Annovera

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Annovera

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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 Annovera

What is the Annovera System and its Unique Design?

Annovera is a form of combined hormonal contraceptive (CHC), a class of medication that delivers two types of synthetic hormones—an estrogen and a progestin—to prevent pregnancy. This product is distinct because it is engineered as a reusable vaginal ring, a flexible polymer system that is utilized for up to thirteen cycles (one full year) of therapy. This reusable design is a key differentiator from monthly ring systems, offering a non-daily, self-managed systemic contraceptive option. The system is designed to provide effective and reversible contraception, serving as a patient-controlled option for preventing pregnancy over an extended duration.


What Hormones and Components Does Annovera Contain?

The Annovera ring contains two active ingredients: Ethinylestradiol (an estrogen) and Segesterone acetate (a synthetic progestin). Segesterone acetate is a highly selective progestin developed specifically for this system, characterized by a high affinity for the progesterone receptor. This selectivity is a differentiating factor, as it limits interaction with other hormone receptors. The unique silicone elastomer composition of the ring ensures a controlled, continuous diffusion of both synthetic substances into the body, a delivery method that bypasses the hepatic first-pass metabolism associated with oral contraceptives.


What is the Primary Purpose of the Annovera Ring?

The primary purpose of Annovera is to provide effective contraception for females of reproductive potential. Its function relies on the systemic presence of the released hormones to interrupt the natural reproductive process. This interruption is achieved primarily by suppressing ovulation and secondarily by causing the cervical mucus to thicken, creating a physical impediment to sperm transit. The design of the sustained-release vaginal system allows for a consistent contraceptive effect that minimizes the potential for effectiveness loss associated with daily dosing adherence.

What side effects are possible with Annovera?

Possible Side Effects and Safety Information

Official regulatory documentation structures the safety profile of the Annovera system by grouping possible adverse reactions into frequency categories and physiological systems.


Frequency-Classified Adverse Reactions

The most frequently reported adverse reactions, classified as Very Common (occurring in ge10% of users) or Common (occurring in ge5% of users) in regulatory studies, affect several systems. These frequently reported effects include headache or migraine, nausea and vomiting, abdominal pain, and effects categorized as Reproductive System and Breast Disorders such as vaginal discharge, dysmenorrhea, and vulvovaginal candidiasis.


Serious Adverse Reaction Documentation

The most serious documented risk associated with combined hormonal contraceptives, including Annovera, relates to Vascular Disorders. This risk involves the potential for Thromboembolic Events, which are blood clots that can lead to Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Stroke, or Myocardial Infarction. The regulatory label also notes the risk of developing Liver Tumors (hepatic neoplasms).


Safety-Related Restrictions and Considerations

The medicine is subject to several strict restrictions. It is contraindicated in individuals with a history of or current venous or arterial thrombotic disease, undiagnosed abnormal uterine bleeding, or certain estrogen- or progestin-sensitive cancers. A critical population-specific safety consideration applies to females aged 35 years and older who smoke, a group for whom use is contraindicated due to a significantly increased risk of serious cardiovascular events. Furthermore, the official label includes a limitation of use for patients with a high Body Mass Index (BMI) due to insufficient data and observed risk.

This structure ensures that the primary risks and safety constraints are clearly communicated as defined by government health authorities.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the officially documented manifestations and mandated actions in the event of an overdose involving the Annovera System (Ethinylestradiol and Segesterone acetate), strictly as noted in government regulatory labeling.


Documented Manifestations and Actions

The overdose profile is defined by specific clinical signs. Nausea and vomiting are the primary acute manifestations documented in regulatory summaries. Additionally, withdrawal bleeding (vaginal bleeding) is a documented sign that may occur following exposure to excessive hormone levels. Overdose is generally stated by regulators as not being associated with serious adverse outcomes in healthy adults.


Required Emergency Response

The regulatory guidance is explicit: seek immediate medical attention or contact a poison control center immediately for any suspected overdose event or accidental ingestion.

Management focuses on symptomatic and supportive treatment, as the official prescribing information confirms that no specific pharmacological antidote is known for reversing the effects of the active hormones. Clinical observation may be required. A specific consideration noted in official documents is the potential for withdrawal bleeding if accidental ingestion occurs in young females.

