Glossary of Terms - Women

Anemia—Condition in which the number of red blood cells or amount of hemoglobin (the protein that carries oxygen within the cell) is below normal.

Application submitted—An application for marketing has been submitted by the company to the Food and Drug Administration .

Cervical dysplasia—The abnormal growth of cells on the surface of the cervix. Although it is not cancer, it is considered a precancerous condition. Most cases of cervical dysplasia occur in women ages 25 to 35, although it can develop at any age. While all causes of cervical dysplasia are not known, most cases of cervical cancer and severe dysplasia are caused by infection of the cervix with a persistent, high-risk strain of human papillomavirus. Cervical dysplasia is also called cervical intraepithelial neoplasia, or CIN.

Cervical intraepithelial neoplasia—Also called cervical dysplasia, or CIN.

Chronic fatigue syndrome—The symptoms of this illness include debilitating fatigue, interference with the ability to concentrate, and, in some cases, a low-grade fever and swelling of the lymph nodes. Many possible causes have been implicated, but the true cause remains unknown.

Chronic obstructive pulmonary disease (COPD)—The combination of chronic bronchitis and emphysema, in which there is a persistent disruption of airflow out of the lungs and eventual hypoxemia (low level of oxygen in the blood).

Dermatomyositis—An uncommon inflammatory disease marked by muscle weakness and a distinctive skin rash. Dermatomyositis may occur at any age, but it mostly affects adults in their late 40s to early 60s or children between 5 and 15 years. The signs and symptoms of dermatomyositis usually develop gradually, over weeks or months. Periods of remission, when symptoms of dermatomyositis improve spontaneously, may occur. Treatment can clear the skin rash and help patients regain muscle strength and function.

Dysmenorrhea—Painful or difficult menstruation.

Endometriosis—A condition in which cells lining the uterus (endometrium) are found in other parts of the pelvic cavity such as the ovaries. This results in pain and abnormal vaginal bleeding.

Fibromyalgia—Fibromyalgia syndromes are a group of disorders of unknown cause characterized by achy pain and stiffness in soft tissues, including muscles, tendons and ligaments. Fibromyalgia (pain and stiffness) may occur throughout the body or may be restricted to certain locations. A common variation, the primary fibromyalgia syndrome, usually occurs in previously healthy young women who may be depressed, anxious, or stressed, often with interrupted and nonrestorative sleep.

Glaucoma—An eye disease associated with increased pressure within the eyeball. If untreated, it may lead to permanent and complete blindness.

Human papillomavirus (HPV)— Viral agent of warts, believed to be contagious and mostly harmless, affecting only the skin’s topmost layer. HPV can lead to cervical cancer.

idiopathic thrombocytopenia purpura — A condition that may follow a viral infection, which can trigger destruction of blood platelets by the immune system. The reduced number of platelets may result in abnormal bleeding into the skin and from other parts of the body (purpura).

Incontinence, urinary—Uncontrollable, involuntary urination, often due to injury or disease of the urinary tract. Stress incontinence refers to the involuntary escape of a small amount of urine when a person coughs, laughs, picks up a heavy package or moves excessively.

Interstitial cystitis (IC)—A condition that results in recurring discomfort or pain in the bladder and the surrounding pelvic region. The symptoms vary from case to case and even in the same individual. People may experience mild discomfort, pressure, tenderness or intense pain in the bladder and pelvic area. Symptoms may include an urgent need to urinate (urgency), a frequent need to urinate (frequency) or a combination of these symptoms. Pain may change in intensity as the bladder fills with urine or as it empties. Women’s symptoms often get worse during menstruation. They sometimes may experience pain with vaginal intercourse.

Irritable bowel syndrome—The most common disorder of the large intestine (also called “spastic colon”) is a disturbance of involuntary muscle movement. It results in a combination of intermittent abdominal pain and irregular bowel habits.

Menorrhagia—Excessive uterine bleeding occurring at expected intervals of the menstrual periods. Bleeding from the uterus starts on schedule but is heavier than usual and may last longer than usual. Menorrhagia may be a sign of an underlying disorder, such as hormone imbalance, endometriosis, uterine fibroids or, rarely, cancer of the uterus. Menorrhagia may cause significant anemia.

Metrorrhagia—Uterine bleeding at irregular intervals, particularly between the expected menstrual periods. It may be a sign of an underlying disorder, such as hormone imbalance, endometriosis, uterine fibroids or, rarely, cancer of the uterus. Metrorrhagia may cause significant anemia.

Migraine—A chronic disease of severe headaches resulting from an abnormal dilation of blood vessels within the brain. It can last from two hours to two days and is often accompanied by nausea, vomiting and sensitivity to noise and/or light.

Multiple sclerosis (MS)—A chronic, often progressive disease of the central nervous system in which scattered patches of the covering of nerve fibers (myelin) in the brain and spinal cord are destroyed.

Myasthenia gravis—A chronic autoimmune neuromuscular disease characterized by varying degrees of weakness of the skeletal (voluntary) muscles of the body. The hallmark of myasthenia gravis is muscle weakness that increases during periods of activity and improves after periods of rest. Certain muscles such as those that control eye and eyelid movement, facial expression, chewing, talking, and swallowing are often, but not always, involved in the disorder. With current therapies, most cases of myasthenia gravis are not as “grave” as the name implies. For the majority of individuals with the disease, life expectancy is not lessened by the disorder.

Nephritis—Inflammation of the kidneys that is generally caused by an infection or an immune reaction that goes awry and injures the kidneys.

Osteoarthritis—The most common form of joint disease, characterized by degeneration of the cartilage that lines joints and by the formation of reactive bony outgrowths at the boundary of a joint.

Osteoporosis—The most common metabolic bone disease in older people in which a reduction in bone mass leads to fractures, especially of the vertebrae, hips and wrists.

Phase 0—First-in-human trials conducted in accordance with FDA’s 2006 guidance on exploratory Investigational New Drug (IND) studies designed to speed development of promising drugs by establishing very early whether the agent behaves in human subjects as was anticipated from preclinical studies.

Phase I—Safety testing and pharmacological profiling in humans.

Phase II—Effectiveness and safety testing in humans.

Phase III—Extensive clinical trials to demonstrate safety and efficacy in humans.

Preeclampsia—The development of hypertension with proteinuria or edema, or both, due to pregnancy or the influence of a recent pregnancy.

Premenstrual dysphoric disorder— More commonly known as premenstrual syndrome, or PMS, this is a condition in which a variety of symptoms, including nervousness, irritability, emotional upset, depression, headaches, tissue swelling and breast tenderness may occur during the week to 14 days before a menstrual period begins.

Prolactinoma—A noncancerous pituitary tumor that produces a hormone called prolactin, which results in too much prolactin in the blood.

Psoriasis—A skin disease characterized by thickened patches of inflamed, red skin often covered by silvery scales.

Rheumatoid arthritis—A type of arthritis that particularly attacks the small joints of the hands, wrists and feet. The joints become painful, swollen, stiff and, in severe cases, deformed.

Sepsis—Presence of bacteria and/or their toxins in blood or tissues throughout the body.

Systemic lupus erythematosus—A chronic autoimmune disorder affecting many systems of the body, including the kidneys and brain.

Vasomotor—Relating to the nerves and muscles that cause the blood vessels to constrict or dilate.