Endometriosis

Endometriosis is a chronic condition that affects the tissue that lines the uterus (endometrium). The abnormal tissue called endometrial implants grows outside of the uterus in other areas of the body, including ovaries, bowel, rectum, bladder, and the lining of the pelvis. When this occurs there may be: pain, irregular vaginal bleeding, and frequently infertility. Endometriosis affects five to 10% of women. The most common treatment is oral contraceptives; it is rare to find women who do not respond to oral contraceptives for the symptoms of endometriosis. Birth control pills help control the hormones responsible for the buildup of endometrial tissue each month and taking the pill long-term may reduce or eliminate the pain of endometriosis. Most women also have lighter and shorter menstrual flow when taking the pill.

Commonly Prescribed (On-Label) Drugs: Danazol, Goserelin, Leuprolide, Nafarelin, Norethindrone

Off-Label Prescription Drugs Breakthrough Options: Levonorgestrel-Ethinyl Estradiol, Medroxyprogesterone Contraceptive Injection, Medroxyprogesterone Acetate, Mifepristone, Norethindrone Acetate-Ethinyl Estradiol, Norgestrel-Ethinyl Estradiol, Norgestimate-Ethinyl Estradiol

Mastalgia

Mastalgia is defined as breast pain and tenderness. Women may experience mastalgia with their monthly ovulation, called cyclic, or mastalgia that does not follow any pattern, called noncyclic. Cyclic pain is the most common and may be caused by hormone changes. It is usually felt in both breasts or as sensations in the underarm region. Noncyclic breast pain is present at all times in a specific area and is not affected by a woman’s menstrual cycle. Severe breast pain is a common symptom, affecting up to 70% of women at some time in their lives. It accounts for approximately 50% of referrals to a specialized breast clinic, two-thirds of women having cyclical and one-third experiencing noncyclical mastalgia. Most women require reassurance only, and the pain often subsides spontaneously after a few months. For the remainder, simple lifestyle changes are suggested initially, such as wearing a well-fitted sports bra, weight reduction, regular exercise and a reduction in caffeine intake. In only 15% of women is the pain severe enough to affect their lifestyle and warrant drug therapy.

Commonly Prescribed (On-Label) Drugs: None

Off-Label Prescription Drugs Breakthrough Options: Bromocriptine, Danazol, Tamoxifen

Pelvic Congestion

Sometimes chronic pelvic pain does not have an identifiable cause. When testing has ruled out endometriosis, fibroids, and uterine prolapse and there are no obvious signs of inflammation, pelvic congestion syndrome may be the source of debilitating pain. This is a common problem in women of reproductive age but the causes are poorly understood. There are several possible explanations, including: undetected irritable bowel syndrome or possible vascular problems. Because the underlying causes are poorly understood, treatment usually focuses on relieving the symptoms.

Commonly Prescribed (On-Label) Drugs: None

Off-Label Prescription Drug Breakthrough Option: Goserelin, Leuprolide, Medroxyprogesterone Acetate

Pelvic Pain, Chronic

Chronic pelvic pain is a common problem among women of reproductive age. Its cause is poorly understood. Chronic pelvic pain is diagnosed when: it has been present for six or more months, it is unresponsive to conventional therapy, and when the degree of pain seems greater than the identifiable tissue damage. Emotional and physical problems are usually present. Because chronic pelvic pain is poorly understood, treatment is often not satisfactory. Many people may have bladder or bowel dysfunction, sexual dysfunction or other systemic symptoms. Chronic pelvic pain is estimated to affect one in seven women in the United States.

Commonly Prescribed (On-Label) Drugs: None

Off-Label Prescription Drugs Breakthrough Options: Goserelin, Leuprolide, Medroxyprogesterone Acetate

Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries with multiple small cysts, an abnormally high number of ovarian follicles at various stages of maturation, and a thick scarred capsule surrounding each ovary. The syndrome includes: absence of menses (amenorrhea), infertility, unwanted hair (hirsutism), and enlarged polycystic ovaries. Polycystic ovary syndrome occurs as a result of abnormal hormonal regulation.

Commonly Prescribed (On-Label) Drugs: None

Off-Label Prescription Drugs Breakthrough Options: Medroxyprogesterone Acetate, Metformin, Levonorgestrel-Ethinyl Estradiol, Norethindrone Acetate-Ethinyl Estradiol, Norgestimate-Ethinyl Estradiol, Norgestrel-Ethinyl Estradiol, Spironolactone

Uterine Fibroids (Leiomyomas)

Uterine fibroids are among the most common noncancerous tumors found in women of reproductive age. Also called fibromyomas, leiomyomas, and myomas, they are not associated with an increased risk of uterine cancer and almost never develop into cancer. Most of the time uterine fibroids are not harmful. As many as three out of four women have uterine fibroids. Typically, fibroids cause no problems so women are often unaware that they have them. When problems do occur (in about one out of four women), they are generally found in the 30- and 40-year age group.

Commonly Prescribed (On-Label) Drugs: Leuprolide

Off-Label Prescription Drug Breakthrough Option: Mifepristone

Vaginal Ulceration

Vaginal ulceration can occur as the primary or secondary event in a large variety of conditions. These include infections, autoimmune and/or inflammatory diseases and dermatoses, neoplasias, and conditions with unknown causes. Ulcerating lesions of the vagina may be solitary or multiple and painful or nontender. Solitary, nontender ulcers are characteristic of syphilis, lymphogranuloma venereum, and neoplasia. Multiple painful ulcers occur in herpes simplex virus, Behçet’s syndrome, and Crohn’s disease. Laboratory evaluation is often necessary to determine the causes of vulvar ulcers.

Commonly Prescribed (On-Label) Drugs: None

Off-Label Prescription Drug Breakthrough Option: Sucralfate

Vulvodynia (Vulvar Dysesthesia)

Vulvodynia is characterized by widespread burning pain throughout the vulvar region (vilva and external genitalia) lasting a minimum of three months. This condition is considered by many to reflect a disease of the distal nerves of the affected areas because of the burning quality of the pain. Pain may be present in the labia, clitoris, vestibule, perineum, mons pubis, and inner thighs. The pain may be constant or unprovoked by touch or pressure to the vulva.

Commonly Prescribed (On-Label) Drugs: None

Off-Label Prescription Drugs Breakthrough Options: Amitriptyline, Desipramine, Tegretol, Nortriptyline

Hirsutism

Hirsutism is a condition in which too much hair grows on the face or body. Although hirsutism can occur in both men and women, it is usually only a problem for women. Women with hirsutism have dark, thick hair on their face, chest, abdomen and back. This hair is different from the hair that some women have on their upper lip, chin, breasts or stomach, or the fine “baby” hair all over their body. Women from certain ethnic groups tend to have more body hair than others. This does not mean that they have hirsutism. It is generally caused by abnormally high levels of male hormones called androgens. Conditions such as polycystic ovary syndrome, Cushing’s disease, and tumors in the ovaries or adrenal glands are common causes of hirsutism. Other causes may be from certain medications or hair follicles that are overly sensitive to male hormones. All combination oral contraceptives are beneficial for treating hirsutism.

Commonly Prescribed (On-Label) Drugs: Eflornithine

Off-Label Prescription Drugs Breakthrough Options: Dexamethasone, Finasteride, Flutamide, Ketoconazole, Leuprolide, Levonorgestrel-Ethinyl Estradiol, Medroxyprogesterone Acetate, Norethindrone Acetate-Ethinyl Estradiol, Norgestimate-Ethinyl Estradiol, Norgestrel-Ethinyl Estradiol, Spironolactone

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