Therapeutic Uses of Annovera

What Annovera Treats: Main Uses and Benefits

High-Efficacy, Long-Term Protection Against Pregnancy

The Annovera system's primary application is to provide highly effective protection against unintended pregnancy in females of reproductive potential. This system is commonly used in the clinical context of long-term fertility management. Key indications include prevention of pregnancy and fertility control. The unique reusable design is relevant in contexts where the patient experiences symptoms related to adherence challenges. It is applied in situations where the patient requires a non-daily, self-managed regimen.

Supportive Benefits for Comfort and Adherence

This benefit may assist with easing the difficulty of remembering a daily pill. The non-daily commitment may contribute to maintaining a sense of stability during long-term contraception. Ancillary benefits include addressing symptom groups like potential adverse weight changes, acne aggravation, or breast tenderness sometimes associated with hormonal methods. The system is associated with a profile that may support patient comfort for symptoms that may create noticeable physiological strain.

Quick Fact: Support for Adherence Challenges The system is commonly used when difficulties with daily routine adherence may interfere with functional stability, providing support that helps ease the overall burden of remembering medication.

Eligibility and Restrictions for Use

Annovera (segesterone acetate and ethinyl estradiol vaginal system) is a combined hormonal contraceptive indicated for use by females of reproductive potential to prevent pregnancy. It is generally not recommended for use before the start of menstruation or in post-menopausal women.


Contraindications

Annovera should not be used by women who have certain medical conditions or risk factors, as its use can increase the risk of serious side effects, such as blood clots (thrombosis), heart attack, or stroke. Do not use Annovera if you have:

  • A high risk of arterial or venous thrombotic diseases, including a history of blood clots, stroke, heart attack, or certain heart conditions.
  • Uncontrolled high blood pressure or high blood pressure with blood vessel damage.
  • Liver problems, such as liver tumors, acute hepatitis, or severe decompensated cirrhosis.
  • Known or suspected breast cancer or other estrogen- or progestin-sensitive cancers.
  • Undiagnosed abnormal uterine or vaginal bleeding.
  • Migraines with aura (sensory changes before or during the headache).
  • Are over age 35 and smoke.
  • Are pregnant or have given birth within the past four weeks and are not breastfeeding.

It is also not adequately studied in females with a Body Mass Index (BMI) greater than 29 kg/m^2.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines interactions with other substances and medicinal products as documented in official regulatory labeling.

Formal Contraindications and Major Restrictions

Annovera is formally contraindicated for co-administration with Hepatitis C drug combinations containing Ombitasvir/Paritaprevir/Ritonavir, with or without Dasabuvir, due to the potential for significant elevations of the liver enzyme Alanine Transaminase (ALT). The product is also contraindicated in females over 35 years of age who smoke, as this substance interaction significantly increases the risk of serious cardiovascular events.

Exposure-Altering Drug Interactions

Co-administration with strong CYP3A4 enzyme inducers, such as the antibiotic Rifampin or the herbal product St. John's wort, can cause a substantial decrease in the systemic exposure of Annovera's hormones. This official interaction pattern carries the risk of reduced contraceptive effectiveness. Conversely, strong enzyme inhibitors, such as Itraconazole, may cause an increase in hormone plasma concentrations.

Other Clinically Relevant Interactions

Annovera's hormonal components can alter the systemic levels of other medicines. For example, the estrogen component has been documented to cause a decrease in Lamotrigine plasma concentrations. Additionally, co-administration with oil-based vaginal products may increase the release rate of the hormones from the vaginal system, leading to elevated systemic exposure. For major surgery, administration must be stopped at least four weeks before and restarted two weeks after prolonged immobilization.

Mechanism of Action

The Annovera vaginal system releases two synthetic steroid hormones: segesterone acetate (a progestin) and ethinyl estradiol (an estrogen). These compounds enter the systemic circulation to modulate the neuroendocrine axis.

The primary biological target is the hypothalamic-pituitary-ovarian (HPO) axis. Segesterone acetate acts as a potent agonist at the progesterone receptor (PR), a nuclear transcription factor. This interaction, along with the influence of ethinyl estradiol, executes an antigonadotropic effect.

The combined action inhibits the pulsatile release of gonadotropin-releasing hormone (GnRH) from the hypothalamus, which subsequently suppresses the secretion of pituitary gonadotropins, specifically luteinizing hormone (LH) and follicle-stimulating hormone (FSH). The suppression of FSH prevents the selection and maturation of an ovarian follicle, and the absence of the midcycle LH surge prevents ovulation.

Downstream physiological consequences include thickening of the cervical mucus, which impedes sperm motility, and modification of the endometrial lining, which alters the uterine environment. These effects are the biochemical basis for the system-level modulation of the reproductive cycle.

