Cyclofemina

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Cyclofemina

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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 Cyclofemina

Quick Facts: Cyclofemina

Property Description
Active Ingredients Estradiol Cypionate, Medroxyprogesterone Acetate
Form Injectable Suspension (Depot)
Pharmacological Class Combined Sex-Hormonal Preparation
Common Use Prevention of Pregnancy (Contraception)
Origin Synthetic Hormones

Cyclofemina: Identity and Pharmacological Classification

Cyclofemina is a combined sex-hormonal preparation classified as a combined injectable contraceptive (CIC), used exclusively for the prevention of pregnancy. This medication is a prescription-only product delivered via intramuscular injection as an injectable suspension. Cyclofemina is distinctive as one of the formulations originally developed through the World Health Organization (WHO) Human Reproduction Programme (HRP-112), a designation that confirms its public health relevance and clinically recognized efficacy. Unlike daily oral tablets, this long-acting format is specifically positioned for patients seeking a highly convenient and consistent monthly protection method.

What is Cyclofemina Made Of: Active Ingredients and Origin

Cyclofemina is a combination product containing two primary synthetic hormones: Estradiol Cypionate (the estrogen component) and Medroxyprogesterone Acetate (the progestin component). These components are chemically derived analogues, meaning they are synthetic hormones engineered for therapeutic use. Its dual composition distinguishes it from progestin-only alternatives. The drug's formulation as a microcrystalline aqueous suspension is supported by pharmacological studies that confirm its suitability as a depot preparation, allowing the slow, sustained release of the hormones from the injection site into the bloodstream.

Primary Purpose and Monthly Protection

The primary and sole general purpose of Cyclofemina is to provide highly reliable contraception, a typical use scenario being for women of reproductive age who prefer a monthly injection over daily pills. It works by using the combined power of its estrogen and progestin components to suppress ovulation, thicken cervical mucus, and alter the uterine lining. The main benefit to the user is its ability to offer dependable monthly protection following a single injection, contrasting with contraceptive methods that demand daily adherence.

Regulatory References

  1. WHO Special Programme on Human Reproduction (HRP) Timeline
  2. WHO Contraception Health Topic

What side effects are possible with Cyclofemina?

Possible Side Effects and Safety Information

The safety profile of Cyclofemina, a combined injectable contraceptive, is defined by adverse reactions categorized by frequency and the organ systems they affect, based on regulatory documentation.

Adverse Reactions Classified by Frequency

Official regulatory documents classify adverse reactions according to how often they are observed:

Classification Examples of Reactions
Very Common (ge 1/10) Irregular uterine bleeding (including spotting), amenorrhea, headache, abdominal pain.
Common (ge 1/100 to <1/10) Weight gain, breast pain/tenderness, depression, dizziness, nausea, fluid retention.

These effects are grouped into System-Organ Classes (SOCs), including Reproductive System and Breast Disorders, Nervous System Disorders, and Psychiatric Disorders.


Serious Adverse Reactions and Safety Constraints

The use of combined hormonal contraceptives is officially associated with an increased risk of serious adverse reactions, which are highlighted in regulatory warnings. These include the potential for Thromboembolic Events such as Deep Vein Thrombosis (DVT), Pulmonary Embolism, Stroke, and Myocardial Infarction. The risk of developing Hepatic Neoplasia (liver tumors) is also a documented, rare concern.

Official safety documents place restrictions on use in specific populations, such as women over the age of 35 who smoke, and individuals with a history of severe liver disease, a high risk of vascular disease, or undiagnosed abnormal uterine bleeding.

Regarding duration, some effects, particularly irregular bleeding and weight gain, are officially noted as being most frequent during the first year of use and may diminish thereafter.

Overdose and Emergency Response

Overdose and When to Seek Help

Cyclofemina is a combined injectable hormonal contraceptive containing medroxyprogesterone acetate and estradiol cypionate. Due to its formulation as a monthly intramuscular injection administered by a healthcare professional, accidental overdose is highly unlikely for typical users.

