Cyclo-Progynova

Quick links to important sections

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 Cyclo-Progynova

Quick Facts

Property Description
Active Ingredients Estradiol valerate, Norgestrel
Form Coated tablets, sequential pack
Pharmacological Class Sequential Hormone Replacement Therapy (HRT)
Common Use Type Hormone supplementation / Substitution therapy
Origin Synthetic sex hormone preparation

Defining Cyclo-Progynova: Classification and Type

Cyclo-Progynova is a combined preparation formally categorized as a Sequential Hormone Replacement Therapy (HRT). It is specifically designated as a hormonal preparation for substitution therapy intended to manage issues linked to the decline in natural hormones.

This oral medicine belongs to the pharmacological group of sex hormone preparations. It uses a sequential regimen, where the active ingredients are administered on a distinct cyclical schedule, a feature that distinguishes it from continuous combined preparations. This approach is recognized for offering a hormone replacement option that mimics natural hormonal rhythm. The preparation is supplied as coated tablets intended for oral administration.


Composition and Preparation: Estradiol Valerate and Norgestrel

Cyclo-Progynova’s core consists of two active ingredients: Estradiol valerate, which acts as the estrogen source, and Norgestrel, which serves as the progestogen source. Both are identified as synthetic sex hormone preparations.

The preparation is formulated in a calendar pack to ensure phased delivery. This estrogen-progestogen combination ensures that the necessary hormonal inputs—both estrogen and progestogen—are supplied in a structured manner, maintaining the integrity of the treatment regimen.


The General Purpose of Sequential Hormone Supplementation

The general purpose of using Cyclo-Progynova is to provide hormone supplementation to the body. Its action is focused on facilitating the replacement of ovarian hormones that are naturally no longer produced at sufficient physiological levels. The structured delivery through the sequential regimen allows for a phased supply of both Estradiol and Norgestrel, aimed at restoring hormonal equilibrium and supporting physiological functions dependent on these principal sex hormones.

Regulatory References

  1. Summary of Product Characteristics (SmPC)

What side effects are possible with Cyclo-Progynova?

Possible Side Effects and Safety Information

The safety profile for Cyclo-Progynova, a sequential Hormone Replacement Therapy (HRT) containing estradiol valerate and norgestrel, is categorized by regulatory bodies based on the frequency and system-organ class of reported events.


Frequency-Classified Adverse Reactions

Adverse reactions are formally listed in official prescribing information according to their incidence:

  • Very Common (ge 1/10): Headache, and breast tenderness or pain.
  • Common (ge 1/100 to < 1/10): Includes depressive mood, dizziness, nausea, abdominal pain, weight changes, and swelling (edema).
  • Uncommon (ge 1/1,000 to < 1/100): Covers events such as hypersensitivity reactions, migraine, visual disturbances, and changes in libido.

These effects are grouped into system-organ classes including Nervous System Disorders, Gastrointestinal Disorders, Metabolism and Nutrition Disorders, and Reproductive System and Breast Disorders.


Serious Adverse Reactions and Safety Constraints

The regulatory label documents risks that are rare but clinically significant. Serious risks associated with HRT include Venous Thromboembolism (VTE), which encompasses deep vein thrombosis and pulmonary embolism, and Arterial Thromboembolic Events, such as myocardial infarction and stroke. The risk of developing certain estrogen-dependent malignancies, including breast cancer and endometrial cancer, is also explicitly noted as being associated with the duration of use.

  • Time-Related Patterns: Adverse effects like breast discomfort are often reported as more frequent during the initial months of treatment. Conversely, the serious risks of thromboembolism and malignancy are associated with long-term exposure.
  • Safety Restrictions: The medicine is formally contraindicated in specific conditions, such as severe active liver disease, a history of VTE, or known or suspected hormone-dependent malignancies. The official labeling mandates regular medical examinations, including blood pressure and breast checks, for individuals using this medicine.

Overdose and Emergency Response

Overdose and When to Seek Help

Official government-authorized labeling provides specific guidance on the potential effects of an accidental or intentional overdose of Cyclo-Progynova.


Documented Overdose Manifestations

Regulatory information indicates that the primary clinical manifestations following an overdosage are generally not considered life-threatening. The documented symptoms relate primarily to the gastrointestinal and reproductive systems.