Dosage and Administration Information

How to Use Annovera: Official Administration Guidelines

The Annovera system is a self-managed, reusable, combined hormonal contraceptive delivered via the vaginal route. Correct use is governed by a cyclic schedule and specific handling rules.

Official Dosing and Schedule

Feature Official Instruction
Route of Administration Vaginal (Self-inserted and self-removed)
Dosing Action Insert one vaginal system (ring)
Continuous Use Period Must remain in place continuously for 21 days (3 weeks)
System-Free Interval Followed by a 7-day ring-free interval
Annual Use One ring is reused for 13 cycles (one full year)

Procedural and Use-Context Instructions

Annovera is designed for use in a repeating 28-day cycle. During the 7-day interval, the ring must be cleaned with mild soap and warm water and stored in its case before re-insertion for the next cycle. The ring is designed to release an average daily dose of 0.15 mg of segesterone acetate and 0.013 mg of ethinyl estradiol.

Practical administration rules include adherence to lubricant compatibility: oil-based or silicone-based vaginal lubricants and medications should not be used, as they may compromise the system. The regimen is standardized for post-menarcheal adolescents and adults. A key use constraint is that the ring should be started no earlier than 4 weeks after delivery if the user is not breastfeeding.

Handling Instructions for Interruption of Use

If the Annovera ring is out of the vagina for a cumulative time of more than 2 hours during the 21 days of continuous use, there is a procedural constraint requiring the user to use an additional barrier method for 7 consecutive days after re-insertion.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Annovera


Evidence for use in Preventing Pregnancy

This section will summarize the main clinical trials that investigated the effectiveness of the Annovera vaginal system in preventing pregnancy. The summary will focus on how these studies were conducted and what they set out to measure regarding the ring's primary function.

Research conducted for Annovera focused on monitoring a large group of women over a defined time interval to see how often pregnancy occurred while they were using the ring as directed. These studies primarily looked at outcomes describing how well the system prevented pregnancy. The studies utilized a formula to describe pregnancy rates, and the findings describe patterns observed in these studied populations over one year of use. These studies were applied in research contexts involving fluctuating or unstable symptoms, such as the natural menstrual cycle, to monitor the use of the product.

Research explored patterns related to the primary outcome measured in the studies when Annovera was monitored consistently across one year. The research highlights changes measured during the study period and contributes to the research on this type of contraception. However, it is important to remember that these study results reflect the specific conditions under which they were conducted, and research does not determine whether an individual will respond similarly.

Long-term Studies and Follow-up

This section will summarize information from studies that tracked people using Annovera for longer periods (up to one year and beyond), outlining the monitoring of patient-reported experiences and continued use over extended periods. This will also describe any available data on outcomes after stopping use.

Studies explored the long-term patterns of Annovera, observing responses over defined time intervals to see if its use changed over a full year. The research examined outcomes related to systemic or functional imbalance and patient-reported outcomes describing perceived discomfort. Studies monitored whether the reported patterns remained similar throughout the full year of monitoring.

However, follow-up durations were limited, and data are still emerging. Long-term effects are not fully established beyond the time frame of the main clinical trials, and there is limited information for long-term outcomes extending several years.

Key Studies & References

  1. Segesterone Acetate/Ethinyl Estradiol Contraceptive Vaginal System (ANNOVERA) National Drug Monograph - VA.gov
  2. FDA Approves the First One-Year Contraceptive Fully under a Woman's Control - Population Council

Frequently Asked Questions (FAQ)

Common questions about Annovera (FAQ)


Q: How long does it take for Annovera to start working after the first use?

According to official product information, the timing of the first insertion is important for immediate protection. If the ring is started more than 5 days after the last menstrual bleeding, or when switching from certain other birth control methods, official product information advises that the use of an additional barrier method (such as a condom) should be considered for the first 7 days of use. This indicates that depending on the start day, an individual may not be fully protected, in accordance with the official schedule.


Q: Are there any foods or drinks that interact with Annovera?

Official labeling does not list specific food or drink interactions that directly affect the contraceptive effectiveness of Annovera. While official labeling does not list specific food or drink interactions, alcohol is mentioned in some general safety contexts as a substance that may potentially worsen common side effects like headache or nausea.


Q: Can Annovera cause changes in mood or anxiety levels?

Yes, official regulatory documents list both anxiety and mental depression as possible adverse reactions. The official labeling also indicates that the medication may cause or worsen depression in people with a history of the condition.