However, in the event that a dose significantly higher than prescribed is administered, or if a severe reaction occurs, the main concern is generally the high level of hormonal activity. Overdoses of similar estrogen/progestin combinations are usually not life-threatening but can cause notable symptoms. Treatment of overdose is typically supportive and involves discontinuing the medication and managing symptoms.

Potential Overdose Symptoms

Symptoms that may occur following an excessive dose of the hormonal components in Cyclofemina often mirror common side effects, but are more severe. These may include:

  • Nausea and Vomiting
  • Breast tenderness or pain
  • Dizziness or drowsiness
  • Vaginal bleeding, including heavy withdrawal bleeding several days after the event

When to Seek Emergency Medical Help

Contact emergency medical services (such as 911 in the U.S.) immediately if you or someone else experiences severe, sudden symptoms after a potential overdose, which may indicate a serious underlying condition, such as a blood clot. These critical symptoms include:

Symptom Category Specific Signs
Cardiovascular/Neurological Sudden severe headache, slurred speech, sudden weakness or numbness, chest pain, difficulty breathing, visual changes
Allergic Reaction Swelling of the face, lips, tongue, or throat; hives
Other Severe Signs Heavy, uncontrollable vomiting; extreme fatigue; dark urine or yellowing of the skin/eyes (jaundice)

For advice regarding less severe, but concerning, symptoms or for general overdose guidance, contact a Poison Control Center.

Therapeutic Uses of Cyclofemina

What Cyclofemina Treats: Main Uses and Benefits

The primary role of Cyclofemina is to serve as a method of contraception, addressing the risk of unintended pregnancy and supporting family planning goals. Its use is considered relevant for fertility control. Beyond this central function, it provides symptomatic relief and practical benefits related to reproductive health.


The medication is commonly used across domains where supportive symptom management is needed, including the risk of unintended conception, heavy menstrual bleeding, and painful cramping (dysmenorrhea). In clinical scenarios where patients require scheduled support to manage their reproductive status, the medication helps ease the overall burden and anxiety associated with the risk of unintended conception.

“The monthly injection schedule may be part of symptomatic management against conception risk while assisting with managing symptoms related to cycle regulation.”

This therapeutic support is also applied in addressing symptomatic patterns that create noticeable physiological strain, such as irregular or unpredictable bleeding. The benefit may support the development of a more predictable cycle pattern, which assists with maintaining functional stability and general well-being during symptomatic phases.


Quick Fact: Relief for Menstrual Discomfort
Symptom Domain: Menstrually related discomfort and heavy bleeding.
Common Use Context: Applied during phases when symptoms become more noticeable; helps ease pain and may assist with managing blood flow severity.
Primary Benefit: Contributes to improved comfort during periods of heightened symptoms.

Eligibility and Restrictions for Use

Who Can and Cannot Use Cyclofemina?

Cyclofemina is officially indicated for females of reproductive potential seeking contraception. Eligibility is strictly defined by official regulatory documentation, which outlines absolute prohibitions and specific restrictions for use.


Absolute Contraindications

The medicine must not be used by patients with a known or suspected pregnancy, a history of thromboembolic disorders (blood clots or stroke), or active thrombophlebitis. Use is also strictly prohibited for those with significant liver disease, undiagnosed abnormal uterine bleeding, known or suspected malignancy of the breast, or known hypersensitivity to the ingredients. Furthermore, official guidance states that women over 35 years of age who smoke must not use this medication.


Restricted and Conditional Use

While indicated for adolescents, long-term use (e.g., over two years) is not recommended in this group due to regulatory concerns regarding potential bone mineral density loss. In the postpartum period, use is restricted, with initiation only recommended at the sixth postpartum week if exclusively breastfeeding. Caution and monitoring are also required for individuals with certain pre-existing conditions, including hypertension and diabetes mellitus.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information regarding combined injectable contraceptives containing Estradiol Cypionate and Medroxyprogesterone Acetate (MPA) indicates that interactions primarily involve pharmacokinetic changes to hormone exposure.