System Documented Symptoms
Gastrointestinal Nausea, Vomiting
Reproductive Breakthrough bleeding, Withdrawal bleeding

Emergency Actions and Treatment

Regardless of the severity of initial symptoms, official health guidance mandates seeking immediate medical attention following any suspected overdosage. Prompt consultation with emergency services or a Poison Control Center is required.

Regulatory documents explicitly state that there is no specific antidote available for an overdose of this medication. Consequently, the required treatment approach is symptomatic; medical professionals focus on managing the presenting symptoms.

Summary

The officially documented overdose profile is characterized by common symptoms like nausea, vomiting, and unexpected bleeding. Although the outcome is typically not severe, it is a regulatory requirement that patients or caregivers seek emergency medical treatment immediately to ensure proper assessment and care.

Therapeutic Uses of Cyclo-Progynova

What Cyclo-Progynova Treats: Main Uses and Benefits

Cyclo-Progynova is categorized as Sequential Hormone Replacement Therapy (HRT) and is applied in situations involving a deficiency of ovarian sex hormones. Its therapeutic benefit is relevant for easing symptoms related to hormone deficiency states. The medication is commonly used to help with managing symptoms of climacteric syndrome, supporting the management of the long-term risk of postmenopausal osteoporosis, and managing symptoms related to menstrual disorders.


Symptom Management and Benefits

This therapy may assist with managing symptom clusters that have become intense or disruptive to daily functioning. It is applied in addressing challenging vasomotor symptoms such as severe hot flashes and excessive sweating, along with systemic manifestations like sleep disturbances and nervous irritability. This support contributes to easing the overall symptom load, supporting general well-being during symptomatic phases. The therapy is also considered relevant for easing localized signs of urogenital atrophy (e.g., vaginal dryness and burning) and may assist with managing symptoms related to the absence of a menstrual cycle.

“This therapy contributes to improved comfort during periods of heightened discomfort by providing necessary hormonal support.”

Quick Fact Therapeutic Application
Main Use Supportive relief for symptoms related to systemic imbalance and reproductive deficiency.
Long-term Benefit Plays a role in managing the long-term risks associated with maintaining skeletal health.

Eligibility and Restrictions for Use

The regulatory use of Cyclo-Progynova is strictly limited to women experiencing estrogen deficiency symptoms who possess an intact uterus, which is required for the sequential progestogen component.

The medicine is contraindicated and must not be used in patients with a history of or suspected breast cancer or other sex hormone-dependent malignancies. Absolute non-eligibility also applies to patients who have experienced blood clots (venous or arterial thromboembolic events) or have known thrombophilic disorders. Patients with severe liver disease, liver tumours, or severe hypertriglyceridaemia are also prohibited from use.

Furthermore, use is contraindicated during both pregnancy and lactation, and the medicine is not indicated for children and adolescents under 18 years of age. Use is conditional for patients with conditions like hypertension, diabetes, endometriosis, and migraine, requiring close professional observation. Patients with renal disorders are a use-not-established group, as official data on this population is unavailable.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The hormone components of Cyclo-Progynova may interact with several medicinal products, primarily by changes in drug metabolism or clearance, which can reduce its effectiveness or affect the safety and efficacy of the co-administered medication.

Do Not Combine (Contraindicated): The use of this product is contraindicated with medicines for treating Hepatitis C Virus (HCV) containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir. This combination has been documented to cause significant increases in the liver enzyme alanine aminotransferase (ALT).

Interactions Affecting Hormone Levels: Certain medicines can reduce the concentration of the estrogen and progestogen components by inducing hepatic microsomal enzymes (mainly CYP3A4), leading to increased hormone clearance. These include anticonvulsants (e.g., phenytoin, barbiturates, carbamazepine), antibiotics (e.g., rifampicin, penicillins, tetracyclines), and the herbal product St. John's wort.

Interactions Affecting Co-administered Drugs: Cyclo-Progynova may influence the pharmacokinetics of other medicines. For example, it can increase the blood levels of ciclosporin and atorvastatin, and it can reduce the blood levels and therapeutic effect of lamotrigine. Dosage adjustments or close clinical and laboratory monitoring of these co-administered drugs may be necessary.

Mechanism of Action

Cyclo-Progynova is a combination regimen containing estradiol valerate and norgestrel. Estradiol valerate functions as a prodrug which undergoes cleavage by esterases in the liver and blood, generating 17beta-estradiol.

