Estradiol Vaginal Inserts - Uses, Contraindications, and Side Effects

Introduction

Menopause is a normal phenomenon that occurs between the ages of 45 and 55 years, during which the ovaries do not release eggs, and the menstruation stops. Symptoms of menopause vary among women and may last for around five years. Symptoms of menopause include hot flashes (sudden feeling of warmth), night sweats, pain during sex (dyspareunia), vaginal infections, mood swings, vaginal dryness (vaginal atrophy), headache, joint pain, and decreased interest in sexual intercourse. These changes can significantly affect the individual's physical and mental health. Various medications are available these days that help manage postmenopausal symptoms and thus improve the quality of life.

What Are Estradiol Vaginal Inserts?

Estradiol vaginal insert is a medication used in the treatment of vaginal dryness, itching, or burning sensation in the vagina and dyspareunia, which are mainly caused due to reduced estrogen levels or menopause. It is a prescription medicine available as flexible rings or tablets to be inserted into the vagina. It belongs to a group of medications called hormones, which replace the estrogen normally produced in the body. Estradiol vaginal inserts are approved by the United States Food and Drug Administration (FDA) to relieve the postmenopausal symptoms in women.

How Is an Estradiol Vaginal Insert Used?

Estradiol vaginal inserts must be used as exactly directed by the doctor or mentioned in the patient leaflet. Hands must be thoroughly washed and dried before handling the medication. The larger end of the vaginal insert must be held between the fingers and inserted by either lying down or in the standing position, whichever is the most comfortable position for the patient. The smaller end must be upwards, and the insert must be placed about two inches into the vagina using the finger. It must be inserted in the vagina once a day for the first two weeks at about the same time, after which it can be used two times a week for as long as recommended. Estradiol vaginal inserts must be stored at room temperature between 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit) away from excess heat and moisture.

How Effective Are Estradiol Vaginal Inserts?

Many females suffer from postmenopausal symptoms due to the pathological changes occurring in the vagina that cause a decrease in the estrogen production. Estradiol vaginal inserts are recommended to be inserted twice a week. They are found to be highly effective as they readily supply estrogen, resulting in a significant improvement in the signs and symptoms of menopause. Studies have also demonstrated that using small doses of Estradiol does not increase the systemic blood level of estrogen hormone, thereby reducing the possibility of any unwanted side effects. It is also observed that local Estrogen treatment has favorable effects on sexual function, vaginal surgery, and incontinence.

What Is the Most Important Information About Estradiol Vaginal Inserts?

• Patients undergoing estrogen therapy are at an increased risk of developing uterine cancer (cancer of the uterus lining), stroke, and dementia (loss of memory, communication, or thinking abilities); the longer the use, the greater the risk. In patients who have not undergone a hysterectomy (surgical removal of the uterus), the doctor usually recommends progesterone along with Estradiol vaginal inserts. This may lower the risk of uterine cancer but can increase the risk of breast cancer, blood clots, or heart diseases.

• Patients must inform the doctor immediately if rash, severe itching, difficulty breathing, severe headache, speech problems, dizziness, fainting, or swelling of the eyes, throat, hands, and feet are observed.

• Patients must contact the doctor immediately if they notice lumps or any changes in the breast, nipple discharge, pain, redness in one leg, chest heaviness, double vision, or abnormal vaginal bleeding during the treatment.

• Estradiol vaginal inserts must not be used alone or with progesterone to prevent heart disease, dementia, or stroke. The doctor must be consulted before taking or stopping this medication.

• Patients must examine their breasts regularly or get a mammogram done periodically to detect breast cancer as early as possible.

What Are the Contraindications of Estradiol Vaginal Inserts?

Estradiol vaginal inserts are contraindicated in the following conditions:

• Allergic or has experienced hypersensitivity reactions to Estradiol vaginal inserts or its components.

• Patients suffering from or have a history of breast cancer, bleeding disorders, protein C deficiency, protein S deficiency, or liver diseases.

• Abnormal undiagnosed genital bleeding.

• Patients with active deep vein thrombosis (blood clots in a deep vein), pulmonary embolism (blood clot in the lungs), angioedema (swelling under the skin), estrogen-dependent malignancies such as ovarian cancer, uterine cancer, or have previously experienced myocardial infarction (MI) or stroke.

• Estradiol vaginal inserts are not recommended in pregnant and breastfeeding women.

What Are the Side Effects of Estradiol Vaginal Inserts?

The side effects of Estradiol vaginal inserts include:

• Nausea and vomiting.

• Diarrhea.

• Stomach pain.

• Hair loss.

• Bloating sensation.

• Difficulty or pain during urination.

• Vaginal discharge.

• Joint pain.

• Swelling, itching, or redness of the vagina.

• Difficulty sleeping.

• Headache.

• Changes in sexual desire.

What Are the Precautions to Be Followed Before Using Estradiol Vaginal Inserts?

• Patients must tell the doctor if they are allergic to Estradiol (estrogen), its ingredients, or any other medications before using Estradiol vaginal inserts.

• Patients suffering from liver diseases, blood disorders, cardiovascular diseases, unusual vaginal bleeding, endometriosis (tissue similar to uterus lining grows outside the uterine cavity), uterine fibroids (non-cancerous growth in the uterus), hypoparathyroidism (decreased production of parathyroid hormone), or any other medical conditions must inform the doctor before starting the treatment.

• Patients must notify the doctor if they are taking medications such as St.John’s wort, Rifampin, Itraconazole, Ketoconazole, Clarithromycin, Erythromycin, Carbamazepine, herbal or vitamin supplements, over-the-counter (OTC) drugs or any other medicines before taking Estradiol vaginal inserts.

• Female patients must inform the healthcare provider if they are pregnant, planning pregnancy, or lactating before beginning the treatment.

Conclusion

Estradiol vaginal inserts are recommended to manage moderate to severe pain during sexual intercourse and vaginal dryness due to menopause. It contains estrogen hormone in the form of rings, capsules, or tablets inserted into the vagina. It must be used exactly as instructed by the doctor, along with regular monitoring every three to six months. Estradiol vaginal inserts can be associated with certain side effects. Therefore, a healthcare provider must be consulted before using this medication.