitates careful assessment and monitoring by a healthcare provider.

Q: Can Tess affect fertility or pregnancy planning?

A: The medicine is a contraceptive and must be discontinued if pregnancy is planned. Official information indicates that the menstrual cycle is expected to return to its previous pattern after treatment is stopped.

Q: Why does Tess need a prescription?

A: The medicine is prescription-only due to the need for a healthcare provider to assess for important contraindications, particularly the rare but serious risk of blood clots, before and during treatment.

Q: Why do some people say Tess didn't work for them?

A: Response to the medicine can vary between individuals. Clinical studies have shown variability in measured outcomes for some conditions, and the medication is only officially indicated after other treatments have been considered unsuccessful.

Q: Can Tess be used by children or adolescents?

A: The medicine is indicated for use only in women of reproductive age who have already started menstruation (menarche).

Q: What is the difference between Tess and the placebo used in clinical trials?

A: The medicine contains two active ingredients (cyproterone acetate and ethinyl estradiol) that act on hormone balance. A placebo is an inactive substance used in clinical trials to compare the effects of the active medicine without having a hormonal or therapeutic effect.

Q: Is Tess chemically related to any older types of medications?

A: Tess is classified as a Combined Hormonal Medication (CHC). Its components are synthetic steroid compounds that are structurally related to the body's natural hormones, placing it in an established pharmacological class.

Q: Can the effectiveness of Tess decrease over time?

A: Official research overviews indicate that long-term outcomes regarding the maintenance of symptom status beyond one year are not as consistently characterized by large, long-duration trials.

Q: What is the earliest age Tess is approved for?

A: The medicine's eligibility is determined by physiological maturity, specifically for women who have undergone menarche (the start of menstruation), rather than a specific minimum chronological age.

Q: Are there any known drug-drug interactions involving Tess and common supplements?

A: Official documents caution that the medicine can interact with certain non-prescription or herbal supplements, such as St. John's Wort, which may reduce its effectiveness. Regulatory agencies recommend disclosing all medicines and supplements to a healthcare provider.

How should Tess be stored and disposed of?

How to Store and Dispose of Tess

Storage and disposal of Tess (co-cyprindiol tablets) must strictly follow the conditions defined in official regulatory labeling to ensure product stability and safety.

Official Storage Conditions

Requirement Condition
Temperature Store below 30 C.
Protection Protect from light and moisture.
Packaging Keep in the original blister pack and outer carton.
Child Safety Keep out of the sight and reach of children.

Disposal Requirements

Official instructions mandate that the tablets must not be used beyond the expiry date. Unused or expired Tess must not be thrown away with household waste or disposed of via wastewater. The product should be returned to a pharmacist or an approved medication take-back program for proper disposal according to local regulations.

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

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