The estradiol moiety acts as an agonist at nuclear estrogen receptors (ERs), specifically ERalpha and ERbeta, which are located in target tissues such as the uterus, bone, and brain. Upon ligand binding, the receptor-ligand complex dimerizes, translocates to the nucleus, and binds to Estrogen Response Elements (EREs) on DNA. This interaction modulates the transcription of estrogen-responsive genes, leading to systemic physiological modulation of estrogen-dependent processes.

Subsequently, norgestrel is introduced, the active form of which, levonorgestrel, acts as an agonist at the progesterone receptor (PR). This interaction leads to a cellular cascade in the endometrium that counteracts the proliferative effect induced by the estrogenic component. The periodic presence of progestogen triggers the structural change and subsequent shedding of the estrogen-stimulated endometrial tissue, resulting in a cyclical systemic physiological pattern.

Dosage and Administration Information

Cyclo-Progynova is administered through an oral route using coated tablets supplied in a sequential calendar pack. The regimen is structured as a fixed, repeating 28-day cycle, reflecting its classification as a sequential hormone therapy.


Official Dosing Regimen

The standard protocol involves taking one sugar-coated tablet daily for 21 consecutive days, followed by a 7-day tablet-free interval. The active 21-day period is sequenced: it begins with 11 white tablets containing only estradiol valerate (2 mg), followed by 10 light brown tablets which combine estradiol valerate (2 mg) and norgestrel (0.5 mg).


Administration Timing and Procedure

For patients who are still menstruating, the initial course begins on Day 5 of the menstrual cycle, whereas those with amenorrhoea or those who are postmenopausal may commence administration immediately once pregnancy has been ruled out. To ensure consistency of the hormonal pattern, the tablets should preferably be swallowed whole with liquid at approximately the same time every day.

Procedural Rules

General guidelines are provided for adherence to the schedule. If a tablet is forgotten at the usual time and more than 24 hours have passed, the missed dose is not taken, and the standard schedule continues. Furthermore, no dose adjustment is generally required for older adults or patients with mild to moderate hepatic impairment. The overall approach is to use the lowest effective dose for the shortest duration consistent with therapeutic goals.

Recent Clinical Evidence

Research Evidence: Overview of Clinical Studies for Cyclo-Progynova

The research base for Cyclo-Progynova (estradiol valerate/norgestrel), like many sequential Hormone Replacement Therapies (HRT), is compiled from clinical trials and large-scale, long-term observational studies across the entire HRT class. Studies have focused on what was observed when the medicine is used in research exploring how symptoms change over time and how certain physical markers were monitored in studies. This summary describes the evidence landscape without offering clinical advice.


Evidence for the Management of Climacteric Symptoms

Research has utilized short-term Randomized Controlled Trials (RCTs) and systematic reviews applied in studies examining patient-reported experiences of menopausal discomfort. Research monitored changes in the frequency and intensity of vasomotor symptoms, such as hot flashes and excessive sweating, in women with an intact uterus.

Studies monitored outcomes capturing phases of heightened symptom activity using standardized scales to track how symptoms evolved in the observed populations. Research describes patterns observed in the studies related to changes in these scores. A limitation is that the primary data often comes from trials with relatively modest sample sizes and follow-up durations were limited, typically lasting only four to six months.

Evidence on Endometrial Protection and Uterine Health

Research has examined the inclusion of the progestogen component (Norgestrel) in response to patterns of tissue change that were observed in some studies where estrogen was used alone. Studies monitored how the sequential administration of the progestogen related to observed tissue changes in the uterus. Research describes patterns where the combined approach was studied for its influence on the broader evidence landscape of the uterus.

Evidence Pertaining to Postmenopausal Bone Loss

Research also explored the medicine’s use in studies that monitored outcomes related to skeletal health. Observational studies and some RCTs, particularly those tracking the effects of HRT on Bone Mineral Density (BMD), have been utilized. Research highlights that studies have examined whether the use of this type of therapy may be associated with different patterns in bone mineral density compared to untreated groups.