Documented Interaction Patterns

The most significant interaction concerns drugs that depress hormone concentrations, potentially resulting in decreased contraceptive efficacy. The steroid synthesis inhibitor Aminoglutethimide may significantly depress the serum concentrations of the progestin component, MPA. Additionally, the estrogen component is partially metabolized by the CYP3A4 enzyme system.

Co-administration with CYP3A4 inducers (e.g., phenobarbital, rifampin, carbamazepine, St. John's Wort preparations) may reduce estrogen plasma concentrations, potentially decreasing therapeutic effects. Conversely, CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase estrogen plasma concentrations, which could lead to side effects. No formal drug-drug interaction studies were conducted for the combined product. No specific timing rules or formally contraindicated combinations are documented in the official regulatory information.

Mechanism of Action

Cyclofemina functions via the combined actions of its two steroid components, medroxyprogesterone acetate and estradiol cypionate. Estradiol cypionate, an estrogen receptor (ER) agonist, interacts primarily with ER alpha and ER beta located in target tissues, including the hypothalamus, pituitary gland, and ovaries. This agonism modulates the hypothalamic-pituitary-ovarian (HPO) axis by exerting a negative feedback effect on the pituitary gland, resulting in the suppression of gonadotropin-releasing hormone (GnRH) receptor expression and, consequently, the decreased secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH).

Simultaneously, medroxyprogesterone acetate, a progestin, acts as a progesterone receptor (PR) agonist. Activation of PRs in the pituitary reinforces the negative feedback loop on LH secretion and inhibits the mid-cycle LH surge. In the ovaries, the combined action of suppressed FSH and LH prevents the development of a dominant follicle and subsequent ovulation. Furthermore, the progestin component induces changes in the endometrium, promoting atrophy and hindering cellular proliferation, while also increasing the viscosity and cellular density of the cervical mucus.

Dosage and Administration Information

How to use Cyclofemina

The administration of Cyclofemina is strictly governed by a fixed, non-adjustable monthly schedule and is delivered via deep intramuscular injection. This long-acting formulation requires specific preparation and adherence to a rigid timeline to maintain its intended use pattern. The total dose is a 0.5 mL volume containing 25 mg Medroxyprogesterone Acetate and 5 mg Estradiol Cypionate per administration.


Administration Scope

Domain Instruction
Route of administration Intramuscular (I.M.) injection only.
Dosing schedule (as written in regulatory sources) Administered every 28 to 30 days. The first injection must occur within the first five days of a normal menstrual period.
Preparation requirements (if applicable) The vial must be shaken vigorously immediately before withdrawal to ensure the active hormones are uniformly suspended.
Age-group administration rules Use is indicated for postpubertal adolescents; use prior to menarche is not indicated.
Special procedural conditions The injection site (gluteal, deltoid, or anterior thigh) must be rotated with each monthly administration.

Instruction Classifications

Classification Detail
Administration method type Injectable (Depot suspension).
Frequency pattern Monthly cyclic (every 28–30 days).
Regulatory basis Based on standardized prescribing information.

Resulting Procedural Structure

Official step sequence:

  • Vigorously shake the suspension prior to use.
  • Administer the entire dose via deep intramuscular injection.
  • Maintain the fixed schedule, disregarding any intervening bleeding patterns.
  • If the interval exceeds 33 days, the possibility of pregnancy must be ruled out before the next dose is administered.

Connection to the overall use protocol

The official use protocol is designed around a precise, fixed monthly cycle that requires mandatory adherence to the defined interval. This structure dictates the required steps for preparing the specialized suspension and administering it via the deep intramuscular route under healthcare professional supervision. The protocol strictly defines the procedure for a delayed dose, necessitating a medical status check if the maximum 33-day limit is exceeded.

Recent Clinical Evidence

Evidence for Use in Preventing Unintended Pregnancy

Research into Cyclofemina's intended use—as a method of contraception—was conducted through large, international multicenter trials and comparative studies. These studies primarily examined the pregnancy rate within the observed populations, which is the main way researchers measure the contraceptive outcome of a method. The study populations were consistently women of reproductive age across many clinical settings globally.