Q: Is there a higher risk of weight gain with Annovera?

Weight gain is not listed as one of the most common or very common side effects in the official Annovera labeling. However, changes in body weight are generally recognized as a potential adverse reaction associated with combined hormonal contraceptives (CHCs), which are the class of medication Annovera belongs to.


Q: Does Annovera protect against sexually transmitted infections (STIs)?

No. The official labeling for Annovera explicitly states that this medication does not protect against HIV infection (AIDS) or any other sexually transmitted infections (STIs). The use of barrier methods is the primary way to help prevent the transmission of STIs.


Q: What age group was Annovera primarily studied in?

The effectiveness and safety of Annovera were primarily evaluated in healthy women who were sexually active and between the ages of 18 and 40 years old during the main clinical trials used for approval.


Q: Is it normal if the ring feels uncomfortable at first?

Some users may notice or feel the vaginal ring, which is a known factor noted in acceptability studies. Official information indicates that high satisfaction rates were reported by users, which was evaluated based on factors like ease of use and comfort. Any persistent or significant discomfort warrants consulting a healthcare professional.


Q: Does sun exposure affect the effectiveness of Annovera?

Official product information notes that Annovera may increase the risk of chloasma, which is a form of skin discoloration. Individuals who tend to develop chloasma are advised in official product information to limit sun exposure or UV radiation, though exposure is not noted to reduce the contraceptive effectiveness of the ring.


Q: Are there any known issues with using tampons while using Annovera?

Official product information is not explicit about restrictions on tampon use. However, some studies have been required by the FDA to further evaluate the effects of tampon co-usage on the level of hormones released by the ring. Consulting official patient information or a healthcare professional can provide the most current guidance on simultaneous use.


Q: How quickly do side effects usually go away after starting Annovera?

For issues like unscheduled bleeding (spotting), official documentation suggests that this may resolve over time as the body adjusts to the medication. In clinical trials, the average number of days with unscheduled bleeding for those who experienced it was typically low, often one day or less per cycle. Any persistent or severe side effects should be addressed by a healthcare professional.


Q: Are there specific symptoms that require immediate medical attention while using Annovera?

The official label describes symptoms that warrant stopping use and seeking emergency medical help right away. This includes signs of a blood clot (e.g., sudden severe headache, chest pain, or trouble breathing). Users are also advised to watch for symptoms related to Toxic Shock Syndrome (TSS) or severe liver problems, as these also require immediate medical attention.


Q: Does Annovera interact with pain relievers like ibuprofen or Tylenol?

The official regulatory documents detailing drug interactions with Annovera do not list common over-the-counter pain relievers such as ibuprofen or acetaminophen (Tylenol) as formal drug interactions that are expected to alter contraceptive effectiveness or require a change in dose.


Q: Is it common for Annovera to cause changes to hair or skin?

Official documentation notes that skin discoloration (chloasma) is a possible side effect, especially in women with a history of the condition. There is no listing of hair loss as a common or very common adverse reaction in the official safety profile.


Q: Can I use Annovera if I have a history of depression?

Official documentation advises that individuals with a history of depression should inform their healthcare provider before starting Annovera. According to the official label, the use of this medication may cause new depression or worsen an existing depressive disorder.


Q: Does Annovera impact cholesterol levels?

Yes, official labeling indicates that combined hormonal contraceptives like Annovera can cause changes in the levels of fat (cholesterol and triglycerides) and sugar in the blood. The presence of uncontrolled high cholesterol or triglyceride levels is a factor healthcare professionals may consider when determining the appropriate contraceptive method.


Q: Does Annovera contain latex?

No. The official description of the product specifies that the Annovera vaginal system is not made with natural rubber latex. It is a silicone elastomer vaginal system.

How should Annovera be stored and disposed of?

Storage and Disposal Requirements for Annovera

The Annovera ring must be stored at controlled room temperature, specifically between 20^circC to 25^circC (68^circF to 77^circF), and protected from both freezing and excessive heat. The ring must also be kept out of direct sunlight. The product must be inserted before its printed expiration date.

In-Use Storage and Child Safety

During the 7-day ring-free interval, the cleaned vaginal system must be stored in the provided black compact case. The ring and the case must be kept out of the sight and reach of children and pets at all times.

Official Disposal Protocol

After completing the full 13 cycles of use (1 year), the used system must be placed back into its compact case for disposal. It should be discarded via a drug take-back program if one is available. If not, the system may be placed in the household trash. The used vaginal system must not be flushed down the toilet.

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

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