Key Limitations and Research Gaps

A major limitation is the frequent reliance on the class effect for long-term endpoints like bone health and cardiovascular markers, meaning the data is drawn from various estrogen/progestogen combinations. Data for a number of intermediate outcomes are not yet fully established, and follow-up durations were limited in many core efficacy trials, meaning that long-term safety and outcome patterns are often inferred rather than directly observed in dedicated RCTs.

Key Studies & References

  1. Management of unscheduled bleeding on hormone replacement therapy (HRT) - British Menopause Society (BMS) Guideline
  2. Progestogens and endometrial protection - British Menopause Society (BMS) Consensus Statement
  3. Combined continuous hormone replacement therapy: a critical review (Discusses sequential HRT comparison)

Frequently Asked Questions (FAQ)

Common questions about Cyclo-Progynova (FAQ)


Q: Why does Cyclo-Progynova have two different colored tablets in the pack?

The different colors reflect the change in the tablet’s active content across the 21-day cycle, according to official product information. The white tablets contain only the estrogen component, estradiol valerate. The light brown tablets contain both estradiol valerate and the progestogen component, norgestrel.


Q: What is the purpose of the 'progestogen' part (Norgestrel) in the treatment cycle?

The progestogen component, norgestrel, is included to counteract the proliferative effect of estrogen on the lining of the uterus (endometrium). This step addresses a documented concern, as taking estrogen alone has been associated with excessive growth of the uterine lining (endometrial hyperplasia). The progestogen helps manage this growth.


Q: Is the term 'sequential' or 'cyclical' used to describe how this medicine is taken?

Cyclo-Progynova is formally classified as a Sequential Hormone Replacement Therapy and is administered using a cyclical schedule. This schedule involves taking active pills for 21 days followed by a 7-day tablet-free interval, according to the official dosing regimen.


Q: What is the distinction between the white and brown tablets in the package?

The distinction is based on the combination of hormones. The white tablets contain only the estrogen component, estradiol valerate. The light brown tablets contain the combined dose of estradiol valerate and norgestrel, which provides the necessary progestogen component for the second half of the cycle.


Q: Is this medicine used only for menopause symptoms?

No. While primarily used for the relief of menopausal symptoms resulting from estrogen deficiency, some official documents also list its use for other conditions. These may include certain hormonal disturbances that lead to missing or irregular periods, as well as the prevention of postmenopausal bone loss.


Q: What are the other medical conditions that Cyclo-Progynova is approved to treat?

Approved uses for this medicine include the treatment of estrogen deficiency symptoms in women with an intact uterus. It is also indicated for managing irregular menstrual bleeding due to hormonal imbalance and for the prevention of postmenopausal osteoporosis, according to regulatory guidance.


Q: Does taking this medication affect my natural menstrual cycle?

For women who are still menstruating, the treatment regimen is designed to replace the natural cycle with a regulated, cyclical pattern. The active pills are designed to establish a regular pattern resulting in a withdrawal bleed.


Q: What should I generally expect regarding my cycle while using this medicine?

A withdrawal bleed is typically observed during the 7-day tablet-free interval. Official product information indicates that irregular bleeding or spotting may occur, particularly during the initial months as the body adjusts to the hormonal regimen.


Q: Do the side effects typically go away after the first few months of use?

Official product information notes that certain adverse effects, such as breast tenderness or pain, are reported as more frequent during the initial months of treatment. However, regulatory documentation does not guarantee that all side effects will subside entirely.


Q: Is there a link between Cyclo-Progynova and weight gain, as described in studies?

Weight changes (either gain or loss) are listed as a Common side effect in official regulatory labeling for this medicine. This is classified as an event reported in between 1 in 10 and 1 in 100 users.


Q: Can Cyclo-Progynova cause mood changes or headaches?

Yes. Headaches are listed as a Very Common side effect, meaning they are reported in 1 in 10 or more users. Additionally, depressive mood and dizziness are listed as Common side effects, which may include changes in mood.


Q: What happens if I forget to take a tablet? (General fact-based clarification)

The official protocol states that if more than 24 hours have passed since the tablet was due, the missed dose is generally not taken, and the individual continues with the standard schedule. Regulatory documentation notes that missing doses may increase the chance of breakthrough bleeding.


Q: Does Cyclo-Progynova interact with common over-the-counter pain relievers?

The official label names specific drug classes that interact with the medicine. While the labels do not list all over-the-counter pain relievers, they often note that the drug may influence the effect of other medicines. This information should always be reviewed by a qualified professional.