These foundational trials generally described consistent patterns observed in the populations studied regarding the primary outcome of interest. Research also focused on continuation rates and reasons for discontinuation among the women studied. Findings contribute to the broader evidence landscape used by health regulators to understand the method's profile.


Research on Menstrual Cycle Patterns and Regulation

Research has also explored the patterns of the menstrual cycle during the use of this injection. These studies, which include comparative trials against other hormonal methods, were applied in studies examining patient-reported experiences of menstrual bleeding. The primary outcomes related to physical discomfort and systemic or functional imbalance were often studied, focusing on the occurrence of irregular bleeding, spotting, and cycle predictability.

In these studies, findings describe patterns observed in the populations studied regarding cycle regulation. Some evidence indicates that patterns related to bleeding were measured during comparisons with progestin-only injectable contraceptives. Research highlights the changes measured during the study period relating to the frequency and regularity of bleeding. These outcomes often reflect patient-reported outcomes describing perceived discomfort and continuation, rather than objective disease endpoints.


What Remains Uncertain in the Research Record

The research highlights what is known—and what is still uncertain. One of the primary limitations is the lack of long-term effects data; specifically, the incidence of major clinical events (like fractures or cardiovascular disease) remains low in certainty because the original regulatory trials had limited follow-up durations.

Furthermore, while changes in biochemical markers were observed in some studies, the clinical relevance of these shifts in lipids or bone density over decades of use is still uncertain. Subgroup findings for populations with pre-existing metabolic or bone health concerns are uncertain.

Key Studies & References Combination injectable contraceptives for contraception. Cochrane Database of Systematic Reviews.

Frequently Asked Questions (FAQ)

Common questions about Cyclofemina (FAQ)

Q: What is the main purpose of Cyclofemina?

A: According to official regulatory documents, the primary intended use of this combined injectable contraceptive, which contains medroxyprogesterone acetate (MPA) and estradiol cypionate (EC), is for the prevention of pregnancy (contraception). This information is generally found in the Indications section of the product labeling.

Q: How long does it typically take for Cyclofemina to start working?

A: Official product information describes a fixed monthly administration schedule for this injectable contraceptive. Key mechanisms of action, such as cervical mucus thickening to block sperm, are described in some studies as occurring within 24 hours after administration.

Q: Can Cyclofemina interact with common over-the-counter pain relievers?

A: Official information indicates that common over-the-counter pain relievers, such as acetaminophen and ibuprofen, are not reported to reduce the effectiveness of hormonal contraceptives. Official documents contain specific warnings regarding prescription drugs or herbal remedies in the dedicated interactions section.

Q: What is the typical time frame for side effects to appear after the first injection?

A: Official documentation notes that some of the most common effects, such as irregular uterine bleeding and weight changes, are reported as being most frequent during the first year of use. This frequency pattern means that these specific effects are commonly measured during the initial months following treatment initiation.

Q: Does Cyclofemina interact with any antibiotics?

A: Most commonly prescribed antibiotics are not reported to reduce the effectiveness of this type of hormonal contraception. However, antibiotics that belong to the rifamycin class (such as rifampin) are known to significantly reduce the hormone levels in the blood, which could potentially reduce effectiveness.

Q: Are there certain supplements or vitamins that should be avoided while using Cyclofemina?

A: Official regulatory documents specifically advise caution regarding St. John's Wort preparations. This herbal supplement is known to potentially reduce the concentration of the estrogen component in the blood, which may decrease the drug’s intended therapeutic effect.

Q: Can women with a history of migraines use Cyclofemina?

A: Official warnings state that combined hormonal contraceptives are contraindicated—meaning a specific condition makes the use of the drug unsuitable or potentially harmful—in women with a history of migraine with aura. This information is highlighted in the safety and contraindication sections of official drug labeling.

Q: How soon after stopping Cyclofemina does fertility typically return?

A: Studies indicate that after discontinuing progestin-containing injectable contraceptives, there is often a delay in the return to normal fertility, which may take several months. This is a common pattern observed with this method, rather than an immediate return to pre-treatment cycles.

Q: Do studies suggest any impact of Cyclofemina on bone density?

A: Studies related to the progestin component, medroxyprogesterone acetate (MPA), have shown that its use can lead to a decrease in bone mineral density (BMD). The amount of bone loss is generally described as increasing with the duration of use, and this is included in the warnings section of the drug's official labeling.

Q: Is there a maximum age limit for using Cyclofemina according to prescribing information?

A: Official regulatory warnings place specific restrictions on use for women over age 35 who smoke. This warning is related to the significantly increased risk of serious cardiovascular events, which is a known concern with combined hormonal contraceptives in this demographic.

Q: Can using Cyclofemina affect cholesterol levels?

A: Studies have observed changes in biochemical markers such as lipids (fats like cholesterol) in individuals using this drug. While these shifts are noted, the overall long-term clinical significance of these changes over decades of use is described as uncertain in the research record.

Q: Does Cyclofemina cause a temporary change in blood pressure?

A: Changes in blood pressure, including hypertension (high blood pressure), are listed in the adverse event sections as a possible side effect associated with the use of combined hormonal contraceptives.

Q: Can Cyclofemina make existing acne worse?

A: Official adverse event lists note that changes in the skin and hair, including the potential for worsening acne or changes in hair growth, are possible side effects linked to the hormonal component of this class of contraceptives.

Q: Do official prescribing documents mention any effect on libido from Cyclofemina?

A: Yes, official adverse event lists include changes in libido (sex drive) as a possible side effect that may be experienced while using hormonal contraceptives.

Q: What is the chance of pregnancy if Cyclofemina is used correctly?

A: Official efficacy data reported in clinical trials indicate that the contraceptive failure rate (pregnancy rate) for injectable contraceptives of this type is typically reported as less than 1 per 100 women per year with perfect use. This is the figure used in the efficacy summaries.

Q: Are there warnings about using Cyclofemina while breastfeeding?

A: Official regulatory documentation states that the use of combined hormonal contraceptives is not recommended for breastfeeding women in the first few weeks postpartum due to concerns about the risk of blood clots in the mother and the potential for adverse effects on milk supply.

Q: Is it possible to be allergic to Cyclofemina?

A: Official documentation states that the drug is contraindicated (meaning use is unsuitable or potentially harmful) in patients with a known hypersensitivity or allergic reaction to any of the components found in the formulation.

Q: What is the half-life of the active ingredients in Cyclofemina?

A: The pharmacokinetics section of official labeling defines the terminal half-life of the progestin component, medroxyprogesterone acetate (MPA). This half-life, which represents the time it takes for half of the drug to be eliminated from the body, is reported to be in the range of 40 to 60 hours.

Q: What is the definition of a 'contraindication' for Cyclofemina?

A: In medical terms, a contraindication is defined as any medical condition or factor that makes a specific treatment or procedure unsuitable or potentially harmful to an individual. The presence of a contraindication typically indicates that the drug should not be administered.

Q: Is there evidence that Cyclofemina can cause hair loss or thinning?

A: Changes in hair density, including hair thinning or loss, are noted as a possible side effect associated with the use of hormonal contraceptives. These types of changes are generally included in the list of observed adverse events.

Q: What are the key findings from major clinical trials of Cyclofemina?

A: Key findings from clinical trials established the drug's intended use in preventing pregnancy and provided data on its typical menstrual cycle patterns (e.g., irregular bleeding patterns) and the most common adverse events reported by participants.

How should Cyclofemina be stored and disposed of?

How to Store and Dispose of Cyclofemina

Official regulatory documents define strict storage and disposal requirements for Cyclofemina to maintain its stability and effectiveness.

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F). Do not freeze or expose to excessive heat.
Protection Keep the product in its original carton to protect it from light and moisture.
Child Safety The medicine must be kept out of the reach of children.
Stability As a single-dose injection, any unused portion of the vial or ampule must be discarded immediately after the required dose is withdrawn.

Disposal Instructions

Do not dispose of expired or unused Cyclofemina via household trash or down the sink/toilet. All used injection materials and unused product must be placed into a designated sharps container or disposed of through an approved pharmaceutical take-back program, in accordance with local regulatory waste guidelines.

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

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