Q: Are there any known interactions between Cyclo-Progynova and herbal supplements?

Yes. Official product information specifically notes an interaction with the herbal product St. John's wort. This supplement is known to increase the rate at which the body breaks down the hormones, which may reduce the medicine’s overall effectiveness.


Q: What does official guidance say about smoking while taking Cyclo-Progynova?

Official guidance notes that smoking is a known risk factor for serious adverse events associated with Hormone Replacement Therapies, such as blood clots and arterial events. It is noted that individuals should inform their healthcare professional if they smoke.


Q: Is the drug approved for use in women who have had a hysterectomy?

No. According to regulatory documentation, the use of Cyclo-Progynova is strictly limited to women who possess an intact uterus. Women who have had a hysterectomy generally use estrogen-only HRT regimens, as the progestogen component is not required.


Q: How is Cyclo-Progynova described in relation to managing hot flashes?

The medicine is indicated for the relief of symptoms caused by estrogen deficiency. These symptoms, known as climacteric symptoms, specifically include vasomotor symptoms such as hot flashes and excessive sweating.


Q: Does Cyclo-Progynova contain the same hormones as birth control pills?

Cyclo-Progynova contains estradiol valerate and norgestrel. While many birth control pills also use norgestrel (or its active form), they generally use a different, synthetic form of estrogen called ethinylestradiol. This means the specific hormone combination differs between the two types of medication.


Q: Is it common for people to report bloating when starting Cyclo-Progynova?

Official labeling lists swelling (edema) and abdominal pain as common side effects. While the term 'bloating' itself is not explicitly listed, these common effects are related to fluid retention and abdominal discomfort.


Q: Can Cyclo-Progynova affect results of laboratory blood tests?

Yes. According to regulatory documents, hormone replacement therapies can influence the results of certain laboratory tests. These tests may include those used to measure the function of the thyroid, liver, and kidney, as well as blood clotting factors.


Q: What are the commonly reported symptoms of an allergic reaction to the drug ingredients?

Official documents list hypersensitivity reactions as an uncommon side effect. While not all specific symptoms are listed, a general allergic reaction can involve symptoms such as hives, a skin rash, itching, and swelling.


Q: Do people typically take this medication with or without food? (Informational, non-directive)

The tablets should preferably be swallowed whole with some liquid at approximately the same time every day. Official patient information leaflets indicate that the medication may be administered with or without food.


Q: Do people report feeling tired or fatigued while on this medication?

Official side effect information lists headache (very common) and dizziness (common) as possible adverse effects. These common occurrences are considered possible factors contributing to feelings of tiredness or fatigue.


Q: How long does the medicine stay in the body after I stop taking it?

The active estrogen component, estradiol, has an elimination half-life that is generally in the range of 12 to 20 hours following oral administration. The half-life describes the time it takes for half of the dose to be cleared from the body.


Q: Are there any specific organs or body systems that require monitoring while taking Cyclo-Progynova?

Yes. Official regulatory labeling mandates regular medical examinations for users of this medicine. These checks typically involve monitoring blood pressure, conducting breast examinations, and assessing for conditions that require careful observation, such as diabetes and liver function changes.


Q: What is the mechanism by which certain liver enzyme inducers can interact with this drug? (High-level explanation)

Certain medicines can cause the liver to produce more enzymes, which is the body's natural system for breaking down hormones. When this happens, the hormones in Cyclo-Progynova are broken down and cleared from the body more quickly. This process can reduce the amount of the hormone circulating and therefore decrease the medicine's intended effectiveness.

How should Cyclo-Progynova be stored and disposed of?

How to Store and Dispose of Cyclo-Progynova?

Strict storage and disposal requirements for Cyclo-Progynova are defined in official regulatory documents to ensure the product’s quality and safety. The tablets must be stored at a temperature not exceeding 30 C.

To protect the medicine from moisture and maintain its stability, it must be kept in the original packaging.

All medicine should be stored out of the sight and reach of children to prevent accidental ingestion.

Disposal instructions mandate that the product must not be taken after the expiry date printed on the pack and blister. Any expired, unused, or damaged medicine must be returned to a pharmacist or local drug take-back program for proper disposal, preventing environmental contamination.

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

Available in countries:

Equivalent of Cyclo-Progynova found in:

A-Z Index: